{"id":"teclistamab","rwe":[{"pmid":"41892182","year":"2026","title":"Analyzing Real-World Infection Risk in Multiple Myeloma Patients Receiving Teclistamab.","finding":"","journal":"Current oncology (Toronto, Ont.)","studyType":"Clinical Study"},{"pmid":"41886245","year":"2026","title":"Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Receiving Teclistamab: A Panel Chart Review Study.","finding":"","journal":"Oncology and therapy","studyType":"Clinical Study"},{"pmid":"41886220","year":"2026","title":"Revised Recommendations for Restarting Teclistamab Following Dose Delays: Insights from the MajesTEC-1 Study on Clinical Safety, and from Simulated Pharmacokinetics and Cytokine Dynamics.","finding":"","journal":"Targeted oncology","studyType":"Clinical Study"},{"pmid":"41882240","year":"2026","title":"Recurrent cytokine release syndrome in patients receiving bispecific antibody therapy for multiple myeloma: a case series.","finding":"","journal":"Annals of hematology","studyType":"Clinical Study"},{"pmid":"41881461","year":"2026","title":"Outpatient Delivery of Step-Up Doses to Rapidly Initiate Monthly Doses of Bispecific Antibodies in Multiple Myeloma.","finding":"","journal":"European journal of haematology","studyType":"Clinical Study"}],"_fda":{"id":"12c44850-5938-4946-b1c1-8f97e9224f14","set_id":"54e0f974-ccee-44ea-9254-40e9883cee1e","openfda":{"unii":["54534MX6Z9"],"route":["SUBCUTANEOUS"],"rxcui":["2619432","2619438","2619441","2619444"],"spl_id":["12c44850-5938-4946-b1c1-8f97e9224f14"],"brand_name":["TECVAYLI"],"spl_set_id":["54e0f974-ccee-44ea-9254-40e9883cee1e"],"package_ndc":["57894-449-01","57894-450-01"],"product_ndc":["57894-449","57894-450"],"generic_name":["TECLISTAMAB-CQYV"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["TECLISTAMAB"],"manufacturer_name":["Janssen Biotech, Inc."],"application_number":["BLA761291"],"is_original_packager":[true]},"version":"15","pregnancy":["8.1 Pregnancy Risk Summary Based on the mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TECVAYLI in pregnant patients to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. TECVAYLI is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with TECVAYLI should be considered. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively."],"description":["11 DESCRIPTION Teclistamab-cqyv, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) antibody. Teclistamab-cqyv is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. Teclistamab-cqyv consists of an anti-BCMA heavy chain and light chain and an anti-CD3 heavy chain and light chain with two interchain disulfide bonds connecting the two arms. The molecular weight of teclistamab-cqyv is approximately 146 kDa. TECVAYLI ® (teclistamab-cqyv) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to light yellow solution supplied in a single-dose vial for subcutaneous administration. Each TECVAYLI 3 mL single-dose vial contains 30 mg of teclistamab-cqyv, edetate disodium (0.054 mg), glacial acetic acid (0.72 mg), polysorbate 20 (1.2 mg), sodium acetate (2.7 mg), sucrose (240 mg), and Water for Injection, USP. Each TECVAYLI 1.7 mL single-dose vial contains 153 mg of teclistamab-cqyv, edetate disodium (0.031 mg), glacial acetic acid (0.41 mg), polysorbate 20 (0.68 mg), sodium acetate (1.5 mg), sucrose (140 mg), and Water for Injection, USP."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING TECVAYLI ® (teclistamab-cqyv) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to light yellow solution supplied as follows: One 30 mg/3 mL (10 mg/mL) single-dose vial in a carton: NDC: 57894-449-01 One 153 mg/1.7 mL (90 mg/mL) single-dose vial in a carton: NDC: 57894-450-01 Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze."],"spl_medguide":["This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: Mar 2026 MEDICATION GUIDE TECVAYLI ® [tek vay lee] (teclistamab-cqyv) injection, for subcutaneous use What is the most important information I should know about TECVAYLI? TECVAYLI can cause side effects that are serious, life-threatening or cause death, including cytokine release syndrome (CRS) and neurologic problems. Cytokine Release Syndrome (CRS). Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: fever (100.4 °F or higher) difficulty breathing chills dizziness or lightheadedness fast heartbeat feeling anxious confusion or restlessness headache increased liver enzymes in your blood. See \" What are the possible side effects of TECVAYLI? \" for information about the signs and symptoms of liver problems. Due to the risk of CRS, you will receive TECVAYLI on a \"step-up dosing\" schedule. You should be hospitalized for 48 hours after the first and second step-up doses and should stay close to a healthcare facility and be monitored by a healthcare provider for 48 hours after you receive your first treatment dose. During the step-up dosing schedule your TECVAYLI dose will be increased for the first 3 doses. You will receive: a smaller step-up dose as your first dose on day 1 of treatment an increased step-up dose as your second dose, usually around day 3 or 4 of treatment an increased dose as your first treatment dose, usually around day 7 of treatment Your healthcare provider will decide the number of days to wait between your doses of TECVAYLI and how many treatments you will receive. If your dose of TECVAYLI is delayed for any reason, you may need to repeat the step-up dosing schedule. Before each step-up dose and your first treatment dose of TECVAYLI you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines with future doses. Neurologic problems. Tell your healthcare provider or get medical help right away if you develop any signs and symptoms of neurologic problems, including: headache jerking movements rigid muscles feeling restless numbness and tingling (feeling like \"pins and needles\") feeling less alert feeling disorientated, confused, or seeing or hearing things that are not real (hallucinations) trouble speaking muscle spasms tremor double vision changes in your handwriting problems walking muscle weakness in your body or face burning, throbbing, or stabbing pain feeling sleepy memory problems Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with TECVAYLI and treat you as needed. Your healthcare provider may temporarily stop or completely stop your treatment with TECVAYLI if you develop CRS or neurologic problems. TECVAYLI is available only through the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems. You will receive a Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital. If you have any questions about TECVAYLI, ask your healthcare provider. See \" What are the possible side effects of TECVAYLI? \" for more information about side effects. What is TECVAYLI? TECVAYLI is a prescription medicine used to treat adults with multiple myeloma that has come back or did not respond to prior treatment: in combination with daratumumab and hyaluronidase-fihj in people who have received at least 1 treatment regimen, including a proteasome inhibitor and an immunomodulatory agent. alone in people who have received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. It is not known if TECVAYLI is safe and effective in children. Before you receive TECVAYLI, tell your healthcare provider about all of your medical conditions, including if you: have an infection are pregnant or plan to become pregnant. TECVAYLI may harm your unborn baby. Your healthcare provider should do a pregnancy test before you start treatment with TECVAYLI. You should use effective birth control (contraception) during treatment and for 5 months after your last dose of TECVAYLI. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with TECVAYLI. are breastfeeding or plan to breastfeed. It is not known if TECVAYLI passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of TECVAYLI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive TECVAYLI? TECVAYLI will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen), your thigh or another area of your body may be injected. See \" What is the most important information I should know \" at the beginning of this Medication Guide for information about how you will receive TECVAYLI. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with TECVAYLI. What should I avoid while receiving TECVAYLI? Do not drive or operate heavy or dangerous machinery during and for 48 hours after your TECVAYLI step-up dosing schedule is completed, or at any time during treatment with TECVAYLI if you develop new neurologic symptoms such as dizziness, confusion, tremors, sleepiness, or any other symptoms that impair your consciousness, until the symptoms go away. See \" What is the most important information I should know about TECVAYLI? \" for more information about signs and symptoms of neurologic problems. What are the possible side effects of TECVAYLI? TECVAYLI can cause serious side effects, including: See \" What is the most important information I should know about TECVAYLI? \" Liver problems . TECVAYLI can cause liver problems that may cause death. Increases in liver enzymes can happen with or without CRS. Tell your healthcare provider right away if you develop any symptoms of a liver problem including: tiredness loss of appetite pain in your right upper stomach-area (abdomen) dark urine yellowing of your skin or white part of your eyes Infections. TECVAYLI can cause bacterial and viral infections that are severe, life-threatening, or that may cause death. Your healthcare provider may prescribe medicines to help prevent infections and treat you as needed if you develop an infection during treatment with TECVAYLI. Tell your healthcare provider right away if you get a fever, chills or any signs or symptoms of an infection. Decreased white blood cell counts. Fever sometimes also happens with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed. Allergic reactions and injection site reactions. Allergic reactions : can include fever, rash, swollen tongue, or trouble breathing. Get medical help right away if you develop any symptoms of an allergic reaction during treatment with TECVAYLI. Injection site reactions: can include redness, heat, swelling, bruising, bacterial skin infection (cellulitis), discomfort, blood collection under the skin at the injection site (hematoma), and rash. Tell your healthcare provider if you develop any severe injection site reactions. Your healthcare provider will check your liver enzymes and white blood cell counts before you start and during treatment with TECVAYLI. Your healthcare provider will monitor you for signs and symptoms of these serious side effects during treatment and may temporarily or permanently stop TECVAYLI if you develop severe side effects. The most common side effects of TECVAYLI when used alone include: fever CRS muscle, joint, and bone pain injection site reaction tiredness upper respiratory tract infection nausea headache pneumonia diarrhea The most common side effects of TECVAYLI when used with daratumumab and hyaluronidase-fihj include: low blood levels of antibodies called immunoglobins upper respiratory tract infection CRS cough diarrhea muscle, joint, and bone pain COVID-19 pneumonia injection site reaction tiredness fever headache nausea stomach area pain or cramps decreased weight The most common severe abnormal blood test results with TECVAYLI include: decreased white blood cells, red blood cells, and platelets. These are not all the possible side effects of TECVAYLI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General Information about the safe and effective use of TECVAYLI. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about TECVAYLI that is written for health professionals. What are the ingredients in TECVAYLI? Active ingredient : teclistamab-cqyv Inactive ingredients : edetate disodium, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA U.S. License Number 1864 For patent information: www.janssenpatents.com © Johnson & Johnson and its affiliates 2022, 2026 For more information about TECVAYLI go to www.TECVAYLI.com or call 1-800-526-7736."],"boxed_warning":["WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )"],"geriatric_use":["8.5 Geriatric Use Of the 165 patients with relapsed or refractory multiple myeloma treated with TECVAYLI in MajesTEC-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness. Of the 291 patients with relapsed or refractory multiple myeloma treated with TECVAYLI at the recommended dosage in combination with daratumumab and hyaluronidase-fihj in MajesTEC-3, 51% were younger than 65 years of age, 39% were 65 to 74 years of age, and 11% were 75 years of age or older. No overall differences in effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in effectiveness compared to younger patients. There was a higher incidence of serious adverse reactions in patients 75 years of age or older (83%) and in patients 65 to 74 years of age (77%) as compared to patients younger than 65 years of age (63%)."],"pediatric_use":["8.4 Pediatric Use The safety and efficacy of TECVAYLI have not been established in pediatric patients."],"effective_time":"20260310","clinical_studies":["14 CLINICAL STUDIES 14.1 Relapsed or Refractory Multiple Myeloma In Combination with Daratumumab and Hyaluronidase - fihj The efficacy of TECVAYLI in combination with subcutaneous daratumumab and hyaluronidase-fihj compared with investigator's choice of either daratumumab and hyaluronidase-fihj, pomalidomide and dexamethasone (DPd) or daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) was evaluated in adult patients with relapsed or refractory multiple myeloma in a randomized, open-label, multi-center study (MajesTEC-3) (NCT05083169). The study included patients who had previously received one to three prior lines of therapy including a proteasome inhibitor and lenalidomide. Patients who had received only one prior line of therapy must have been refractory to lenalidomide. Patients who had disease refractory to a prior anti-CD38 monoclonal antibody therapy, or who had received any prior BCMA-directed therapy were excluded. Patients received TECVAYLI in combination with daratumumab and hyaluronidase-fihj as follows: Subcutaneous TECVAYLI step-up doses of 0.06 mg/kg and 0.3 mg/kg, followed by TECVAYLI 1.5 mg/kg once weekly from Weeks 2 to 8, then 3 mg/kg every two weeks from Weeks 9 to 24, then 3 mg/kg every four weeks starting on Week 25 until disease progression or unacceptable toxicity, AND Subcutaneous daratumumab and hyaluronidase-fihj 1,800 mg/30,000 units (1,800 mg of daratumumab and 30,000 units of hyaluronidase) starting one day prior to TECVAYLI and continuing once weekly from Weeks 1 to 8, then every two weeks from Weeks 9 to 24, then every four weeks starting on Week 25 until disease progression or unacceptable toxicity [see Dosage and Administration (2.2) ] . The major efficacy outcome measure was progression-free survival (PFS) by Independent Review Committee (IRC) assessment based on International Myeloma Working Group (IMWG) 2016 criteria. A total of 587 patients were randomized in MajesTEC-3: 291 to the TECVAYLI in combination with daratumumab and hyaluronidase-fihj group and 296 to the control group (DPd or DVd). The median age was 64 years (range: 25 to 88) with 38% aged 65 to 74 years and 10% aged 75 years or older; 55% were male; 65% were White, 6% were Black or African American, and 22% were Asian. The International Staging System (ISS) at screening was stage I in 63%, stage II in 29%, and stage III in 8%. High-risk cytogenetics (presence of del(17p), t(4;14) or t(14;16)) were present in 35% of patients. Extramedullary disease was present in 5% of patients. The median number of prior lines of therapy was 2 (range: 1 to 3), with 38% who received one prior line of therapy. All patients received prior lenalidomide and 99.8% received a prior proteasome inhibitor; 84% were refractory to lenalidomide. Seventy-four percent of patients previously received autologous stem cell transplantation. Five percent of patients received a prior anti-CD38 monoclonal antibody; there is limited data with TECVAYLI in combination with daratumumab and hyaluronidase-fihj in patients who have received or are refractory to prior anti-CD38 monoclonal antibody therapy. The trial demonstrated a statistically significant improvement in the TECVAYLI in combination with daratumumab and hyaluronidase-fihj group compared with the control group in PFS and overall survival (OS). The efficacy results are shown in Table 17 and Figures 1 and 2. Table 17: Efficacy Results (MajesTEC-3) TECVAYLI with daratumumab and hyaluronidase-fihj (N=291) DPd or DVd (N=296) DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone; CI=confidence interval; NE=not estimable; NR=not reached; MRD = minimal residual disease. Progression-free survival (PFS) Based on intent-to-treat analysis set , Median duration of follow-up = 34.5 months Number of events, n (%) 44 (15) 187 (63) Median, months (95% CI) NR (NE, NE) 18.1 (14.6, 22.8) Hazard ratio (95% CI) Stratified Cox proportional hazard model. For all stratified analyses, stratification was based on ISS staging (I vs. II or III) and number of prior lines of therapy (1 vs. 2 or 3), as randomized ; p-value Stratified log-rank test 0.17 (0.12, 0.23); <0.0001 Overall survival (OS) , Number of events, n (%) 46 (16) 98 (33) Median, months (95% CI) NR (NE, NE) NR (41.4, NE) Hazard ratio (95% CI) ; p-value 0.46 (0.32, 0.65); <0.0001 Overall response (sCR+CR+VGPR+PR) , n (%) 259 (89.0) 223 (75.3) 95% CI (%) (84.8, 92.4) (70.0, 80.1) p-value Stratified Cochran Mantel-Haenszel Chi-Squared test <0.0001 Stringent complete response (sCR), n (%) 225 (77.3) 69 (23.3) Complete response (CR), n (%) 13 (4.5) 26 (8.8) Very good partial response (VGPR), n (%) 14 (4.8) 74 (25.0) Partial response (PR), n (%) 7 (2.4) 54 (18.2) Complete response or better (sCR+CR) , n (%) 238 (81.8) 95 (32.1) 95% CI (%) (76.9, 86.0) (26.8, 37.7) p-value <0.0001 MRD negativity rate Based on MRD next-generation sequencing (NGS) primary analysis set, defined as all randomized patients enrolled at sites where next generation sequencing assay was available. , Based on a threshold of 10 -5 using a next generation sequencing assay (clonoSEQ). , N 262 269 n (%) 153 (58.4) 46 (17.1) 95% CI (%) (52.2, 64.4) (12.8, 22.1) p-value Fisher's exact test <0.0001 MRD negativity rate in patients with CR or better Number of patients with CR or better, n 216 86 MRD negativity rate, n (%) 153 (70.8) 46 (53.5) 95% CI (%) (64.3, 76.8) (42.4, 64.3) Figure 1: Kaplan-Meier Curve of PFS (MajesTEC-3) Tec-Dara = TECVAYLI in combination with daratumumab and hyaluronidase-fihj; DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone. Figure 2: Kaplan-Meier Curve of OS (MajesTEC-3) Tec-Dara = TECVAYLI in combination with daratumumab and hyaluronidase-fihj; DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone. In the 15 patients in MajesTEC-3 who had received a prior anti-CD38 monoclonal antibody, the ORR was 93.3% (95% CI: 68.1, 99.8). Monotherapy The efficacy of TECVAYLI was evaluated in patients with relapsed or refractory multiple myeloma in a single-arm, open-label, multi-center study (MajesTEC-1, NCT03145181 [Phase 1] and NCT04557098 [Phase 2]). The study included patients who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The study excluded patients who had stroke, seizure, allogeneic stem cell transplantation within the past 6 months, Eastern Cooperative Oncology Group (ECOG) performance score of 2 or higher, known active CNS involvement or clinical signs of meningeal involvement of multiple myeloma, or active or documented history of autoimmune disease, with the exception of vitiligo, Type 1 diabetes, and prior autoimmune thyroiditis. Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI 1.5 mg/kg subcutaneously once weekly thereafter until disease progression or unacceptable toxicity [see Dosage and Administration (2.2) ] . The efficacy population included 110 patients. The median age was 66 (range: 33 to 82) years with 16% of patients 75 years of age or older; 56% were male; 91% were White, 5% were Black or African American, 3% were Asian. The International Staging System (ISS) at study entry was Stage I in 50%, Stage II in 38%, and Stage III in 12% of patients. High-risk cytogenetics (presence of del(17p), t(4;14) or t(14;16)) were present in 25% of patients. Seventeen percent of patients had extramedullary plasmacytomas. Patients with prior BCMA-targeted therapy were not included in the efficacy population. The median number of prior lines of therapy was 5 (range: 2 to 14); 78% of patients had received at least 4 prior lines of therapy. Eighty-one percent of patients received prior stem cell transplantation. All patients had received prior therapy with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and 76% were triple-class refractory (refractory to a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody). Efficacy was established based on overall response rate (ORR) as determined by the Independent Review Committee (IRC) assessment using International Myeloma Working Group (IMWG) 2016 criteria (see Table 18 ). The median time to first response was 1.2 months (range: 0.2 to 5.5 months). With a median follow-up of 7.4 months among responders, the estimated duration of response (DOR) rate was 90.6% (95% CI: 80.3%, 95.7%) at 6 months and 66.5% (95% CI: 38.8%, 83.9%) at 9 months. Table 18: Efficacy Results for MajesTEC-1 N=110 NE=not estimable Overall response rate (ORR: sCR+CR+VGPR+PR) n (%) 68 (61.8) 95% CI (%) (52.1, 70.9) Complete response (CR) or better Complete response or better = Stringent complete response (sCR) + complete response (CR). 31 (28.2) Very good partial response (VGPR) 32 (29.1) Partial response (PR) 5 (4.5) Duration of Response (DOR) (months) DOR (Months): Median (95% CI) NE (9.0, NE) Figure 1 Figure 2"],"pharmacodynamics":["12.2 Pharmacodynamics Serum concentrations of cytokines (IL-6, IL-10, TNF-α, and IFN-γ) and IL-2R were measured before and after administration of step-up dose 1, step-up dose 2, and the three weekly doses of 1.5 mg/kg of TECVAYLI. Increased concentrations of IL-6, IL-10, and IL-2R were observed during this period."],"pharmacokinetics":["12.3 Pharmacokinetics The C max and C avg of teclistamab-cqyv after the first subcutaneous 1.5 mg/kg TECVAYLI dose increase proportionally over a dosage range of 0.08 mg/kg to 3 mg/kg in monotherapy (0.05 to 2 times the approved recommended treatment dosage). Following the recommended dosage of TECVAYLI monotherapy, 90% of steady state exposure was achieved after 12 weekly TECVAYLI doses (1.5 mg/kg once weekly). The mean accumulation ratio between the first and 13 th weekly dose of TECVAYLI 1.5 mg/kg was 4.2-fold for C max , 4.1-fold for C trough , and 5.3-fold for C avg . The pharmacokinetic characteristics of teclistamab-cqyv were consistent whether used as monotherapy or in combination with daratumumab and hyaluronidase-fihj. The C max , C trough , and C avg of teclistamab-cqyv are presented in Table 16. Table 16: Pharmacokinetic Parameters of Teclistamab-cqyv After Administration of the Recommended Dose in Patients with Relapsed or Refractory Multiple Myeloma C max (µg/mL) C trough (µg/mL) C avg (µg/mL) C avg =average serum teclistamab-cqyv concentration over a dosing interval; C max =maximum serum teclistamab-cqyv concentration; C trough =serum teclistamab-cqyv concentration prior to next dose Note: Data are presented as geometric mean (CV %). TECVAYLI Monotherapy First 1.5 mg/kg dose 6.34 (60%) 5.77 (63%) 4.98 (61%) Steady state of 1.5 mg/kg weekly dosing steady-state exposure for the 13 th weekly dose. 23.8 (55%) 21.1 (63%) 22.8 (57%) TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj First 1.5 mg/kg dose 6.36 (54%) 5.79 (59%) 4.96 (55%) End of 1.5 mg/kg weekly dosing exposure for the 7 th weekly dose. 19.6 (54%) 17.3 (62%) 18.6 (56%) End of 3 mg/kg every two weeks dosing exposure for the 8 th every two weeks dose. 29.9 (55%) 19.8 (85%) 26.2 (62%) Steady state of 3 mg/kg every 4 weeks dosing steady-state exposure for the 5 th Q4W dose. 20.2 (52%) 5.82 (152%) 13.7 (67%) Absorption The mean bioavailability of teclistamab-cqyv was 72% after subcutaneous administration of TECVAYLI. The median (range) T max of teclistamab-cqyv after the first and 13 th TECVAYLI monotherapy treatment doses were 139 (19 to 168) hours and 72 (24 to 168) hours, respectively. Distribution The mean (coefficient of variation [CV]%) volume of distribution of teclistamab-cqyv was 5.63 L (29%). Elimination Teclistamab-cqyv clearance decreases over time, with a mean (CV%) maximal reduction from baseline to the 13 th weekly TECVAYLI monotherapy treatment dose of 40.8% (56%). The geometric mean (CV%) clearance is 0.472 L/day (64%) at the 13 th weekly TECVAYLI monotherapy treatment dose. Patients who discontinue TECVAYLI after the 13 th weekly monotherapy treatment dose are expected to have a 50% reduction from C max in teclistamab-cqyv concentration at a median (5 th to 95 th percentile) time of 15 days (7 to 33 days) after T max and a 97% reduction from C max in teclistamab-cqyv concentration at a median time of 69 days (32 to 163 days) after T max . Specific Populations There were no clinically significant differences in the exposure of teclistamab-cqyv based on age (24 to 84 years), sex, race (White, Black or African American), ethnicity (Hispanic/Latino, not Hispanic/Latino), mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] by Modification of Diet in Renal Disease [MDRD] method: 30 to 89 mL/minute), or mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). The effects of severe renal impairment (eGFR less than 30 mL/minute) or moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN with any AST) on the exposures of teclistamab-cqyv are unknown. Body Weight The volume of distribution and clearance of teclistamab-cqyv increase with increasing body weight (37.6 kg to 164 kg), supporting a weight-based dose. Drug Interaction Studies No clinical studies evaluating the drug interaction potential of teclistamab-cqyv have been conducted."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are also described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity including ICANS [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Infections [see Warnings and Precautions (5.5) ] Neutropenia [see Warnings and Precautions (5.6) ] Hypersensitivity and Other Administration Reactions [see Warnings and Precautions (5.7) ] The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy are pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. ( 6.1 ) The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj are hypogammaglobulinemia, upper respiratory tract infection, cytokine release syndrome, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis and weight decreased. ( 6.1 ) The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) are decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed/Refractory Multiple Myeloma In Combination with Daratumumab and Hyaluronidase-fihj The safety of TECVAYLI in combination with daratumumab and hyaluronidase-fihj (N=283) compared with either daratumumab and hyaluronidase-fihj, pomalidomide and dexamethasone (DPd) or daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) (N=290) was evaluated in patients with relapsed or refractory multiple myeloma in MajesTEC-3 [see Clinical Studies (14.1) ] . Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI 1.5 mg/kg once weekly, followed by TECVAYLI 3 mg/kg every two weeks, followed by TECVAYLI 3 mg/kg every four weeks, subcutaneously. Among patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj the median exposure was 32 (range 0.03 to 43) months. Among patients who received DPd or DVd the median exposure was 16 (range 0.03 to 45) months. Serious adverse reactions occurred in 71% of patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj. Serious adverse reactions reported in ≥3% of patients included pneumonia (33%), upper respiratory tract infection (15%), cytokine release syndrome (10%), COVID-19 (7%), sepsis (6%), second primary malignancy (5%), pyrexia (4.9%), febrile neutropenia (4.6%), and gastroenteritis (4.2%). Fatal adverse reactions occurred in 2.5% of patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj, and included sepsis (0.7%), pneumonia (0.4%), sudden death (0.4%), myocardial infarction (0.4%), enterovirus myocarditis (0.4%) and hemophagocytic lymphohistiocytosis (0.4%). Permanent discontinuation of TECVAYLI due to adverse reactions occurred in 6% of patients. Adverse reactions leading to discontinuation of TECVAYLI in more than one patient were pneumonia (1.1%), diarrhea (0.7%), fatigue (0.7%), second primary malignancy (0.7%), upper respiratory tract infection (0.7%) and cough (0.7%). Dosage interruptions of TECVAYLI due to an adverse reaction occurred in 94% of patients. Adverse reactions which required dosage interruption of TECVAYLI in ≥5% of patients included neutropenia (53%), upper respiratory tract infection (48%), COVID-19 (34%), pneumonia (34%), thrombocytopenia (14%), cytokine release syndrome (13%), gastroenteritis (10%), cough (10%), pyrexia (8%), diarrhea (7%), sepsis (6%) and fatigue (5%). The most common adverse reactions (≥20%) were hypogammaglobulinemia, upper respiratory tract infection, cytokine release syndrome, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells and decreased platelets. Table 12 summarizes the adverse reactions in MajesTEC-3. Table 12: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3 Adverse Reaction TECVAYLI with daratumumab and hyaluronidase-fihj (N=283) DPd or DVd (N=290) Any Grade (%) Grade 3 or 4 (%) Any Grade (%) Grade 3 or 4 (%) DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone. Adverse reactions were graded according to NCI-CTCAE Version 5.0, with the exception of ICANS and CRS, which were graded by ASTCT 2019 consensus grading system; adverse reactions that were considered symptoms of CRS or ICANS were not included. Immune system disorders Hypogammaglobulinemia Hypogammaglobulinemia includes hypogammaglobulinemia, hypoglobulinemia; and/or patients with laboratory IgG levels below 400 mg/dL following treatment with TECVAYLI. 84 6 60 1.4 Cytokine release syndrome 60 0 0 0 Infections Upper respiratory tract infection Upper respiratory tract infection includes bronchitis, bronchiolitis, pharyngitis, rhinitis, sinusitis, sinobronchitis, tracheitis, and tracheobronchitis and other related terms. 79 17 62 13 COVID-19 Includes other related terms. 45 6 33 2.1 Pneumonia Pneumonia includes atypical pneumonia, bacterial pneumonia, fungal pneumonia, viral pneumonia, and other related terms. Includes the following fatal adverse reactions: Tec-Dara: Pneumonia (n=1); DPd/DVd: Pneumonia (n=2). 42 33 35 28 Gastroenteritis 20 4.9 8 0.7 Urinary tract infection 17 2.8 13 1 Herpes virus infection 11 2.1 6 0.3 Respiratory, thoracic and mediastinal disorders Cough 53 0.7 24 0 Dyspnea 13 1.8 20 2.1 Gastrointestinal disorders Diarrhea 52 3.9 31 2.4 Nausea 23 0 12 0.3 Vomiting 17 0 7 0 Abdominal pain 16 0.7 13 0 Constipation 14 0 20 0.3 Musculoskeletal and connective tissue disorders Musculoskeletal pain 50 1.4 47 4.5 General disorders and administration site conditions Injection site reaction Includes injection site reactions related to teclistamab, daratumumab and hyaluronidase-fihj, or bortezomib. 41 0 4.5 0 Fatigue 39 3.9 40 4.1 Pyrexia 37 1.4 19 0.3 Edema 13 0.4 22 0.3 Nervous system disorders Headache 26 1.4 12 0.3 Sensory neuropathy Sensory neuropathy includes dysaesthesia, hyperaesthesia, hypoaesthesia, paraesthesia, neuralgia, peripheral neuropathy, polyneuropathy, sciatica and other related terms. 17 0.7 25 0.3 Motor dysfunction Motor dysfunction includes balance disorder, dysarthria, dysphonia, gait disturbance, muscle contracture, muscle spasms, muscle spasticity, muscle twitching, muscular weakness, myopathy, peripheral motor neuropathy, tremor and other related terms. 14 0 30 1 Investigations Weight decreased 20 2.8 7 1.4 Metabolism and nutrition disorders Decreased appetite 19 1.1 7 0 Cardiac disorders Cardiac arrhythmia 11 1.1 8 2.1 Neoplasms Second primary malignancy 11 4.6 9 4.8 Vascular disorders Hypertension 11 4.6 6 2.4 Clinically relevant adverse reactions in <10% of patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj included sepsis, encephalopathy, CMV infection, febrile neutropenia and ICANS. Table 13 summarizes laboratory abnormalities in MajesTEC-3. Table 13: Select Laboratory Abnormalities (≥30%) that Worsened from Baseline in Patients with Multiple Myeloma who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3 Laboratory Abnormality TECVAYLI with daratumumab and hyaluronidase-fihj (N=283) DPd or DVd (N=290) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone. Percentages calculated with the number of subjects with a baseline and at least one post-treatment value for each lab test as denominator. Laboratory toxicity grades are derived based on NCI CTCAE Version 5.0. The denominator used to calculate the incidence varied from 137 to 282 in Tec-Dara and 135 to 289 in DPd/DVd based on the number of patients with a baseline value and at least one post-treatment value. Hematology Lymphocyte Count Decreased 99 95 93 64 White Blood Cell Decreased 94 60 96 74 Neutrophil Count Decreased 91 78 94 84 Platelet Count Decreased 73 21 72 25 Hemoglobin Decreased 64 17 61 19 Chemistry Alanine Aminotransferase Increased 60 5 33 2.4 Aspartate Aminotransferase Increased 55 3.9 22 1.7 Potassium Decreased 52 15 35 8 GGT Increased 51 5 24 0 Sodium Decreased 46 10 37 6 Lipase Increased 49 18 21 4.7 Serum Amylase Increased 31 7 13 0 Monotherapy The safety of TECVAYLI monotherapy (N=165) in patients with relapsed or refractory multiple myeloma was evaluated in MajesTEC-1 [see Clinical Studies (14.1) ] . Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI 1.5 mg/kg, subcutaneously once weekly. Among patients who received TECVAYLI, 47% were exposed for 6 months or longer and 7% were exposed for one year or longer. The median age of patients who received TECVAYLI was 64 years (range: 33 to 84 years); 58% were male; 81% were White, 13% were Black or African American, and 2% were Asian. Serious adverse reactions occurred in 54% of patients who received TECVAYLI. Serious adverse reactions in >2% of patients included pneumonia (15%), cytokine release syndrome (8%), sepsis (6%), general physical health deterioration (6%), COVID-19 (6%), acute kidney injury (4.8%), pyrexia (4.8%), musculoskeletal pain (2.4%), and encephalopathy (2.4%). Fatal adverse reactions occurred in 5% of patients who received TECVAYLI, including COVID-19 (1.8%), pneumonia (1.8%), septic shock (0.6%), acute renal failure (0.6%), and hemoperitoneum (0.6%). Permanent discontinuation of TECVAYLI due to adverse reactions occurred in 1.2% of patients. Adverse reactions resulting in permanent discontinuation of TECVAYLI included pneumonia (adenoviral and pneumocystis jirovecii pneumonia in the same patient) and hypercalcemia. Dosage interruptions of TECVAYLI due to an adverse reaction occurred in 73% of patients. Adverse reactions which required dosage interruption in >5% of patients included neutropenia, pneumonia, pyrexia, cytokine release syndrome, upper respiratory tract infection, and COVID-19. The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Table 14 summarizes the adverse reactions in MajesTEC-1. Table 14: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received TECVAYLI in MajesTEC-1 Adverse Reactions TECVAYLI (N=165) Any Grade (%) Grade 3 or 4 (%) Adverse reactions were graded based on NCI-CTCAE Version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria. General disorders and administration site conditions Pyrexia 76 3 Only grade 3 adverse reactions occurred. Injection site reaction Includes other related terms. 37 0.6 Fatigue 33 2.4 Chills 16 0 Pain 15 1.8 Edema 13 0 Immune system disorders Cytokine release syndrome 72 0.6 Hypogammaglobulinemia Hypogammaglobulinemia includes hypogammaglobulinemia and hypoglobulinemia. 11 1.2 Musculoskeletal and connective tissue disorders Musculoskeletal pain 44 4.2 Bone pain 16 3 Infections Upper respiratory tract infection Upper respiratory tract infection includes bronchitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, tracheitis and other related terms. 26 2.4 Pneumonia Pneumonia includes bacterial pneumonia, viral pneumonia, and other related terms. Includes the following fatal adverse reactions: hemorrhage (n=1), pneumonia (n=3). 24 15 Urinary tract infection 11 5 Gastrointestinal disorders Nausea 25 0.6 Diarrhea 21 2.4 Constipation 18 0 Vomiting 12 0.6 Nervous system disorders Headache 25 0.6 Motor dysfunction Motor dysfunction includes cogwheel rigidity, dysgraphia, dysphonia, gait disturbance, hypokinesia, muscle rigidity, muscle spasms, muscular weakness, peroneal nerve palsy, psychomotor hyperactivity, tremor and VI th nerve paralysis. 16 0 Sensory neuropathy Sensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis. 15 1.2 Encephalopathy Encephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence. 13 0 Vascular disorders Hypotension 18 1.2 Hemorrhage 12 1.8 Hypertension 12 4.8 Respiratory, thoracic, and mediastinal disorders Hypoxia 18 1.8 Cough 15 0 Cardiac disorders Cardiac arrhythmia 16 1.8 Metabolism and nutrition disorders Decreased appetite 11 0.6 Renal and urinary disorders Acute kidney injury 11 3.6 Clinically relevant adverse reactions in <10% of patients who received TECVAYLI included febrile neutropenia, sepsis, ICANS, seizure, Guillain-Barré syndrome, hepatic failure, and new onset or reactivated viral infections (including adenovirus, hepatitis B virus (HBV), cytomegalovirus (CMV), varicella zoster virus (VZV), herpes simplex virus (HSV), and progressive multifocal leukoencephalopathy (PML). Table 15 summarizes laboratory abnormalities in MajesTEC-1. Table 15: Select Laboratory Abnormalities (≥30%) That Worsened from Baseline in TECVAYLI Treated Patients with Multiple Myeloma in MajesTEC-1 Laboratory Abnormality TECVAYLI (N=165 The denominator used to calculate the rate varied from 164 to 165 based on the number of patients with a baseline value and at least one post-treatment value. ) All Grades (%) Grade 3 or 4 (%) Laboratory toxicity grades are derived based on NCI CTCAE Version 4.03. Hematology Lymphocyte count decreased 92 84 White blood cell decreased 86 41 Neutrophil count decreased 84 56 Platelet count decreased 71 22 Hemoglobin decreased 67 33 Chemistry Albumin decreased 68 6 Alkaline phosphatase increased 42 2.4 Phosphorus decreased 38 13 Gamma-glutamyl transferase increased 37 8 Sodium decreased 35 10 Aspartate aminotransferase increased 34 1.2 Calcium (corrected) decreased 31 1.2 Creatinine increased 30 3"],"contraindications":["4 CONTRAINDICATIONS None. None. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS TECVAYLI causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of certain cytochrome P450 (CYP) enzymes, resulting in increased exposure of CYP substrates, which may increase the risk of adverse reactions of the CYP substrates. The highest risk of drug-drug interaction is expected to occur after initiation of TECVAYLI step-up dosing schedule up to 7 days after the first treatment dose and during and after CRS [see Warnings and Precautions (5.1) ] . Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate as needed. Certain CYP Substrates : Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate, as needed ( 7 )."],"spl_medguide_table":["<table width=\"100%\"><col width=\"2%\" align=\"left\" valign=\"top\"/><col width=\"32%\" align=\"left\" valign=\"top\"/><col width=\"33%\" align=\"left\" valign=\"top\"/><col width=\"33%\" align=\"left\" valign=\"top\"/><tfoot><tr><td align=\"left\" colspan=\"3\">This Medication Guide has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\">Revised: Mar 2026</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\" align=\"center\"><content styleCode=\"bold\">MEDICATION GUIDE   TECVAYLI<sup>&#xAE;</sup> [tek vay lee]   (teclistamab-cqyv) injection, for subcutaneous use</content></td></tr><tr><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content ID=\"important\" styleCode=\"bold\">What is the most important information I should know about TECVAYLI?</content>  TECVAYLI can cause side effects that are serious, life-threatening or cause death, including cytokine release syndrome (CRS) and neurologic problems. <list listType=\"unordered\" styleCode=\"circle\"><item><content styleCode=\"bold\">Cytokine Release Syndrome (CRS).</content> Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:</item></list></td></tr><tr><td styleCode=\"Lrule\"/><td><list listType=\"unordered\" styleCode=\"circle\"><item>fever (100.4 &#xB0;F or higher)</item><item>difficulty breathing</item><item>chills</item><item>dizziness or lightheadedness</item><item>fast heartbeat</item></list></td><td styleCode=\"Rrule\" colspan=\"2\"><list listType=\"unordered\" styleCode=\"circle\"><item>feeling anxious</item><item>confusion or restlessness</item><item>headache</item><item>increased liver enzymes in your blood. See &quot;<content styleCode=\"bold\"><linkHtml href=\"#sideeffects\">What are the possible side effects of TECVAYLI?</linkHtml>&quot;</content> for information about the signs and symptoms of liver problems.</item></list></td></tr><tr><td styleCode=\"Lrule\"/><td styleCode=\"Rrule\" colspan=\"3\"><content styleCode=\"bold\">Due to the risk of CRS,</content> you will receive TECVAYLI on a &quot;step-up dosing&quot; schedule. You should be hospitalized for 48 hours after the first and second step-up doses and should stay close to a healthcare facility and be monitored by a healthcare provider for 48 hours after you receive your first treatment dose. <list listType=\"unordered\" styleCode=\"circle\"><item>During the step-up dosing schedule your TECVAYLI dose will be increased for the first 3 doses. You will receive: <list listType=\"unordered\" styleCode=\"square\"><item>a smaller step-up dose as your first dose on day 1 of treatment</item><item>an increased step-up dose as your second dose, usually around day 3 or 4 of treatment</item><item>an increased dose as your first treatment dose, usually around day 7 of treatment</item></list></item><item>Your healthcare provider will decide the number of days to wait between your doses of TECVAYLI and how many treatments you will receive.</item><item>If your dose of TECVAYLI is delayed for any reason, you may need to repeat the step-up dosing schedule.</item><item>Before each step-up dose and your first treatment dose of TECVAYLI you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines with future doses.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\" colspan=\"4\"><list listType=\"unordered\" styleCode=\"disc\"><item><content styleCode=\"bold\">Neurologic problems.</content> Tell your healthcare provider or get medical help right away if you develop any signs and symptoms of neurologic problems, including:</item></list></td></tr><tr><td styleCode=\"Lrule\"/><td><list listType=\"unordered\" styleCode=\"circle\"><item>headache</item><item>jerking movements</item><item>rigid muscles</item><item>feeling restless</item><item>numbness and tingling (feeling like &quot;pins and needles&quot;)</item><item>feeling less alert</item></list></td><td><list listType=\"unordered\" styleCode=\"circle\"><item>feeling disorientated, confused, or seeing or hearing things that are not real (hallucinations)</item><item>trouble speaking</item><item>muscle spasms</item><item>tremor</item><item>double vision</item></list></td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"circle\"><item>changes in your handwriting</item><item>problems walking</item><item>muscle weakness in your body or face</item><item>burning, throbbing, or stabbing pain</item><item>feeling sleepy</item><item>memory problems</item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\">Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with TECVAYLI and treat you as needed. Your healthcare provider may temporarily stop or completely stop your treatment with TECVAYLI if you develop CRS or neurologic problems. <list listType=\"unordered\" styleCode=\"disc\"><item><content styleCode=\"bold\">TECVAYLI is available only through the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.</content>  You will receive a Patient Wallet Card from your healthcare provider. <content styleCode=\"bold\">Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers.</content> The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.  <content styleCode=\"bold\">Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card.</content> You may need to be treated in a hospital.</item></list> If you have any questions about TECVAYLI, ask your healthcare provider.   See &quot;<content styleCode=\"bold\"><linkHtml href=\"#sideeffects\">What are the possible side effects of TECVAYLI?</linkHtml>&quot;</content> for more information about side effects.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">What is TECVAYLI?</content>  TECVAYLI is a prescription medicine used to treat adults with multiple myeloma that has come back or did not respond to prior treatment: <list listType=\"unordered\" styleCode=\"disc\"><item>in combination with daratumumab and hyaluronidase-fihj in people who have received at least 1 treatment regimen, including a proteasome inhibitor and an immunomodulatory agent.</item><item>alone in people who have received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.</item></list> It is not known if TECVAYLI is safe and effective in children.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">Before you receive TECVAYLI, tell your healthcare provider about all of your medical conditions, including if you:</content><list listType=\"unordered\" styleCode=\"disc\"><item>have an infection</item><item>are pregnant or plan to become pregnant. TECVAYLI may harm your unborn baby. <list listType=\"unordered\" styleCode=\"circle\"><item>Your healthcare provider should do a pregnancy test before you start treatment with TECVAYLI.</item><item>You should use effective birth control (contraception) during treatment and for 5 months after your last dose of TECVAYLI.</item><item>Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with TECVAYLI.</item></list></item><item>are breastfeeding or plan to breastfeed. It is not known if TECVAYLI passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of TECVAYLI.</item></list><content styleCode=\"bold\">Tell your healthcare provider about all the medicines you take,</content> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">How will I receive TECVAYLI?</content><list listType=\"unordered\" styleCode=\"disc\"><item>TECVAYLI will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen), your thigh or another area of your body may be injected.</item><item><content styleCode=\"bold\">See &quot;<linkHtml href=\"#important\">What is the most important information I should know</linkHtml>&quot; at the beginning of this Medication Guide for information about how you will receive TECVAYLI.</content></item><item>If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with TECVAYLI.</item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">What should I avoid while receiving TECVAYLI?</content> <content styleCode=\"bold\">Do not</content> drive or operate heavy or dangerous machinery during and for 48 hours after your TECVAYLI step-up dosing schedule is completed, or at any time during treatment with TECVAYLI if you develop new neurologic symptoms such as dizziness, confusion, tremors, sleepiness, or any other symptoms that impair your consciousness, until the symptoms go away. See <content styleCode=\"bold\">&quot;<linkHtml href=\"#important\">What is the most important information I should know about TECVAYLI?</linkHtml>&quot;</content> for more information about signs and symptoms of neurologic problems.</td></tr><tr><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content ID=\"sideeffects\" styleCode=\"bold\">What are the possible side effects of TECVAYLI?</content> <content styleCode=\"bold\">TECVAYLI can cause serious side effects, including:</content><list listType=\"unordered\" styleCode=\"disc\"><item>See <content styleCode=\"bold\">&quot;<linkHtml href=\"#important\">What is the most important information I should know about TECVAYLI?</linkHtml>&quot;</content></item><item><content styleCode=\"bold\">Liver problems</content>. TECVAYLI can cause liver problems that may cause death. Increases in liver enzymes can happen with or without CRS. <content styleCode=\"bold\">Tell your healthcare provider right away if you develop any symptoms of a liver problem including:</content></item></list></td></tr><tr><td styleCode=\"Lrule\"/><td><list listType=\"unordered\" styleCode=\"circle\"><item>tiredness</item><item>loss of appetite</item></list></td><td styleCode=\"Rrule\" colspan=\"2\"><list listType=\"unordered\" styleCode=\"circle\"><item>pain in your right upper stomach-area (abdomen)</item><item>dark urine</item><item>yellowing of your skin or white part of your eyes</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\" colspan=\"4\"><list listType=\"unordered\" styleCode=\"disc\"><item><content styleCode=\"bold\">Infections.</content> TECVAYLI can cause bacterial and viral infections that are severe, life-threatening, or that may cause death. <list listType=\"unordered\" styleCode=\"circle\"><item>Your healthcare provider may prescribe medicines to help prevent infections and treat you as needed if you develop an infection during treatment with TECVAYLI.</item><item>Tell your healthcare provider right away if you get a fever, chills or any signs or symptoms of an infection.</item></list></item><item><content styleCode=\"bold\">Decreased white blood cell counts.</content> Fever sometimes also happens with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.</item><item><content styleCode=\"bold\">Allergic reactions and injection site reactions.</content><list listType=\"unordered\" styleCode=\"circle\"><item><content styleCode=\"bold\">Allergic reactions</content>: can include fever, rash, swollen tongue, or trouble breathing. <content styleCode=\"bold\">Get medical help right away if you develop any symptoms of an allergic reaction during treatment with TECVAYLI.</content></item><item><content styleCode=\"bold\">Injection site reactions:</content> can include redness, heat, swelling, bruising, bacterial skin infection (cellulitis), discomfort, blood collection under the skin at the injection site (hematoma), and rash. Tell your healthcare provider if you develop any severe injection site reactions.</item></list></item></list> Your healthcare provider will check your liver enzymes and white blood cell counts before you start and during treatment with TECVAYLI.   Your healthcare provider will monitor you for signs and symptoms of these serious side effects during treatment and may temporarily or permanently stop TECVAYLI if you develop severe side effects.  <content styleCode=\"bold\">The most common side effects of TECVAYLI when used alone include:</content></td></tr><tr><td styleCode=\"Lrule\" colspan=\"2\"><list listType=\"unordered\" styleCode=\"disc\"><item>fever</item><item>CRS</item><item>muscle, joint, and bone pain</item><item>injection site reaction</item></list></td><td><list listType=\"unordered\" styleCode=\"disc\"><item>tiredness</item><item>upper respiratory tract infection</item><item>nausea</item></list></td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"disc\"><item>headache</item><item>pneumonia</item><item>diarrhea</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">The most common side effects of TECVAYLI when used with daratumumab and hyaluronidase-fihj include:</content></td></tr><tr><td styleCode=\"Lrule\" colspan=\"2\"><list listType=\"unordered\" styleCode=\"disc\"><item>low blood levels of antibodies called immunoglobins</item><item>upper respiratory tract infection</item><item>CRS</item><item>cough</item><item>diarrhea</item></list></td><td><list listType=\"unordered\" styleCode=\"disc\"><item>muscle, joint, and bone pain</item><item>COVID-19</item><item>pneumonia</item><item>injection site reaction</item><item>tiredness</item></list></td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"disc\"><item>fever</item><item>headache</item><item>nausea</item><item>stomach area pain or cramps</item><item>decreased weight</item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">The most common severe abnormal blood test results</content> with TECVAYLI include: decreased white blood cells, red blood cells, and platelets.   These are not all the possible side effects of TECVAYLI.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">General Information about the safe and effective use of TECVAYLI.</content>  Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.   You can ask your pharmacist or healthcare provider for information about TECVAYLI that is written for health professionals.</td></tr><tr><td styleCode=\"Lrule Rrule\" colspan=\"4\"><content styleCode=\"bold\">What are the ingredients in TECVAYLI?</content> <content styleCode=\"bold\">Active ingredient</content>: teclistamab-cqyv  <content styleCode=\"bold\">Inactive ingredients</content>: edetate disodium, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection   Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA   U.S. License Number 1864   For patent information: www.janssenpatents.com   &#xA9; Johnson &amp; Johnson and its affiliates 2022, 2026   For more information about TECVAYLI go to www.TECVAYLI.com or call 1-800-526-7736.</td></tr></tbody></table>"],"mechanism_of_action":["12.1 Mechanism of Action Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro , teclistamab-cqyv activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells."],"recent_major_changes":["Boxed Warnings 8/2025 Indications and Usage ( 1 ) 3/2026 Dosage and Administration ( 2.1 , 2.2 , 2.4 , 2.5 , 2.6 ) 3/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 3/2026"],"storage_and_handling":["Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro , teclistamab-cqyv activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells. 12.2 Pharmacodynamics Serum concentrations of cytokines (IL-6, IL-10, TNF-α, and IFN-γ) and IL-2R were measured before and after administration of step-up dose 1, step-up dose 2, and the three weekly doses of 1.5 mg/kg of TECVAYLI. Increased concentrations of IL-6, IL-10, and IL-2R were observed during this period. 12.3 Pharmacokinetics The C max and C avg of teclistamab-cqyv after the first subcutaneous 1.5 mg/kg TECVAYLI dose increase proportionally over a dosage range of 0.08 mg/kg to 3 mg/kg in monotherapy (0.05 to 2 times the approved recommended treatment dosage). Following the recommended dosage of TECVAYLI monotherapy, 90% of steady state exposure was achieved after 12 weekly TECVAYLI doses (1.5 mg/kg once weekly). The mean accumulation ratio between the first and 13 th weekly dose of TECVAYLI 1.5 mg/kg was 4.2-fold for C max , 4.1-fold for C trough , and 5.3-fold for C avg . The pharmacokinetic characteristics of teclistamab-cqyv were consistent whether used as monotherapy or in combination with daratumumab and hyaluronidase-fihj. The C max , C trough , and C avg of teclistamab-cqyv are presented in Table 16. Table 16: Pharmacokinetic Parameters of Teclistamab-cqyv After Administration of the Recommended Dose in Patients with Relapsed or Refractory Multiple Myeloma C max (µg/mL) C trough (µg/mL) C avg (µg/mL) C avg =average serum teclistamab-cqyv concentration over a dosing interval; C max =maximum serum teclistamab-cqyv concentration; C trough =serum teclistamab-cqyv concentration prior to next dose Note: Data are presented as geometric mean (CV %). TECVAYLI Monotherapy First 1.5 mg/kg dose 6.34 (60%) 5.77 (63%) 4.98 (61%) Steady state of 1.5 mg/kg weekly dosing steady-state exposure for the 13 th weekly dose. 23.8 (55%) 21.1 (63%) 22.8 (57%) TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj First 1.5 mg/kg dose 6.36 (54%) 5.79 (59%) 4.96 (55%) End of 1.5 mg/kg weekly dosing exposure for the 7 th weekly dose. 19.6 (54%) 17.3 (62%) 18.6 (56%) End of 3 mg/kg every two weeks dosing exposure for the 8 th every two weeks dose. 29.9 (55%) 19.8 (85%) 26.2 (62%) Steady state of 3 mg/kg every 4 weeks dosing steady-state exposure for the 5 th Q4W dose. 20.2 (52%) 5.82 (152%) 13.7 (67%) Absorption The mean bioavailability of teclistamab-cqyv was 72% after subcutaneous administration of TECVAYLI. The median (range) T max of teclistamab-cqyv after the first and 13 th TECVAYLI monotherapy treatment doses were 139 (19 to 168) hours and 72 (24 to 168) hours, respectively. Distribution The mean (coefficient of variation [CV]%) volume of distribution of teclistamab-cqyv was 5.63 L (29%). Elimination Teclistamab-cqyv clearance decreases over time, with a mean (CV%) maximal reduction from baseline to the 13 th weekly TECVAYLI monotherapy treatment dose of 40.8% (56%). The geometric mean (CV%) clearance is 0.472 L/day (64%) at the 13 th weekly TECVAYLI monotherapy treatment dose. Patients who discontinue TECVAYLI after the 13 th weekly monotherapy treatment dose are expected to have a 50% reduction from C max in teclistamab-cqyv concentration at a median (5 th to 95 th percentile) time of 15 days (7 to 33 days) after T max and a 97% reduction from C max in teclistamab-cqyv concentration at a median time of 69 days (32 to 163 days) after T max . Specific Populations There were no clinically significant differences in the exposure of teclistamab-cqyv based on age (24 to 84 years), sex, race (White, Black or African American), ethnicity (Hispanic/Latino, not Hispanic/Latino), mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] by Modification of Diet in Renal Disease [MDRD] method: 30 to 89 mL/minute), or mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). The effects of severe renal impairment (eGFR less than 30 mL/minute) or moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN with any AST) on the exposures of teclistamab-cqyv are unknown. Body Weight The volume of distribution and clearance of teclistamab-cqyv increase with increasing body weight (37.6 kg to 164 kg), supporting a weight-based dose. Drug Interaction Studies No clinical studies evaluating the drug interaction potential of teclistamab-cqyv have been conducted. 12.6 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of teclistamab-cqyv or of other teclistamab products. Among patients treated with subcutaneous TECVAYLI at various dosages, anti-teclistamab-cqyv antibodies developed in 1/186 (0.5%) of patients who received monotherapy (up to 27 months) and in 2/379 (0.5%) of patients who received combination therapy with daratumumab and hyaluronidase-fihj (up to 43 months). Because of the low occurrence of anti-teclistamab-cqyv antibodies, the effect of these antibodies on the pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of teclistamab products is unknown."],"indications_and_usage":["1 INDICATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent ( 1 ). as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody ( 1 )."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Can cause hepatotoxicity, including fatalities. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity ( 2.5 , 5.4 ) Infections : Can cause severe, life-threatening, or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity. ( 2.5 , 5.5 ) Neutropenia : Monitor complete blood cell counts at baseline and periodically during treatment. Withhold TECVAYLI based on severity. ( 2.5 , 5.6 ) Hypersensitivity and Other Administration Reactions : Can cause systemic administration-related reactions and local injection site reactions. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity. ( 2.5 , 5.7 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome TECVAYLI can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions [see Adverse Reactions (6.1) ] . In the clinical trials (monotherapy and combination therapy trials; N=448), CRS occurred in 64% of patients who received TECVAYLI at the recommended dosage, with Grade 1 CRS occurring in 46% of patients, Grade 2 in 18%, and Grade 3 in 0.2%. Recurrent CRS occurred in 27% of patients. Most patients experienced CRS during the initial step-up dosing schedule (step-up dose 1 (37%), step-up dose 2 (32%), or the initial treatment dose (20%)). CRS first occurred following subsequent doses of TECVAYLI in 2.5% of patients. The median time to onset of CRS was 2 (range: 1 to 9) days after the most recent dose and the median duration of CRS was 2 (range: 1 to 22) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI step-up dosing schedule to reduce risk of CRS [see Dosage and Administration (2.1 , 2.5) ] . Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI accordingly [see Dosage and Administration (2.3 , 2.5) ] . At the first sign of CRS, immediately evaluate the patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold until CRS resolves or permanently discontinue TECVAYLI based on severity [see Dosage and Administration (2.5) ] . TECVAYLI is available only through a restricted program under a REMS [see Warnings and Precautions (5.3) ]. 5.2 Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome TECVAYLI can cause serious, life-threatening or fatal neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Adverse Reactions (6.1) ] . In the clinical trials (monotherapy and combination therapy trials; N=448), neurologic toxicity occurred in 60% of patients who received TECVAYLI at the recommended dosage, with Grade 3 or 4 neurologic toxicity in 6%. Neurologic toxicities reported in ≥5% of patients included headache (27%), sensory neuropathy (16%), motor dysfunction (15%), insomnia (12%), encephalopathy (11%), and dizziness (8%). Fatal neurologic toxicity occurred in 0.4% of patients, including Guillain-Barré syndrome and status epilepticus (one patient each). In MajesTEC-1, ICANS was reported in 6% of patients who received TECVAYLI as monotherapy at the recommended dosage [see Adverse Reactions (6.1) ] . Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent TECVAYLI doses. The median time to onset of ICANS was 4 days (range: 2 to 8 days) after the most recent TECVAYLI dose with a median duration of 3 days (range: 1 to 20 days). The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. In MajesTEC-3, ICANS was reported in 1.1% of patients who received the recommended TECVAYLI dosage in combination with daratumumab and hyaluronidase-fihj, including Grade 4 ICANS in 1 patient. All events of ICANS occurred during the step-up dosing schedule [see Adverse Reactions (6.1) ] . The median time to onset of ICANS was 2 days (range: 1 to 3 days) after the most recent dose and the median duration of ICANS was 2 days (range: 1 to 2 days). The clinical manifestations of ICANS reported were amnesia, encephalopathy and delirium. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during TECVAYLI treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold until neurologic toxicity resolves or permanently discontinue TECVAYLI based on severity per recommendations and consider further management per current practice guidelines [see Dosage and Administration (2.5) ] . Due to the potential for neurologic toxicity, patients receiving TECVAYLI are at risk of depressed level of consciousness [see Adverse Reactions (6.1) ] . Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves [see Dosage and Administration (2.1) ] . TECVAYLI is available only through a restricted program under a REMS [see Warnings and Precautions (5.3) ]. 5.3 TECVAYLI and TALVEY REMS TECVAYLI is available only through a restricted program under a REMS called the \"TECVAYLI and TALVEY REMS\" because of the risks of CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1 , 5.2) ]. Notable requirements of the TECVAYLI and TALVEY REMS include the following: Prescribers must be certified with the REMS by enrolling and completing training. Prescribers must counsel patients receiving TECVAYLI about the risk of CRS and neurologic toxicity, including ICANS, and provide patients with Patient Wallet Card. Pharmacies and healthcare settings that dispense TECVAYLI must be certified with this REMS and must verify prescribers are certified through this REMS. Wholesalers and distributers must only distribute TECVAYLI to certified pharmacies or healthcare settings. Further information about the \"TECVAYLI and TALVEY REMS\" is available at www.TEC-TALREMS.com or by telephone at 1-855-810-8064. 5.4 Hepatotoxicity TECVAYLI can cause hepatotoxicity, including fatalities. There was one fatal case of hepatic failure in MajesTEC-1. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), elevated aspartate aminotransferase (AST) occurred in 47% of patients, with Grade 3 or 4 elevations in 2.9%. Elevated alanine aminotransferase (ALT) occurred in 48% of patients, with Grade 3 or 4 elevations in 3.8%. Elevated total bilirubin occurred in 10% of patients with Grade 3 or 4 elevations in 0.7%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during TECVAYLI treatment as clinically indicated. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity [see Dosage and Administration (2.5) ]. 5.5 Infections TECVAYLI can cause severe, life-threatening, or fatal infections. In MajesTEC-1 (N=165), in patients who received the recommended TECVAYLI dosage, serious infections, including opportunistic infections, occurred in 30% of patients, Grade 3 or 4 infections occurred in 35% of patients, and fatal infections occurred in 4.2% of patients [see Adverse Reactions (6.1) ] . In MajesTEC-3 (N=283), in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj at the recommended dosage, serious infections, including opportunistic infections, occurred in 54% of patients, Grade 3 or Grade 4 infections occurred in 54% of patients and fatal infections occurred in 4.6% of patients [see Adverse Reactions (6.1) ] . Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI and treat appropriately. Administer prophylactic antimicrobials according to current practice guidelines [see Dosage and Administration (2.3) ] . Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity [see Dosage and Administration (2.5) ] . Monitor immunoglobulin levels prior to and during treatment with TECVAYLI and administer subcutaneous or intravenous immunoglobulin (IVIG) to maintain the serum levels >400 mg/dL. 5.6 Neutropenia TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients [see Adverse Reactions (6.1) ]. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI based on severity [see Dosage and Administration (2.5) ] . 5.7 Hypersensitivity and Other Administration Reactions TECVAYLI can cause both systemic administration-related reactions and local injection-site reactions. Systemic Reactions In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic-administration reactions, which included recurrent pyrexia and rash. Local Reactions In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients with Grade 1 injection-site reactions in 29% and Grade 2 in 9%. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity [see Dosage and Administration (2.5) ] . 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ] ."],"clinical_studies_table":["<table width=\"95%\"><caption>Table 17: Efficacy Results (MajesTEC-3)</caption><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"25%\" align=\"center\" valign=\"top\"/><col width=\"25%\" align=\"center\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule Rrule\"/><th styleCode=\"Rrule\">TECVAYLI with daratumumab and hyaluronidase-fihj   (N=291)</th><th styleCode=\"Rrule\">DPd or DVd   (N=296)</th></tr></thead><tfoot><tr><td align=\"left\" colspan=\"3\">DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone; CI=confidence interval; NE=not estimable; NR=not reached; MRD = minimal residual disease.</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Progression-free survival (PFS)<footnote ID=\"t17fa\">Based on intent-to-treat analysis set</footnote><sup>,</sup><footnote ID=\"t17f1\">Median duration of follow-up = 34.5 months</footnote></content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Number of events, n (%)</td><td styleCode=\"Rrule\">44 (15)</td><td styleCode=\"Rrule\">187 (63)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Median, months (95% CI)</td><td styleCode=\"Rrule\">NR (NE, NE)</td><td styleCode=\"Rrule\">18.1 (14.6, 22.8)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hazard ratio (95% CI)<footnote ID=\"t17fb\">Stratified Cox proportional hazard model. For all stratified analyses, stratification was based on ISS staging (I vs. II or III) and number of prior lines of therapy (1 vs. 2 or 3), as randomized</footnote> ; p-value<footnote ID=\"t17fc\">Stratified log-rank test</footnote></td><td styleCode=\"Rrule\" colspan=\"2\">0.17 (0.12, 0.23); &lt;0.0001</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Overall survival (OS)<footnoteRef IDREF=\"t17fa\"/><sup>,</sup><footnoteRef IDREF=\"t17f1\"/></content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Number of events, n (%)</td><td styleCode=\"Rrule\">46 (16)</td><td styleCode=\"Rrule\">98 (33)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Median, months (95% CI)</td><td styleCode=\"Rrule\">NR (NE, NE)</td><td styleCode=\"Rrule\">NR (41.4, NE)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hazard ratio (95% CI)<footnoteRef IDREF=\"t17fb\"/>; p-value<footnoteRef IDREF=\"t17fc\"/></td><td styleCode=\"Rrule\" colspan=\"2\">0.46 (0.32, 0.65); &lt;0.0001</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Overall response (sCR+CR+VGPR+PR)<footnoteRef IDREF=\"t17fa\"/>, n (%)</content></td><td styleCode=\"Rrule\">259 (89.0)</td><td styleCode=\"Rrule\">223 (75.3)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> 95% CI (%)</td><td styleCode=\"Rrule\">(84.8, 92.4)</td><td styleCode=\"Rrule\">(70.0, 80.1)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> p-value<footnote ID=\"t17fd\">Stratified Cochran Mantel-Haenszel Chi-Squared test</footnote></td><td styleCode=\"Rrule\" colspan=\"2\">&lt;0.0001</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Stringent complete response (sCR), n (%)</td><td styleCode=\"Rrule\">225 (77.3)</td><td styleCode=\"Rrule\">69 (23.3)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Complete response (CR), n (%)</td><td styleCode=\"Rrule\">13 (4.5)</td><td styleCode=\"Rrule\">26 (8.8)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Very good partial response (VGPR), n (%)</td><td styleCode=\"Rrule\">14 (4.8)</td><td styleCode=\"Rrule\">74 (25.0)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Partial response (PR), n (%)</td><td styleCode=\"Rrule\">7 (2.4)</td><td styleCode=\"Rrule\">54 (18.2)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Complete response or better (sCR+CR)<footnoteRef IDREF=\"t17fa\"/>, n (%)</content></td><td styleCode=\"Rrule\">238 (81.8)</td><td styleCode=\"Rrule\">95 (32.1)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> 95% CI (%)</td><td styleCode=\"Rrule\">(76.9, 86.0)</td><td styleCode=\"Rrule\">(26.8, 37.7)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> p-value<footnoteRef IDREF=\"t17fd\"/></td><td styleCode=\"Rrule\" colspan=\"2\">&lt;0.0001</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">MRD negativity rate<footnote>Based on MRD next-generation sequencing (NGS) primary analysis set, defined as all randomized patients enrolled at sites where next generation sequencing assay was available.</footnote><sup>,</sup><footnote ID=\"t17ff\">Based on a threshold of 10<sup>-5</sup> using a next generation sequencing assay (clonoSEQ).</footnote>, N</content></td><td styleCode=\"Rrule\">262</td><td styleCode=\"Rrule\">269</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> n (%)</td><td styleCode=\"Rrule\">153 (58.4)</td><td styleCode=\"Rrule\">46 (17.1)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> 95% CI (%)</td><td styleCode=\"Rrule\">(52.2, 64.4)</td><td styleCode=\"Rrule\">(12.8, 22.1)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> p-value<footnote>Fisher&apos;s exact test</footnote></td><td styleCode=\"Rrule\" colspan=\"2\">&lt;0.0001</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">MRD negativity rate in patients with CR or better <footnoteRef IDREF=\"t17ff\"/></content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Number of patients with CR or better, n </td><td styleCode=\"Rrule\">216</td><td styleCode=\"Rrule\">86</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> MRD negativity rate, n (%)</td><td styleCode=\"Rrule\">153 (70.8)</td><td styleCode=\"Rrule\">46 (53.5)</td></tr><tr><td styleCode=\"Lrule Rrule\"> 95% CI (%)</td><td styleCode=\"Rrule\">(64.3, 76.8)</td><td styleCode=\"Rrule\">(42.4, 64.3)</td></tr></tbody></table>","<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"100%\" align=\"left\" valign=\"top\"/><thead><tr><th>Figure 1: Kaplan-Meier Curve of PFS (MajesTEC-3)</th></tr></thead><tfoot><tr><td align=\"left\">Tec-Dara = TECVAYLI in combination with daratumumab and hyaluronidase-fihj; DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone.</td></tr></tfoot><tbody><tr><td><renderMultiMedia referencedObject=\"MM1\"/></td></tr></tbody></table>","<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"100%\" align=\"left\" valign=\"top\"/><thead><tr><th>Figure 2: Kaplan-Meier Curve of OS (MajesTEC-3)</th></tr></thead><tfoot><tr><td align=\"left\">Tec-Dara = TECVAYLI in combination with daratumumab and hyaluronidase-fihj; DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone.</td></tr></tfoot><tbody><tr><td><renderMultiMedia referencedObject=\"MM2\"/></td></tr></tbody></table>","<table width=\"90%\" ID=\"table18\"><caption>Table 18: Efficacy Results for MajesTEC-1</caption><col width=\"60%\" align=\"left\" valign=\"middle\"/><col width=\"40%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\"/><th styleCode=\"Rrule\">N=110</th></tr></thead><tfoot><tr><td align=\"left\" colspan=\"2\">NE=not estimable</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Overall response rate (ORR: sCR+CR+VGPR+PR) n (%)</content></td><td styleCode=\"Rrule\">68 (61.8)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">95% CI (%)</td><td styleCode=\"Rrule\">(52.1, 70.9)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Complete response (CR) or better<footnote>Complete response or better = Stringent complete response (sCR) + complete response (CR).</footnote></td><td styleCode=\"Rrule\">31 (28.2)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Very good partial response (VGPR)</td><td styleCode=\"Rrule\">32 (29.1)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Partial response (PR) </td><td styleCode=\"Rrule\">5 (4.5)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"2\"><content styleCode=\"bold\">Duration of Response (DOR) (months)</content></td></tr><tr><td styleCode=\"Lrule Rrule\"> DOR (Months): Median (95% CI) </td><td styleCode=\"Rrule\">NE (9.0, NE)</td></tr></tbody></table>"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with teclistamab-cqyv. No studies have been conducted to evaluate the effects of teclistamab-cqyv on fertility."],"pharmacokinetics_table":["<table width=\"95%\"><caption>Table 16: Pharmacokinetic Parameters of Teclistamab-cqyv After Administration of the Recommended Dose in Patients with Relapsed or Refractory Multiple Myeloma</caption><col width=\"40%\" align=\"left\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><col width=\"30%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\"/><th styleCode=\"Rrule\">C<sub>max</sub> (&#xB5;g/mL)</th><th styleCode=\"Rrule\">C<sub>trough</sub> (&#xB5;g/mL)</th><th styleCode=\"Rrule\">C<sub>avg</sub> (&#xB5;g/mL)</th></tr></thead><tfoot><tr><td align=\"left\" colspan=\"4\">C<sub>avg</sub>=average serum teclistamab-cqyv concentration over a dosing interval; C<sub>max</sub>=maximum serum teclistamab-cqyv concentration; C<sub>trough</sub>=serum teclistamab-cqyv concentration prior to next dose</td></tr><tr><td align=\"left\" colspan=\"4\">Note: Data are presented as geometric mean (CV %).</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\" align=\"center\"><content styleCode=\"bold\">TECVAYLI Monotherapy</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">First 1.5 mg/kg dose</td><td styleCode=\"Rrule\">6.34 (60%)</td><td styleCode=\"Rrule\">5.77 (63%)</td><td styleCode=\"Rrule\">4.98 (61%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Steady state of 1.5 mg/kg weekly dosing<footnote>steady-state exposure for the 13<sup>th</sup> weekly dose.</footnote></td><td styleCode=\"Rrule\">23.8 (55%)</td><td styleCode=\"Rrule\">21.1 (63%)</td><td styleCode=\"Rrule\">22.8 (57%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\" align=\"center\"><content styleCode=\"bold\">TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">First 1.5 mg/kg dose</td><td styleCode=\"Rrule\">6.36 (54%)</td><td styleCode=\"Rrule\">5.79 (59%)</td><td styleCode=\"Rrule\">4.96 (55%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">End of 1.5 mg/kg weekly dosing<footnote>exposure for the 7<sup>th</sup> weekly dose.</footnote></td><td styleCode=\"Rrule\">19.6 (54%)</td><td styleCode=\"Rrule\">17.3 (62%)</td><td styleCode=\"Rrule\">18.6 (56%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">End of 3 mg/kg every two weeks dosing<footnote>exposure for the 8<sup>th</sup> every two weeks dose.</footnote></td><td styleCode=\"Rrule\">29.9 (55%)</td><td styleCode=\"Rrule\">19.8 (85%)</td><td styleCode=\"Rrule\">26.2 (62%)</td></tr><tr><td styleCode=\"Lrule Rrule\">Steady state of 3 mg/kg every 4 weeks dosing<footnote>steady-state exposure for the 5<sup>th</sup> Q4W dose. </footnote></td><td styleCode=\"Rrule\">20.2 (52%)</td><td styleCode=\"Rrule\">5.82 (152%)</td><td styleCode=\"Rrule\">13.7 (67%)</td></tr></tbody></table>"],"adverse_reactions_table":["<table width=\"95%\"><caption>Table 12: Adverse Reactions (&#x2265;10%) in Patients with Multiple Myeloma Who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3</caption><col width=\"40%\" align=\"left\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><thead><tr styleCode=\"Botrule\"><th styleCode=\"Lrule Rrule\" rowspan=\"2\">Adverse Reaction</th><th styleCode=\"Rrule\" valign=\"top\" colspan=\"2\">TECVAYLI with daratumumab and hyaluronidase-fihj   (N=283)</th><th styleCode=\"Rrule\" valign=\"top\" colspan=\"2\">DPd or DVd   (N=290)</th></tr><tr><th styleCode=\"Rrule\" align=\"center\">Any Grade   (%)</th><th styleCode=\"Rrule\" align=\"center\">Grade 3 or 4   (%)</th><th styleCode=\"Rrule\" align=\"center\">Any Grade   (%)</th><th styleCode=\"Rrule\" align=\"center\">Grade 3 or 4   (%)</th></tr></thead><tfoot><tr><td colspan=\"5\" align=\"left\">DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone.</td></tr><tr><td colspan=\"5\" align=\"left\">Adverse reactions were graded according to NCI-CTCAE Version 5.0, with the exception of ICANS and CRS, which were graded by ASTCT 2019 consensus grading system; adverse reactions that were considered symptoms of CRS or ICANS were not included.</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Immune system disorders</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hypogammaglobulinemia<footnote>Hypogammaglobulinemia includes hypogammaglobulinemia, hypoglobulinemia; and/or patients with laboratory IgG levels below 400 mg/dL following treatment with TECVAYLI.</footnote></td><td styleCode=\"Rrule\">84</td><td styleCode=\"Rrule\">6 </td><td styleCode=\"Rrule\">60</td><td styleCode=\"Rrule\">1.4</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Cytokine release syndrome</td><td styleCode=\"Rrule\">60</td><td styleCode=\"Rrule\">0</td><td styleCode=\"Rrule\">0</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Infections</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Upper respiratory tract infection<footnote>Upper respiratory tract infection includes bronchitis, bronchiolitis, pharyngitis, rhinitis, sinusitis, sinobronchitis, tracheitis, and tracheobronchitis and other related terms.</footnote></td><td styleCode=\"Rrule\">79</td><td styleCode=\"Rrule\">17</td><td styleCode=\"Rrule\">62</td><td styleCode=\"Rrule\">13</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> COVID-19<footnote ID=\"t12f1\">Includes other related terms.</footnote></td><td styleCode=\"Rrule\">45</td><td styleCode=\"Rrule\">6</td><td styleCode=\"Rrule\">33</td><td styleCode=\"Rrule\">2.1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Pneumonia<footnote>Pneumonia includes atypical pneumonia, bacterial pneumonia, fungal pneumonia, viral pneumonia, and other related terms.</footnote><footnote>Includes the following fatal adverse reactions: Tec-Dara: Pneumonia (n=1); DPd/DVd: Pneumonia (n=2).</footnote></td><td styleCode=\"Rrule\">42</td><td styleCode=\"Rrule\">33</td><td styleCode=\"Rrule\">35</td><td styleCode=\"Rrule\">28</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Gastroenteritis<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">20</td><td styleCode=\"Rrule\">4.9</td><td styleCode=\"Rrule\">8</td><td styleCode=\"Rrule\">0.7</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Urinary tract infection<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">17</td><td styleCode=\"Rrule\">2.8</td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Herpes virus infection<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">2.1</td><td styleCode=\"Rrule\">6</td><td styleCode=\"Rrule\">0.3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Respiratory, thoracic and mediastinal disorders</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Cough<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">53</td><td styleCode=\"Rrule\">0.7</td><td styleCode=\"Rrule\">24</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Dyspnea<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">1.8</td><td styleCode=\"Rrule\">20</td><td styleCode=\"Rrule\">2.1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Gastrointestinal disorders </content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Diarrhea<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">52</td><td styleCode=\"Rrule\">3.9</td><td styleCode=\"Rrule\">31</td><td styleCode=\"Rrule\">2.4</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Nausea</td><td styleCode=\"Rrule\">23</td><td styleCode=\"Rrule\">0</td><td styleCode=\"Rrule\">12</td><td styleCode=\"Rrule\">0.3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Vomiting</td><td styleCode=\"Rrule\">17</td><td styleCode=\"Rrule\">0</td><td styleCode=\"Rrule\">7</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Abdominal pain<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">16</td><td styleCode=\"Rrule\">0.7</td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Constipation</td><td styleCode=\"Rrule\">14</td><td styleCode=\"Rrule\">0</td><td styleCode=\"Rrule\">20</td><td styleCode=\"Rrule\">0.3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Musculoskeletal and connective tissue disorders</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Musculoskeletal pain<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">50</td><td styleCode=\"Rrule\">1.4</td><td styleCode=\"Rrule\">47</td><td styleCode=\"Rrule\">4.5</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">General disorders and administration site conditions</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Injection site reaction<footnoteRef IDREF=\"t12f1\"/><footnote>Includes injection site reactions related to teclistamab, daratumumab and hyaluronidase-fihj, or bortezomib.</footnote></td><td styleCode=\"Rrule\">41</td><td styleCode=\"Rrule\">0</td><td styleCode=\"Rrule\">4.5</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Fatigue<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">39</td><td styleCode=\"Rrule\">3.9</td><td styleCode=\"Rrule\">40</td><td styleCode=\"Rrule\">4.1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Pyrexia</td><td styleCode=\"Rrule\">37</td><td styleCode=\"Rrule\">1.4</td><td styleCode=\"Rrule\">19</td><td styleCode=\"Rrule\">0.3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Edema<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">0.4</td><td styleCode=\"Rrule\">22</td><td styleCode=\"Rrule\">0.3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Nervous system disorders</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Headache<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">26</td><td styleCode=\"Rrule\">1.4</td><td styleCode=\"Rrule\">12</td><td styleCode=\"Rrule\">0.3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Sensory neuropathy<footnote>Sensory neuropathy includes dysaesthesia, hyperaesthesia, hypoaesthesia, paraesthesia, neuralgia, peripheral neuropathy, polyneuropathy, sciatica and other related terms.</footnote></td><td styleCode=\"Rrule\">17</td><td styleCode=\"Rrule\">0.7</td><td styleCode=\"Rrule\">25</td><td styleCode=\"Rrule\">0.3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Motor dysfunction<footnote>Motor dysfunction includes balance disorder, dysarthria, dysphonia, gait disturbance, muscle contracture, muscle spasms, muscle spasticity, muscle twitching, muscular weakness, myopathy, peripheral motor neuropathy, tremor and other related terms.</footnote></td><td styleCode=\"Rrule\">14</td><td styleCode=\"Rrule\">0</td><td styleCode=\"Rrule\">30</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Investigations</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Weight decreased</td><td styleCode=\"Rrule\">20</td><td styleCode=\"Rrule\">2.8</td><td styleCode=\"Rrule\">7</td><td styleCode=\"Rrule\">1.4</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Metabolism and nutrition disorders</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Decreased appetite</td><td styleCode=\"Rrule\">19</td><td styleCode=\"Rrule\">1.1</td><td styleCode=\"Rrule\">7</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Cardiac disorders</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Cardiac arrhythmia<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">1.1</td><td styleCode=\"Rrule\">8</td><td styleCode=\"Rrule\">2.1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Neoplasms</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Second primary malignancy<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">4.6</td><td styleCode=\"Rrule\">9</td><td styleCode=\"Rrule\">4.8</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Vascular disorders</content></td></tr><tr><td styleCode=\"Lrule Rrule\"> Hypertension<footnoteRef IDREF=\"t12f1\"/></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">4.6</td><td styleCode=\"Rrule\">6</td><td styleCode=\"Rrule\">2.4</td></tr></tbody></table>","<table width=\"95%\"><caption>Table 13: Select Laboratory Abnormalities (&#x2265;30%) that Worsened from Baseline in Patients with Multiple Myeloma who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3</caption><col width=\"40%\" align=\"left\" valign=\"bottom\"/><col width=\"15%\" align=\"center\" valign=\"bottom\"/><col width=\"15%\" align=\"center\" valign=\"bottom\"/><col width=\"15%\" align=\"center\" valign=\"bottom\"/><col width=\"15%\" align=\"center\" valign=\"bottom\"/><thead><tr styleCode=\"Botrule\"><th styleCode=\"Lrule Rrule\" rowspan=\"2\">Laboratory Abnormality</th><th styleCode=\"Rrule\" colspan=\"2\">TECVAYLI with daratumumab and hyaluronidase-fihj   (N=283)</th><th styleCode=\"Rrule\" colspan=\"2\">DPd or DVd   (N=290)</th></tr><tr><th styleCode=\"Rrule\" align=\"center\">All Grades   (%)</th><th styleCode=\"Rrule\" align=\"center\">Grade 3 or 4   (%)</th><th styleCode=\"Rrule\" align=\"center\">All Grades   (%)</th><th styleCode=\"Rrule\" align=\"center\">Grade 3 or 4   (%)</th></tr></thead><tfoot><tr><td colspan=\"5\" align=\"left\">DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone.   Percentages calculated with the number of subjects with a baseline and at least one post-treatment value for each lab test as denominator.   Laboratory toxicity grades are derived based on NCI CTCAE Version 5.0.</td></tr><tr><td colspan=\"5\" align=\"left\">The denominator used to calculate the incidence varied from 137 to 282 in Tec-Dara and 135 to 289 in DPd/DVd based on the number of patients with a baseline value and at least one post-treatment value.</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Hematology</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Lymphocyte Count Decreased</td><td styleCode=\"Rrule\">99</td><td styleCode=\"Rrule\">95</td><td styleCode=\"Rrule\">93</td><td styleCode=\"Rrule\">64</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> White Blood Cell Decreased</td><td styleCode=\"Rrule\">94</td><td styleCode=\"Rrule\">60</td><td styleCode=\"Rrule\">96</td><td styleCode=\"Rrule\">74</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Neutrophil Count Decreased</td><td styleCode=\"Rrule\">91</td><td styleCode=\"Rrule\">78</td><td styleCode=\"Rrule\">94</td><td styleCode=\"Rrule\">84</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Platelet Count Decreased</td><td styleCode=\"Rrule\">73</td><td styleCode=\"Rrule\">21</td><td styleCode=\"Rrule\">72</td><td styleCode=\"Rrule\">25</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hemoglobin Decreased</td><td styleCode=\"Rrule\">64</td><td styleCode=\"Rrule\">17</td><td styleCode=\"Rrule\">61</td><td styleCode=\"Rrule\">19</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"5\"><content styleCode=\"bold\">Chemistry</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Alanine Aminotransferase Increased</td><td styleCode=\"Rrule\">60</td><td styleCode=\"Rrule\">5</td><td styleCode=\"Rrule\">33</td><td styleCode=\"Rrule\">2.4</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Aspartate Aminotransferase Increased</td><td styleCode=\"Rrule\">55</td><td styleCode=\"Rrule\">3.9</td><td styleCode=\"Rrule\">22</td><td styleCode=\"Rrule\">1.7</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Potassium Decreased</td><td styleCode=\"Rrule\">52</td><td styleCode=\"Rrule\">15</td><td styleCode=\"Rrule\">35</td><td styleCode=\"Rrule\">8</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> GGT Increased</td><td styleCode=\"Rrule\">51</td><td styleCode=\"Rrule\">5</td><td styleCode=\"Rrule\">24</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Sodium Decreased</td><td styleCode=\"Rrule\">46</td><td styleCode=\"Rrule\">10</td><td styleCode=\"Rrule\">37</td><td styleCode=\"Rrule\">6</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Lipase Increased</td><td styleCode=\"Rrule\">49</td><td styleCode=\"Rrule\">18</td><td styleCode=\"Rrule\">21</td><td styleCode=\"Rrule\">4.7</td></tr><tr><td styleCode=\"Lrule Rrule\"> Serum Amylase Increased</td><td styleCode=\"Rrule\">31</td><td styleCode=\"Rrule\">7</td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">0</td></tr></tbody></table>","<table width=\"95%\"><caption>Table 14: Adverse Reactions (&#x2265;10%) in Patients with Multiple Myeloma Who Received TECVAYLI in MajesTEC-1</caption><col width=\"50%\" align=\"left\" valign=\"bottom\"/><col width=\"25%\" align=\"center\" valign=\"bottom\"/><col width=\"25%\" align=\"center\" valign=\"bottom\"/><thead><tr styleCode=\"Botrule\"><th styleCode=\"Lrule Rrule\" rowspan=\"2\">Adverse Reactions</th><th styleCode=\"Rrule\" colspan=\"2\">TECVAYLI   (N=165)</th></tr><tr><th styleCode=\"Rrule\" align=\"center\">Any Grade   (%)</th><th styleCode=\"Rrule\" align=\"center\">Grade 3 or 4   (%)</th></tr></thead><tfoot><tr><td colspan=\"3\" align=\"left\">Adverse reactions were graded based on NCI-CTCAE Version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria.</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">General disorders and administration site conditions</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Pyrexia</td><td styleCode=\"Rrule\">76</td><td styleCode=\"Rrule\">3<footnote ID=\"t14f1\">Only grade 3 adverse reactions occurred.</footnote></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Injection site reaction<footnote ID=\"t14f2\">Includes other related terms.</footnote></td><td styleCode=\"Rrule\">37</td><td styleCode=\"Rrule\">0.6<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Fatigue<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">33</td><td styleCode=\"Rrule\">2.4<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Chills</td><td styleCode=\"Rrule\">16</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Pain<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">15</td><td styleCode=\"Rrule\">1.8<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Edema<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Immune system disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Cytokine release syndrome</td><td styleCode=\"Rrule\">72</td><td styleCode=\"Rrule\">0.6<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hypogammaglobulinemia<footnote>Hypogammaglobulinemia includes hypogammaglobulinemia and hypoglobulinemia.</footnote></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">1.2<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Musculoskeletal and connective tissue disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Musculoskeletal pain<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">44</td><td styleCode=\"Rrule\">4.2<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Bone pain</td><td styleCode=\"Rrule\">16</td><td styleCode=\"Rrule\">3<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Infections</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Upper respiratory tract infection<footnote>Upper respiratory tract infection includes bronchitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, tracheitis and other related terms.</footnote></td><td styleCode=\"Rrule\">26</td><td styleCode=\"Rrule\">2.4<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Pneumonia<footnote>Pneumonia includes bacterial pneumonia, viral pneumonia, and other related terms.</footnote><footnote ID=\"t14f3\">Includes the following fatal adverse reactions: hemorrhage (n=1), pneumonia (n=3).</footnote></td><td styleCode=\"Rrule\">24</td><td styleCode=\"Rrule\">15</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Urinary tract infection<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">5<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Gastrointestinal disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Nausea</td><td styleCode=\"Rrule\">25</td><td styleCode=\"Rrule\">0.6<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Diarrhea</td><td styleCode=\"Rrule\">21</td><td styleCode=\"Rrule\">2.4<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Constipation</td><td styleCode=\"Rrule\">18</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Vomiting</td><td styleCode=\"Rrule\">12</td><td styleCode=\"Rrule\">0.6<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Nervous system disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Headache</td><td styleCode=\"Rrule\">25</td><td styleCode=\"Rrule\">0.6<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Motor dysfunction<footnote>Motor dysfunction includes cogwheel rigidity, dysgraphia, dysphonia, gait disturbance, hypokinesia, muscle rigidity, muscle spasms, muscular weakness, peroneal nerve palsy, psychomotor hyperactivity, tremor and VI<sup>th</sup> nerve paralysis.</footnote></td><td styleCode=\"Rrule\">16</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Sensory neuropathy<footnote>Sensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis.</footnote></td><td styleCode=\"Rrule\">15</td><td styleCode=\"Rrule\">1.2<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Encephalopathy<footnote>Encephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence.</footnote></td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Vascular disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hypotension</td><td styleCode=\"Rrule\">18</td><td styleCode=\"Rrule\">1.2<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hemorrhage<footnoteRef IDREF=\"t14f2\"/><footnoteRef IDREF=\"t14f3\"/></td><td styleCode=\"Rrule\">12</td><td styleCode=\"Rrule\">1.8</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hypertension<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">12</td><td styleCode=\"Rrule\">4.8<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Respiratory, thoracic, and mediastinal disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hypoxia</td><td styleCode=\"Rrule\">18</td><td styleCode=\"Rrule\">1.8</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Cough<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">15</td><td styleCode=\"Rrule\">0</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Cardiac disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Cardiac arrhythmia<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">16</td><td styleCode=\"Rrule\">1.8</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Metabolism and nutrition disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Decreased appetite</td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">0.6<footnoteRef IDREF=\"t14f1\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Renal and urinary disorders</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr><td styleCode=\"Lrule Rrule\"> Acute kidney injury<footnoteRef IDREF=\"t14f2\"/></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">3.6</td></tr></tbody></table>","<table width=\"95%\"><caption>Table 15: Select Laboratory Abnormalities (&#x2265;30%) That Worsened from Baseline in TECVAYLI Treated Patients with Multiple Myeloma in MajesTEC-1</caption><col width=\"50%\" align=\"left\" valign=\"bottom\"/><col width=\"25%\" align=\"center\" valign=\"bottom\"/><col width=\"25%\" align=\"center\" valign=\"bottom\"/><thead><tr styleCode=\"Botrule\"><th styleCode=\"Lrule Rrule\" rowspan=\"2\">Laboratory Abnormality</th><th styleCode=\"Rrule\" colspan=\"2\">TECVAYLI   (N=165<footnote>The denominator used to calculate the rate varied from 164 to 165 based on the number of patients with a baseline value and at least one post-treatment value.</footnote>)</th></tr><tr><th styleCode=\"Rrule\" align=\"center\">All Grades (%)</th><th styleCode=\"Rrule\" align=\"center\">Grade 3 or 4 (%)</th></tr></thead><tfoot><tr><td colspan=\"3\" align=\"left\">Laboratory toxicity grades are derived based on NCI CTCAE Version 4.03.</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Hematology</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Lymphocyte count decreased</td><td styleCode=\"Rrule\">92</td><td styleCode=\"Rrule\">84</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> White blood cell decreased</td><td styleCode=\"Rrule\">86</td><td styleCode=\"Rrule\">41</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Neutrophil count decreased</td><td styleCode=\"Rrule\">84</td><td styleCode=\"Rrule\">56</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Platelet count decreased</td><td styleCode=\"Rrule\">71</td><td styleCode=\"Rrule\">22</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Hemoglobin decreased</td><td styleCode=\"Rrule\">67</td><td styleCode=\"Rrule\">33</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Chemistry</content></td><td styleCode=\"Rrule\"/><td styleCode=\"Rrule\"/></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Albumin decreased</td><td styleCode=\"Rrule\">68</td><td styleCode=\"Rrule\">6</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Alkaline phosphatase increased</td><td styleCode=\"Rrule\">42</td><td styleCode=\"Rrule\">2.4</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Phosphorus decreased</td><td styleCode=\"Rrule\">38</td><td styleCode=\"Rrule\">13</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Gamma-glutamyl transferase increased</td><td styleCode=\"Rrule\">37</td><td styleCode=\"Rrule\">8</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Sodium decreased</td><td styleCode=\"Rrule\">35</td><td styleCode=\"Rrule\">10</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Aspartate aminotransferase increased</td><td styleCode=\"Rrule\">34</td><td styleCode=\"Rrule\">1.2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"> Calcium (corrected) decreased</td><td styleCode=\"Rrule\">31</td><td styleCode=\"Rrule\">1.2</td></tr><tr><td styleCode=\"Lrule Rrule\"> Creatinine increased</td><td styleCode=\"Rrule\">30</td><td styleCode=\"Rrule\">3</td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cytokine Release Syndrome (CRS) Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Advise patients to remain within proximity of a healthcare facility and that they will be monitored daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ]. Neurologic Toxicity including ICANS Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, confusion, dysgraphia, decreased level of consciousness, aphasia, apraxia, somnolence, disorientation, motor dysfunction, neuropathy, or encephalopathy. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity, including ICANS. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI step-up dosing schedule and in the event of new onset of any neurologic toxicity, including ICANS symptoms until neurologic toxicity resolves [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ]. TECVAYLI and TALVEY REMS TECVAYLI is available only through a restricted program called TECVAYLI and TALVEY REMS. Inform patients that they will be given a Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.3) ]. Hepatotoxicity Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.4) ]. Infections Discuss the signs and symptoms of infection [see Dosage and Administration (2.5) and Warnings and Precautions (5.5) ] . Neutropenia Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Dosage and Administration (2.5) and Warnings and Precautions (5.6) ] . Hypersensitivity and Other Administration Reactions Advise patients to immediately seek medical attention for any signs and symptoms of systemic administration-related reactions. Advise patients that local injection-site reactions may occur and to report any severe reactions [see Warnings and Precautions (5.7) ]. Embryo-Fetal Toxicity Advise pregnant patients and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1 , 8.3) ] . Lactation Advise women not to breastfeed during treatment with TECVAYLI and for 5 months after the last dose [see Use in Specific Populations (8.2) ] ."],"spl_unclassified_section":["Manufactured by: Janssen Biotech, Inc. Horsham, PA 19044, USA U.S. License Number 1864 For patent information: www.janssenpatents.com © Johnson & Johnson and its affiliates 2022, 2026"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION For subcutaneous injection only. ( 2.1 ) Patients should be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Instruct patients to remain within proximity of a healthcare facility and monitored daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule. ( 2.1 ) See Full Prescribing Information for the recommended dosage for TECVAYLI monotherapy and combination therapy. ( 2.2 , 2.3 ) Administer pretreatment medications as recommended. ( 2.3 ) Refer to Tables 8, 9, 10, and 11 to determine the total dose, injection volume, and number of vials based on the patient's body weight. ( 2.6 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) 2.1 Important Dosage and Administration Information TECVAYLI is for subcutaneous injection only. Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Tables 1 and 2 [see Dosage and Administration (2.3) ] . Administer TECVAYLI subcutaneously according to the step-up dosing schedule in Tables 1 and 2 to reduce the incidence and severity of cytokine release syndrome (CRS). Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Instruct patients to remain within proximity of a healthcare facility and monitor them daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1 , 5.2) ] . Refer to Tables 8, 9, 10, and 11 to determine the dosage based on predetermined weight ranges [see Dosage and Administration (2.6) ] . 2.2 Recommended TECVAYLI Dosage In Combination with Daratumumab and Hyaluronidase-fihj The recommended dosing schedule for TECVAYLI in combination with subcutaneous daratumumab and hyaluronidase-fihj is provided in Table 1. TECVAYLI should be administered until disease progression or unacceptable toxicity. Table 1: TECVAYLI Dosage Schedule in Combination with Daratumumab and Hyaluronidase-fihj Dosing schedule Week/Day TECVAYLI Dosage See Table 3 for recommendations on restarting TECVAYLI after dose delays. Concomitant Therapy Day 0 N/A Daratumumab and hyaluronidase-fihj Step-up dosing schedule The Step-up dosing schedule is a component of the recommended TECVAYLI dosage but is not applicable for the daratumumab and hyaluronidase-fihj dosing. Day 1 Step-up dose 1 (0.06 mg/kg) Step-up dose 1 must be administered 20 hours or more after the daratumumab and hyaluronidase-fihj dose. N/A Day 3 Step-up dose 2 (0.3 mg/kg) Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and if adverse reactions occur, step-up dose 2 may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions. N/A Day 7 First treatment dose (1.5 mg/kg) First treatment dose (1.5 mg/kg) may be given between 2 to 4 days after step-up dose 2 and if adverse reactions occur, first full treatment dose may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions. , Administer TECVAYLI at least 3 hours after the daratumumab and hyaluronidase-fihj dose for the first treatment dose. For subsequent doses, administer TECVAYLI at least 15 minutes after the daratumumab and hyaluronidase-fihj dose. Daratumumab and hyaluronidase-fihj Weekly dosing schedule Weeks 2 to 8 1.5 mg/kg once weekly , Maintain a minimum of 5 days between 1.5 mg/kg once weekly doses. Daratumumab and hyaluronidase-fihj once weekly Biweekly (every two weeks) dosing schedule Weeks 9 to 24 3 mg/kg every two weeks , Maintain a minimum of 12 days between 3 mg/kg every two weeks doses. Daratumumab and hyaluronidase-fihj every two weeks Every four weeks dosing schedule Week 25 onwards 3 mg/kg every four weeks , Maintain a minimum of 25 days between 3 mg/kg every four weeks doses. Daratumumab and hyaluronidase-fihj every four weeks For dosage and administration instructions for daratumumab and hyaluronidase-fihj, see Clinical Studies (14.1) and refer to daratumumab and hyaluronidase-fihj monotherapy Prescribing Information. Monotherapy The recommended dosing schedule for TECVAYLI monotherapy is provided in Table 2. TECVAYLI should be administered until disease progression or unacceptable toxicity. Table 2: TECVAYLI Dosage Schedule for Monotherapy Dosing schedule Day Dosage All Patients Step-up dosing schedule See Table 3 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.4) ] . Day 1 Step-up dose 1 0.06 mg/kg Day 4 Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions. Step-up dose 2 0.3 mg/kg Day 7 First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions. First treatment dose 1.5 mg/kg Weekly dosing schedule One week after first treatment dose and once weekly thereafter Maintain a minimum of 5 days between 1.5 mg/kg once weekly doses Subsequent treatment doses 1.5 mg/kg once weekly Patients who have achieved and maintained a complete response or better for a minimum of 6 months Biweekly (every two weeks) dosing schedule The dosing frequency may be decreased to 1.5 mg/kg every two weeks. Maintain a minimum of 12 days between 1.5 mg/kg every two week doses 2.3 Recommended Pretreatment Medications Administer the following pretreatment medications 1 to 3 hours before each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose (see Tables 1 and 2 ), to reduce the risk of CRS [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Corticosteroid (oral or intravenous dexamethasone 16 mg) Histamine-1 (H1) receptor antagonist (oral or intravenous diphenhydramine 50 mg or equivalent) Antipyretics (oral or intravenous acetaminophen 650 mg to 1,000 mg) Administration of pretreatment medications may be required prior to administration of subsequent doses of TECVAYLI in patients who: Repeat doses within the TECVAYLI step-up dosing schedule following a dose delay [see Dosage and Administration (2.4) ]. Experienced CRS following the prior dose of TECVAYLI [see Dosage and Administration (2.5) ]. Prophylaxis for Herpes Zoster Reactivation Prior to starting treatment with TECVAYLI, consider initiation of antiviral prophylaxis to prevent herpes zoster reactivation per guidelines. 2.4 Restarting TECVAYLI after Dosage Delay If a dose of TECVAYLI is delayed, restart therapy based on the recommendations in Table 3 and resume the treatment schedule accordingly [see Dosage and Administration (2.2) ] . Administer pretreatment medications as indicated in Table 3 [see Dosage and Administration (2.3) ]. Table 3: Recommendations for Restarting Therapy with TECVAYLI After Dose Delay Last dose administered Time since the last dose administered Action Step-up dose 1 More than 7 days Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg). Administer pretreatment medications prior to TECVAYLI dose and monitor patients accordingly [see Dosage and Administration (2.3 , 2.5) ] . Step-up dose 2 8 days to 28 days Repeat step-up dose 2 (0.3 mg/kg) and continue TECVAYLI step-up dosing schedule. More than 28 days Consider benefit-risk of restarting TECVAYLI in patients who require a dose delay of more than 28 days due to an adverse reaction. Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg). Weekly treatment dose 28 days or less Continue TECVAYLI 1.5 mg/kg once weekly. 29 days to 56 days Restart TECVAYLI step-up dosing schedule at step-up dose 2 (0.3 mg/kg). More than 56 days Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg). Any biweekly (every two weeks) or every four weeks treatment dose 63 days or less Continue TECVAYLI at last dose given every two weeks or every four weeks schedule. 64 days to 112 days Restart TECVAYLI step-up dosing schedule at step-up dose 2 (0.3 mg/kg). More than 112 days Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg). 2.5 Dosage Modifications for Adverse Reactions Dosage reductions of TECVAYLI are not recommended. Refer to daratumumab and hyaluronidase-fihj Prescribing Information for information about dosage modifications for daratumumab and hyaluronidase-fihj. Dosage delays may be required to manage toxicities related to TECVAYLI [see Warnings and Precautions (5) ]. See Tables 4 , 5 and 6 for recommended actions for adverse reactions of CRS, neurologic toxicity, and ICANS. See Table 7 for recommended actions for other adverse reactions following administration of TECVAYLI. Management of CRS, Neurologic Toxicity, and ICANS Cytokine Release Syndrome Management recommendations for cytokine release syndrome (CRS) are summarized in Table 4. Identify CRS based on clinical presentation [see Warnings and Precautions (5.1) ]. Evaluate and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, withhold TECVAYLI until CRS resolves. Manage according to the recommendations in Table 4 and consider further management per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS. Consider laboratory testing to monitor for disseminated intravascular coagulation (DIC), hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function. Table 4: Recommendations for Management of Cytokine Release Syndrome Grade Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS. Presenting Symptoms Actions Grade 1 Temperature ≥100.4 °F (38 °C) Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as antipyretics or anticytokine therapy. Withhold TECVAYLI until CRS resolves. Grade 2 Temperature ≥100.4 °F (38 °C) with: Hypotension responsive to fluids and not requiring vasopressors, and/or, Oxygen requirement of low-flow nasal cannula Low-flow nasal cannula is ≤6 L/minute, and high-flow nasal cannula is >6 L/minute. or blow-by. Withhold TECVAYLI until CRS resolves. Administer pretreatment medications prior to next dose of TECVAYLI. See Table 3 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.4) ] . Monitor patients for 48 hours following the next TECVAYLI dose. Instruct patients to remain within proximity of a healthcare facility during daily monitoring and consider hospitalization. [see Dosage and Administration (2.1) ]. Grade 3 Temperature ≥100.4 °F (38 °C) with: Hypotension requiring one vasopressor with or without vasopressin, and/or, Oxygen requirement of high-flow nasal cannula , facemask, non-rebreather mask, or Venturi mask. First Occurrence of Grade 3 CRS with Duration <48 Hours: Withhold TECVAYLI until CRS resolves. Provide supportive therapy, which may include intensive care. Administer pretreatment medications prior to next TECVAYLI dose. Patients should be hospitalized for 48 hours following the next TECVAYLI dose . Recurrent Grade 3 CRS or Grade 3 CRS with Duration 48 Hours or Longer: Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care. Grade 4 Temperature ≥100.4 °F (38 °C) with: Hypotension requiring multiple vasopressors (excluding vasopressin), and/or, Oxygen requirement of positive pressure (e.g., continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation). Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care. Neurologic Toxicity and Immune Effector Cell-Associated Neurotoxicity Syndrome Management recommendations for neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS) are summarized in Tables 5 and 6. At the first sign of neurologic toxicity, including ICANS, withhold TECVAYLI and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care, for severe or life-threatening neurologic toxicities, including ICANS [see Warnings and Precautions (5.2) ] . Manage ICANS according to the recommendations in Table 6 and consider further management per current practice guidelines. Table 5: Recommendations for Management of Neurologic Toxicity (excluding ICANS) Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE), version 4.03. Actions Grade 1 Withhold TECVAYLI until neurologic toxicity symptoms resolve or stabilize. See Table 3 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.4) ] . Grade 2 Grade 3 (First occurrence) Withhold TECVAYLI until neurologic toxicity symptoms improve to Grade 1 or less. Provide supportive therapy. Grade 3 (Recurrent) Grade 4 Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care. Table 6: Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome Grade Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS. Presenting Symptoms Management is determined by the most severe reaction, not attributable to any other cause. Actions Grade 1 ICE score 7–9 If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (name 3 objects, e.g., point to clock, pen, button = 3 points); Following Commands (e.g., \"show me 2 fingers\" or \"close your eyes and stick out your tongue\" = 1 point); Writing (ability to write a standard sentence = 1 point; and Attention (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS) = 0 points. , or depressed level of consciousness Not attributable to any other cause. : awakens spontaneously. Withhold TECVAYLI until ICANS resolves. See Table 3 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.4) ]. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis. Grade 2 ICE score 3–6 , or depressed level of consciousness : awakens to voice. Withhold TECVAYLI until ICANS resolves. Administer dexamethasone All references to dexamethasone administration are for dexamethasone or equivalent. 10 mg intravenously every 6 hours and continue dexamethasone use until resolution to Grade 1 or less then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis. Monitor patients for 48 hours following the next TECVAYLI dose. Instruct patients to remain within proximity of a healthcare facility during daily monitoring and consider hospitalization. [see Dosage and Administration (2.1) ] . Grade 3 ICE score 0–2 , or depressed level of consciousness : awakens only to tactile stimulus, or seizures , either: any clinical seizure, focal or generalized, that resolves rapidly, or non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention, or raised intracranial pressure: focal/local edema on neuroimaging . First Occurrence of Grade 3 ICANS: Withhold TECVAYLI until ICANS resolves. Administer dexamethasone 10 mg intravenously every 6 hours and continue dexamethasone use until resolution to Grade 1 or less, then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis. Provide supportive therapy, which may include intensive care. Patients should be hospitalized for 48 hours following the next TECVAYLI dose. Recurrent Grade 3 ICANS: Permanently discontinue TECVAYLI Administer dexamethasone 10 mg intravenously and repeat dose every 6 hours and continue dexamethasone use until resolution to Grade 1 or less, then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis. Provide supportive therapy, which may include intensive care. Grade 4 ICE score 0 , or depressed level of consciousness : either: patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or stupor or coma, or seizures , either: life-threatening prolonged seizure (>5 minutes), or repetitive clinical or electrical seizures without return to baseline in between, or motor findings : deep focal motor weakness such as hemiparesis or paraparesis, or raised intracranial pressure/cerebral edema , with signs/symptoms such as: diffuse cerebral edema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilledema, or Cushing's triad. Permanently discontinue TECVAYLI. Administer dexamethasone 10 mg intravenously and repeat dose every 6 hours and continue dexamethasone use until resolution to Grade 1 or less, then taper. Alternatively, consider administration of methylprednisolone 1,000 mg per day intravenously and continue methylprednisolone 1,000 mg per day intravenously for 2 or more days. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis. Provide supportive therapy, which may include intensive care. Table 7: Recommended TECVAYLI Dosage Modifications for Other Adverse Reactions Adverse Reactions Severity Actions Infections Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. [see Warnings and Precautions (5.5) ] All Grades Withhold TECVAYLI in patients with active infection during the step-up dosing schedule. See Table 3 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.4) ] . Grade 3 Withhold subsequent TECVAYLI doses administered after TECVAYLI step-up dosing schedule until infection improves to Grade 1 or less. Grade 4 Consider permanent discontinuation of TECVAYLI. If TECVAYLI is not permanently discontinued, withhold subsequent TECVAYLI doses administered after TECVAYLI step-up dosing schedule until infection improves to Grade 1 or less. Hematologic Toxicities [see Warnings and Precautions (5.6) and Adverse Reactions (6.1) ] Absolute neutrophil count (ANC) < 0.5 × 10 9 /L Withhold TECVAYLI until ANC is ≥ 0.5 × 10 9 /L. Febrile neutropenia Withhold TECVAYLI until ANC is ≥1 × 10 9 /L and fever resolves. Hemoglobin < 8 g/dL Withhold TECVAYLI until hemoglobin is ≥8 g/dL. Monotherapy: Platelet count < 25,000/mcL or platelet count between 25,000/mcL and 50,000/mcL with bleeding Combination therapy: Platelet count < 50,000/mcL Monotherapy: Withhold TECVAYLI until platelet count is ≥ 25,000/mcL and no evidence of bleeding. Combination therapy: Withhold TECVAYLI until platelet count is ≥ 50,000/mcL and no evidence of bleeding. Other Non-Hematologic Adverse Reactions [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] Grade 3 Withhold TECVAYLI until adverse reaction improves to Grade 1 or less. Grade 4 Consider permanent discontinuation of TECVAYLI. If TECVAYLI is not permanently discontinued, withhold subsequent treatment TECVAYLI doses administered after TECVAYLI step-up dosing schedule until adverse reaction improves to Grade 1 or less. 2.6 Preparation and Administration TECVAYLI is for subcutaneous use by a healthcare provider only. TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and ICANS [see Warnings and Precautions (5.1 , 5.2) ] . TECVAYLI is a clear to slightly opalescent, colorless to light yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is discolored, or cloudy, or if foreign particles are present. TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration. Do not combine TECVAYLI vials of different concentrations to achieve treatment dose. Use aseptic technique to prepare and administer TECVAYLI. Preparation of TECVAYLI Refer to the following reference tables for the preparation of TECVAYLI. Refer to Tables 8, 9, 10 and 11 below to determine the dosage based on predetermined weight ranges. Use Table 8 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 1 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial. Table 8: Step-up Dose 1 (0.06 mg/kg) Injection Volumes and Number of Vials Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial Patient Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial=3 mL) 35 to 39.9 2.2 0.22 1 40 to 44.9 2.5 0.25 1 45 to 49.9 2.8 0.28 1 50 to 59.9 3.3 0.33 1 60 to 69.9 3.9 0.39 1 70 to 79.9 4.5 0.45 1 80 to 89.9 5.1 0.51 1 90 to 99.9 5.7 0.57 1 100 to 109.9 6.3 0.63 1 110 to 119.9 6.9 0.69 1 120 to 129.9 7.5 0.75 1 130 to 139.9 8.1 0.81 1 140 to 149.9 8.7 0.87 1 150 to 160 9.3 0.93 1 Use Table 9 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 2 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial. Table 9: Step-up Dose 2 (0.3 mg/kg) Injection Volumes and Number of Vials Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial Patient Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial=3 mL) 35 to 39.9 11 1.1 1 40 to 44.9 13 1.3 1 45 to 49.9 14 1.4 1 50 to 59.9 16 1.6 1 60 to 69.9 19 1.9 1 70 to 79.9 22 2.2 1 80 to 89.9 25 2.5 1 90 to 99.9 28 2.8 1 100 to 109.9 31 3.1 2 110 to 119.9 34 3.4 2 120 to 129.9 37 3.7 2 130 to 139.9 40 4 2 140 to 149.9 43 4.3 2 150 to 160 47 4.7 2 Use Table 10 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the 1.5 mg/kg dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial. Table 10: 1.5 mg/kg Dose Injection Volumes and Number of Vials Using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial Patient Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial=1.7 mL) 35 to 39.9 56 0.62 1 40 to 44.9 64 0.71 1 45 to 49.9 71 0.79 1 50 to 59.9 83 0.92 1 60 to 69.9 99 1.1 1 70 to 79.9 108 1.2 1 80 to 89.9 126 1.4 1 90 to 99.9 144 1.6 1 100 to 109.9 153 1.7 1 110 to 119.9 171 1.9 2 120 to 129.9 189 2.1 2 130 to 139.9 198 2.2 2 140 to 149.9 216 2.4 2 150 to 160 234 2.6 2 Use Table 11 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the 3 mg/kg dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial. Table 11: 3 mg/kg Dose Injection Volumes and Number of Vials Using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial Patient Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial=1.7 mL) 35 to 39.9 108 1.2 1 40 to 44.9 126 1.4 1 45 to 49.9 144 1.6 1 50 to 59.9 162 1.8 2 60 to 69.9 198 2.2 2 70 to 79.9 225 2.5 2 80 to 89.9 252 2.8 2 90 to 99.9 288 3.2 2 100 to 109.9 315 3.5 3 110 to 119.9 342 3.8 3 120 to 129.9 378 4.2 3 130 to 139.9 405 4.5 3 140 to 149.9 432 4.8 3 150 to 160 468 5.2 4 Remove the appropriate strength TECVAYLI vial(s) from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)]. Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm TECVAYLI in any other way. Gently swirl the vial for approximately 10 seconds to mix. Do not shake. Withdraw the required injection volume of TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle. Each injection volume should not exceed 2 mL. Divide doses that require greater than 2 mL equally into multiple syringes. Use TECVAYLI with stainless steel injection needles and polypropylene or polycarbonate syringe material. Replace the transfer needle with an appropriately sized needle for injection. Administration of TECVAYLI Inject the required volume of TECVAYLI into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, TECVAYLI may be injected into the subcutaneous tissue at other sites (e.g., thigh). If multiple injections are needed, administer injections at least 2 cm apart. Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact. Storage and Disposal If the prepared dosing syringe(s) of TECVAYLI is not used immediately, store syringe(s) at 2 °C to 8 °C (36 °F to 46 °F) or at ambient temperature 15 °C to 30 °C (59 °F to 86 °F) for a maximum of 20 hours. Discard syringe(s) after 20 hours, if not used. Dispose of any unused product or waste material in accordance with local requirements."],"spl_product_data_elements":["TECVAYLI teclistamab-cqyv TECLISTAMAB TECLISTAMAB SODIUM ACETATE ACETIC ACID SUCROSE POLYSORBATE 20 EDETATE DISODIUM WATER Colorless to light yellow TECVAYLI teclistamab-cqyv TECLISTAMAB TECLISTAMAB SODIUM ACETATE ACETIC ACID SUCROSE POLYSORBATE 20 EDETATE DISODIUM WATER Colorless to light yellow"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Injection 30 mg/3 mL (10 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial. 153 mg/1.7 mL (90 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial. Injection 30 mg/3 mL (10 mg/mL) in a single-dose vial ( 3 ) 153 mg/1.7 mL (90 mg/mL) in a single-dose vial ( 3 )"],"recent_major_changes_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"80%\" align=\"left\" valign=\"top\"/><col width=\"20%\" align=\"right\" valign=\"top\"/><tbody><tr><td><linkHtml href=\"#BOX\">Boxed Warnings</linkHtml></td><td>8/2025</td></tr><tr><td>Indications and Usage (<linkHtml href=\"#S1\">1</linkHtml>)</td><td>3/2026</td></tr><tr><td>Dosage and Administration (<linkHtml href=\"#S2.1\">2.1</linkHtml>,<linkHtml href=\"#S2.2\">2.2</linkHtml>,<linkHtml href=\"#S2.4\">2.4</linkHtml>,<linkHtml href=\"#S2.5\">2.5</linkHtml>,<linkHtml href=\"#S2.6\">2.6</linkHtml>)</td><td>3/2026</td></tr><tr><td>Warnings and Precautions (<linkHtml href=\"#S5.1\">5.1</linkHtml>,<linkHtml href=\"#S5.2\">5.2</linkHtml>,<linkHtml href=\"#S5.3\">5.3</linkHtml>,<linkHtml href=\"#S5.4\">5.4</linkHtml>,<linkHtml href=\"#S5.5\">5.5</linkHtml>,<linkHtml href=\"#S5.6\">5.6</linkHtml>,<linkHtml href=\"#S5.7\">5.7</linkHtml>)</td><td>3/2026</td></tr></tbody></table>"],"clinical_pharmacology_table":["<table width=\"95%\"><caption>Table 16: Pharmacokinetic Parameters of Teclistamab-cqyv After Administration of the Recommended Dose in Patients with Relapsed or Refractory Multiple Myeloma</caption><col width=\"40%\" align=\"left\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><col width=\"15%\" align=\"center\" valign=\"middle\"/><col width=\"30%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\"/><th styleCode=\"Rrule\">C<sub>max</sub> (&#xB5;g/mL)</th><th styleCode=\"Rrule\">C<sub>trough</sub> (&#xB5;g/mL)</th><th styleCode=\"Rrule\">C<sub>avg</sub> (&#xB5;g/mL)</th></tr></thead><tfoot><tr><td align=\"left\" colspan=\"4\">C<sub>avg</sub>=average serum teclistamab-cqyv concentration over a dosing interval; C<sub>max</sub>=maximum serum teclistamab-cqyv concentration; C<sub>trough</sub>=serum teclistamab-cqyv concentration prior to next dose</td></tr><tr><td align=\"left\" colspan=\"4\">Note: Data are presented as geometric mean (CV %).</td></tr></tfoot><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\" align=\"center\"><content styleCode=\"bold\">TECVAYLI Monotherapy</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">First 1.5 mg/kg dose</td><td styleCode=\"Rrule\">6.34 (60%)</td><td styleCode=\"Rrule\">5.77 (63%)</td><td styleCode=\"Rrule\">4.98 (61%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Steady state of 1.5 mg/kg weekly dosing<footnote>steady-state exposure for the 13<sup>th</sup> weekly dose.</footnote></td><td styleCode=\"Rrule\">23.8 (55%)</td><td styleCode=\"Rrule\">21.1 (63%)</td><td styleCode=\"Rrule\">22.8 (57%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" colspan=\"4\" align=\"center\"><content styleCode=\"bold\">TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">First 1.5 mg/kg dose</td><td styleCode=\"Rrule\">6.36 (54%)</td><td styleCode=\"Rrule\">5.79 (59%)</td><td styleCode=\"Rrule\">4.96 (55%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">End of 1.5 mg/kg weekly dosing<footnote>exposure for the 7<sup>th</sup> weekly dose.</footnote></td><td styleCode=\"Rrule\">19.6 (54%)</td><td styleCode=\"Rrule\">17.3 (62%)</td><td styleCode=\"Rrule\">18.6 (56%)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">End of 3 mg/kg every two weeks dosing<footnote>exposure for the 8<sup>th</sup> every two weeks dose.</footnote></td><td styleCode=\"Rrule\">29.9 (55%)</td><td styleCode=\"Rrule\">19.8 (85%)</td><td styleCode=\"Rrule\">26.2 (62%)</td></tr><tr><td styleCode=\"Lrule Rrule\">Steady state of 3 mg/kg every 4 weeks dosing<footnote>steady-state exposure for the 5<sup>th</sup> Q4W dose. </footnote></td><td styleCode=\"Rrule\">20.2 (52%)</td><td styleCode=\"Rrule\">5.82 (152%)</td><td styleCode=\"Rrule\">13.7 (67%)</td></tr></tbody></table>"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TECVAYLI in pregnant patients to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. TECVAYLI is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with TECVAYLI should be considered. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of teclistamab-cqyv in human milk, the effect on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to TECVAYLI are unknown. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with TECVAYLI and for 5 months after the last dose. 8.3 Females and Males of Reproductive Potential TECVAYLI may cause fetal harm when administered to a pregnant patient [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating TECVAYLI. Contraception Females Advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of TECVAYLI. 8.4 Pediatric Use The safety and efficacy of TECVAYLI have not been established in pediatric patients. 8.5 Geriatric Use Of the 165 patients with relapsed or refractory multiple myeloma treated with TECVAYLI in MajesTEC-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness. Of the 291 patients with relapsed or refractory multiple myeloma treated with TECVAYLI at the recommended dosage in combination with daratumumab and hyaluronidase-fihj in MajesTEC-3, 51% were younger than 65 years of age, 39% were 65 to 74 years of age, and 11% were 75 years of age or older. No overall differences in effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in effectiveness compared to younger patients. There was a higher incidence of serious adverse reactions in patients 75 years of age or older (83%) and in patients 65 to 74 years of age (77%) as compared to patients younger than 65 years of age (63%)."],"dosage_and_administration_table":["<table width=\"85%\" ID=\"table1\"><caption>Table 1: TECVAYLI Dosage Schedule in Combination with Daratumumab and Hyaluronidase-fihj</caption><col width=\"15%\" align=\"left\" valign=\"middle\"/><col width=\"15%\" align=\"left\" valign=\"middle\"/><col width=\"35%\" align=\"left\" valign=\"middle\"/><col width=\"35%\" align=\"left\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\" align=\"center\"><content styleCode=\"xmChange\">Dosing schedule</content></th><th styleCode=\"Rrule\" align=\"center\">Week/Day</th><th styleCode=\"Rrule\" align=\"center\">TECVAYLI Dosage<footnote><content styleCode=\"xmChange\">See <linkHtml href=\"#table3\">Table 3</linkHtml> for recommendations on restarting TECVAYLI after dose delays.</content></footnote></th><th styleCode=\"Rrule\" align=\"center\" valign=\"bottom\">Concomitant Therapy</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"/><td styleCode=\"Rrule\"><content styleCode=\"xmChange\">Day 0</content></td><td styleCode=\"Rrule\">N/A</td><td styleCode=\"Rrule\">Daratumumab and hyaluronidase-fihj</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\" rowspan=\"3\"><content styleCode=\"xmChange\"><content styleCode=\"bold\">Step-up dosing schedule<footnote><content styleCode=\"xmChange\">The Step-up dosing schedule is a component of the recommended TECVAYLI dosage but is not applicable for the daratumumab and hyaluronidase-fihj dosing.</content></footnote></content></content></td><td styleCode=\"Rrule\">Day 1</td><td styleCode=\"Rrule\">Step-up dose 1 (0.06 mg/kg) <footnote><content styleCode=\"xmChange\">Step-up dose 1 must be administered 20 hours or more after the daratumumab and hyaluronidase-fihj dose.</content></footnote></td><td styleCode=\"Rrule\">N/A</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Day 3</td><td styleCode=\"Rrule\">Step-up dose 2 (0.3 mg/kg) <footnote><content styleCode=\"xmChange\">Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and if adverse reactions occur, step-up dose 2 may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.</content></footnote></td><td styleCode=\"Rrule\">N/A</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Day 7</td><td styleCode=\"Rrule\">First treatment dose (1.5 mg/kg) <footnote><content styleCode=\"xmChange\">First treatment dose (1.5 mg/kg) may be given between 2 to 4 days after step-up dose 2 and if adverse reactions occur, first full treatment dose may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.</content></footnote><sup>,</sup><footnote ID=\"t1ff\"><content styleCode=\"xmChange\">Administer TECVAYLI at least 3 hours after the daratumumab and hyaluronidase-fihj dose for the first treatment dose. For subsequent doses, administer TECVAYLI at least 15 minutes after the daratumumab and hyaluronidase-fihj dose.</content></footnote></td><td styleCode=\"Rrule\">Daratumumab and hyaluronidase-fihj</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\"><content styleCode=\"bold\">Weekly dosing schedule</content></content></td><td styleCode=\"Rrule\">Weeks 2 to 8</td><td styleCode=\"Rrule\">1.5 mg/kg once weekly<footnoteRef IDREF=\"t1ff\"/><sup>,</sup><footnote><content styleCode=\"xmChange\">Maintain a minimum of 5 days between 1.5 mg/kg once weekly doses.</content></footnote></td><td styleCode=\"Rrule\">Daratumumab and hyaluronidase-fihj once weekly</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\"><content styleCode=\"bold\">Biweekly (every two weeks) dosing schedule</content></content></td><td styleCode=\"Rrule\">Weeks 9 to 24</td><td styleCode=\"Rrule\">3 mg/kg every two weeks<footnoteRef IDREF=\"t1ff\"/><sup>,</sup><footnote><content styleCode=\"xmChange\">Maintain a minimum of 12 days between 3 mg/kg every two weeks doses.</content></footnote></td><td styleCode=\"Rrule\">Daratumumab and hyaluronidase-fihj every two weeks</td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\"><content styleCode=\"bold\">Every four weeks dosing schedule</content></content></td><td styleCode=\"Rrule\">Week 25 onwards</td><td styleCode=\"Rrule\">3 mg/kg every four weeks<footnoteRef IDREF=\"t1ff\"/><sup>,</sup><footnote><content styleCode=\"xmChange\">Maintain a minimum of 25 days between 3 mg/kg every four weeks doses.</content></footnote></td><td styleCode=\"Rrule\">Daratumumab and hyaluronidase-fihj every four weeks</td></tr></tbody></table>","<table width=\"90%\" ID=\"table2\"><caption>Table 2: TECVAYLI Dosage Schedule for Monotherapy</caption><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\">Dosing schedule</th><th styleCode=\"Rrule\">Day</th><th colspan=\"2\" styleCode=\"Rrule\">Dosage</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td colspan=\"4\" align=\"left\" styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">All Patients</content></td></tr><tr styleCode=\"Botrule\"><td rowspan=\"3\" styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Step-up dosing schedule<footnote ID=\"t2fa\">See <linkHtml href=\"#table3\">Table 3</linkHtml> for recommendations on restarting TECVAYLI after dose delays <content styleCode=\"italics\">[see <linkHtml href=\"#S2.4\">Dosage and Administration (2.4)</linkHtml>]</content>.</footnote></content></td><td styleCode=\"Rrule\">Day 1</td><td styleCode=\"Rrule\">Step-up dose 1</td><td styleCode=\"Rrule\">0.06 mg/kg</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Day 4<footnote>Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.</footnote></td><td styleCode=\"Rrule\">Step-up dose 2</td><td styleCode=\"Rrule\">0.3 mg/kg</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Day 7<footnote>First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.</footnote></td><td styleCode=\"Rrule\">First treatment dose</td><td styleCode=\"Rrule\">1.5 mg/kg</td></tr><tr styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Weekly dosing schedule<footnoteRef IDREF=\"t2fa\"/></content></td><td styleCode=\"Rrule\">One week after first treatment dose and once weekly thereafter<footnote ID=\"t2fd\"><content styleCode=\"xmChange\">Maintain a minimum of 5 days between 1.5 mg/kg once weekly doses</content></footnote></td><td styleCode=\"Rrule\">Subsequent treatment doses</td><td styleCode=\"Rrule\">1.5 mg/kg once weekly<footnoteRef IDREF=\"t2fd\"/></td></tr><tr styleCode=\"Botrule\"><td colspan=\"4\" align=\"left\" styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Patients who have achieved and maintained a complete response or better for a minimum of 6 months</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Biweekly (every two weeks) dosing schedule<footnoteRef IDREF=\"t2fa\"/></content></td><td colspan=\"3\" styleCode=\"Lrule Rrule\">The dosing frequency may be decreased to 1.5 mg/kg every two weeks.<footnote><content styleCode=\"xmChange\">Maintain a minimum of 12 days between 1.5 mg/kg every two week doses</content></footnote></td></tr></tbody></table>","<table width=\"90%\" ID=\"table3\"><caption>Table 3: Recommendations for Restarting Therapy with TECVAYLI After Dose Delay</caption><col align=\"left\" valign=\"middle\" width=\"27%\"/><col align=\"center\" valign=\"middle\" width=\"27%\"/><col align=\"left\" valign=\"middle\" width=\"46%\"/><thead><tr><th styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">Last dose administered</content></th><th styleCode=\"Rrule\">Time since the last dose administered</th><th align=\"center\" styleCode=\"Rrule\">Action</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">Step-up dose 1</content></td><td styleCode=\"Rrule\">More than 7 days</td><td styleCode=\"Rrule\">Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).<footnote ID=\"t3fa\">Administer pretreatment medications prior to TECVAYLI dose and monitor patients accordingly <content styleCode=\"italics\">[see <linkHtml href=\"#S2.3\">Dosage and Administration (2.3</linkHtml>, <linkHtml href=\"#S2.5\">2.5)</linkHtml>]</content>.</footnote></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" rowspan=\"2\"><content styleCode=\"xmChange\">Step-up dose 2</content></td><td styleCode=\"Rrule\">8 days to 28 days</td><td styleCode=\"Rrule\">Repeat step-up dose 2 (0.3 mg/kg)<footnoteRef IDREF=\"t3fa\"/> and continue TECVAYLI step-up dosing schedule.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\" align=\"center\"><content styleCode=\"xmChange\">More than 28 days<footnote ID=\"t3fb\">Consider benefit-risk of restarting TECVAYLI in patients who require a dose delay of more than 28 days due to an adverse reaction.</footnote></content></td><td styleCode=\"Rrule\" align=\"left\">Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).<footnoteRef IDREF=\"t3fa\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" rowspan=\"3\"><content styleCode=\"xmChange\">Weekly treatment dose</content></td><td styleCode=\"Rrule\">28 days or less</td><td styleCode=\"Rrule\">Continue TECVAYLI 1.5 mg/kg once weekly. </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\" align=\"center\"><content styleCode=\"xmChange\">29 days to 56 days<footnoteRef IDREF=\"t3fb\"/></content></td><td styleCode=\"Rrule\" align=\"left\">Restart TECVAYLI step-up dosing schedule at step-up dose 2 (0.3 mg/kg).<footnoteRef IDREF=\"t3fa\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\" align=\"center\"><content styleCode=\"xmChange\">More than 56 days<footnoteRef IDREF=\"t3fb\"/></content></td><td styleCode=\"Rrule\" align=\"left\">Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).<footnoteRef IDREF=\"t3fa\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" rowspan=\"3\"><content styleCode=\"xmChange\">Any biweekly (every two weeks) or every four weeks treatment dose</content></td><td styleCode=\"Rrule\">63 days or less<footnoteRef IDREF=\"t3fb\"/></td><td styleCode=\"Rrule\">Continue TECVAYLI at last dose given every two weeks or every four weeks schedule.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\" align=\"center\"><content styleCode=\"xmChange\">64 days to 112 days<footnoteRef IDREF=\"t3fb\"/></content></td><td styleCode=\"Rrule\" align=\"left\">Restart TECVAYLI step-up dosing schedule at step-up dose 2 (0.3 mg/kg).<footnoteRef IDREF=\"t3fa\"/></td></tr><tr><td styleCode=\"Rrule\" align=\"center\"><content styleCode=\"xmChange\">More than 112 days<footnoteRef IDREF=\"t3fb\"/></content></td><td styleCode=\"Rrule\" align=\"left\">Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).<footnoteRef IDREF=\"t3fa\"/></td></tr></tbody></table>","<table width=\"90%\" ID=\"table4\"><caption>Table 4: Recommendations for Management of Cytokine Release Syndrome</caption><col width=\"20%\" align=\"left\" valign=\"top\"/><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"left\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule Rrule\">Grade<footnote>Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS.</footnote></th><th align=\"center\" styleCode=\"Rrule\">Presenting Symptoms</th><th align=\"center\" styleCode=\"Rrule\">Actions</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Grade 1</td><td styleCode=\"Rrule\">Temperature &#x2265;100.4 &#xB0;F (38 &#xB0;C)<footnote ID=\"t4fb\">Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as antipyretics or anticytokine therapy.</footnote></td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"disc\"><item>Withhold TECVAYLI until CRS resolves.</item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">Grade 2</content></td><td styleCode=\"Rrule\">Temperature &#x2265;100.4 &#xB0;F (38 &#xB0;C)<footnoteRef IDREF=\"t4fb\"/> with:   Hypotension responsive to fluids and not requiring vasopressors,   and/or,   Oxygen requirement of low-flow nasal cannula<footnote ID=\"t4fd\">Low-flow nasal cannula is &#x2264;6 L/minute, and high-flow nasal cannula is &gt;6 L/minute.</footnote> or blow-by.</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"disc\"><item>Withhold TECVAYLI until CRS resolves.</item><item>Administer pretreatment medications prior to next dose of TECVAYLI.<footnote ID=\"t4fc\">See <linkHtml href=\"#table3\">Table 3</linkHtml> for recommendations on restarting TECVAYLI after dose delays <content styleCode=\"italics\">[see <linkHtml href=\"#S2.4\">Dosage and Administration (2.4)</linkHtml>]</content>.</footnote></item><item>Monitor patients for 48 hours following the next TECVAYLI dose. Instruct patients to remain within proximity of a healthcare facility during daily monitoring and consider hospitalization. <content styleCode=\"italics\">[see <linkHtml href=\"#S2.1\">Dosage and Administration (2.1)</linkHtml>].</content><footnoteRef IDREF=\"t4fc\"/></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" rowspan=\"2\">Grade 3</td><td styleCode=\"Rrule\" rowspan=\"2\">Temperature &#x2265;100.4 &#xB0;F (38 &#xB0;C)<footnoteRef IDREF=\"t4fb\"/> with:   Hypotension requiring one vasopressor with or without vasopressin,   and/or,   Oxygen requirement of high-flow nasal cannula<footnoteRef IDREF=\"t4fd\"/>, facemask, non-rebreather mask, or Venturi mask.</td><td styleCode=\"Rrule\">First Occurrence of Grade 3 CRS with Duration &lt;48 Hours: <list listType=\"unordered\" styleCode=\"disc\"><item>Withhold TECVAYLI until CRS resolves.</item><item>Provide supportive therapy, which may include intensive care.</item><item>Administer pretreatment medications prior to next TECVAYLI dose.<footnoteRef IDREF=\"t4fc\"/></item><item>Patients should be hospitalized for 48 hours following the next TECVAYLI dose<content styleCode=\"italics\">.</content><footnoteRef IDREF=\"t4fc\"/></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\" align=\"left\">Recurrent Grade 3 CRS or Grade 3 CRS with Duration 48 Hours or Longer: <list listType=\"unordered\" styleCode=\"disc\"><item>Permanently discontinue TECVAYLI.</item><item>Provide supportive therapy, which may include intensive care.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\">Grade 4</td><td styleCode=\"Rrule\">Temperature &#x2265;100.4 &#xB0;F (38 &#xB0;C)<footnoteRef IDREF=\"t4fb\"/> with:   Hypotension requiring multiple vasopressors (excluding vasopressin),   and/or,   Oxygen requirement of positive pressure (e.g., continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation).</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"disc\"><item>Permanently discontinue TECVAYLI.</item><item>Provide supportive therapy, which may include intensive care.</item></list></td></tr></tbody></table>","<table width=\"90%\" ID=\"table5\"><caption>Table 5: Recommendations for Management of Neurologic Toxicity (excluding ICANS)</caption><col align=\"left\" valign=\"top\" width=\"30%\"/><col align=\"left\" valign=\"top\" width=\"70%\"/><thead><tr><th align=\"center\" styleCode=\"Lrule Rrule\">Severity<footnote>Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE), version 4.03.</footnote></th><th align=\"center\" styleCode=\"Rrule\">Actions</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Grade 1</td><td styleCode=\"Rrule\">Withhold TECVAYLI until neurologic toxicity symptoms resolve or stabilize.<footnote ID=\"t5fb\">See <linkHtml href=\"#table3\">Table 3</linkHtml> for recommendations on restarting TECVAYLI after dose delays <content styleCode=\"italics\">[see <linkHtml href=\"#S2.4\">Dosage and Administration (2.4)</linkHtml>]</content>.</footnote></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Grade 2   Grade 3 (First occurrence)</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until neurologic toxicity symptoms improve to Grade 1 or less.<footnoteRef IDREF=\"t5fb\"/></item><item>Provide supportive therapy.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\">Grade 3 (Recurrent)   Grade 4</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Permanently discontinue TECVAYLI.</item><item>Provide supportive therapy, which may include intensive care.</item></list></td></tr></tbody></table>","<table width=\"90%\" ID=\"table6\"><caption>Table 6: Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome</caption><col align=\"left\" valign=\"top\" width=\"20%\"/><col align=\"left\" valign=\"top\" width=\"30%\"/><col align=\"left\" valign=\"top\" width=\"50%\"/><thead><tr><th styleCode=\"Lrule Rrule\">Grade<footnote>Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.</footnote></th><th align=\"center\" styleCode=\"Rrule\">Presenting Symptoms<footnote>Management is determined by the most severe reaction, not attributable to any other cause.</footnote></th><th align=\"center\" styleCode=\"Rrule\">Actions</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Grade 1</td><td styleCode=\"Rrule\">ICE score 7&#x2013;9<footnote ID=\"t6fc\">If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: <content styleCode=\"bold\">Orientation</content> (oriented to year, month, city, hospital = 4 points); <content styleCode=\"bold\">Naming</content> (name 3 objects, e.g., point to clock, pen, button = 3 points); <content styleCode=\"bold\">Following Commands</content> (e.g., &quot;show me 2 fingers&quot; or &quot;close your eyes and stick out your tongue&quot; = 1 point); <content styleCode=\"bold\">Writing</content> (ability to write a standard sentence = 1 point; and <content styleCode=\"bold\">Attention</content> (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS) = 0 points.</footnote>,   or depressed level of consciousness<footnote ID=\"t6fd\">Not attributable to any other cause.</footnote>: awakens spontaneously.</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until ICANS resolves.<footnote ID=\"t6fe\">See <linkHtml href=\"#table3\">Table 3</linkHtml> for recommendations on restarting TECVAYLI after dose delays <content styleCode=\"italics\">[see <linkHtml href=\"#S2.4\">Dosage and Administration (2.4)</linkHtml>].</content></footnote></item><item>Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis.</item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Grade 2</td><td styleCode=\"Rrule\">ICE score 3&#x2013;6<footnoteRef IDREF=\"t6fc\"/>,   or depressed level of consciousness<footnoteRef IDREF=\"t6fd\"/>: awakens to voice.</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until ICANS resolves.</item><item>Administer dexamethasone<footnote ID=\"t6ff\">All references to dexamethasone administration are for dexamethasone or equivalent.</footnote> 10 mg intravenously every 6 hours and continue dexamethasone use until resolution to Grade 1 or less then taper.</item><item><content styleCode=\"xmChange\">Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis.</content></item><item><content styleCode=\"xmChange\">Monitor patients for 48 hours following the next TECVAYLI dose. Instruct patients to remain within proximity of a healthcare facility during daily monitoring and consider hospitalization. <content styleCode=\"italics\">[see <linkHtml href=\"#S2.1\">Dosage and Administration (2.1)</linkHtml>]</content>.<footnoteRef IDREF=\"t6fe\"/></content></item></list></td></tr><tr styleCode=\"Botrule\"><td rowspan=\"2\" styleCode=\"Lrule Rrule\">Grade 3</td><td rowspan=\"2\" styleCode=\"Rrule\">ICE score 0&#x2013;2<footnoteRef IDREF=\"t6fc\"/>,   or depressed level of consciousness<footnoteRef IDREF=\"t6fd\"/>: awakens only to tactile stimulus,   or seizures<footnoteRef IDREF=\"t6fd\"/>, either:<list listType=\"unordered\" styleCode=\"Disc\"><item>any clinical seizure, focal or generalized, that resolves rapidly, or</item><item>non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention,</item></list> or raised intracranial pressure: focal/local edema on neuroimaging<footnoteRef IDREF=\"t6fd\"/>.</td><td styleCode=\"Botrule Rrule\">First Occurrence of Grade 3 ICANS:<list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until ICANS resolves.</item><item>Administer dexamethasone<footnoteRef IDREF=\"t6ff\"/> 10 mg intravenously every 6 hours and continue dexamethasone use until resolution to Grade 1 or less, then taper.</item><item>Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis.</item><item><content styleCode=\"xmChange\">Provide supportive therapy, which may include intensive care.</content></item><item><content styleCode=\"xmChange\">Patients should be hospitalized for 48 hours following the next TECVAYLI dose.<footnoteRef IDREF=\"t6fe\"/></content></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Recurrent Grade 3 ICANS:<list listType=\"unordered\" styleCode=\"Disc\"><item>Permanently discontinue TECVAYLI</item><item>Administer dexamethasone<footnoteRef IDREF=\"t6ff\"/> 10 mg intravenously and repeat dose every 6 hours and continue dexamethasone use until resolution to Grade 1 or less, then taper.</item><item>Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis.</item><item>Provide supportive therapy, which may include intensive care.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\">Grade 4</td><td styleCode=\"Rrule\">ICE score 0<footnoteRef IDREF=\"t6fc\"/>,   or depressed level of consciousness<footnoteRef IDREF=\"t6fd\"/>: either:<list listType=\"unordered\" styleCode=\"Disc\"><item>patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or</item><item>stupor or coma,</item></list> or seizures<footnoteRef IDREF=\"t6fd\"/>, either:<list listType=\"unordered\" styleCode=\"Disc\"><item>life-threatening prolonged seizure (&gt;5 minutes), or</item><item>repetitive clinical or electrical seizures without return to baseline in between,</item></list> or motor findings<footnoteRef IDREF=\"t6fd\"/>:<list listType=\"unordered\" styleCode=\"Disc\"><item>deep focal motor weakness such as hemiparesis or paraparesis,</item></list> or raised intracranial pressure/cerebral edema<footnoteRef IDREF=\"t6fd\"/>, with signs/symptoms such as:<list listType=\"unordered\" styleCode=\"Disc\"><item>diffuse cerebral edema on neuroimaging, or</item><item>decerebrate or decorticate posturing, or</item><item>cranial nerve VI palsy, or</item><item>papilledema, or</item><item>Cushing&apos;s triad.</item></list></td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Permanently discontinue TECVAYLI.</item><item>Administer dexamethasone<footnoteRef IDREF=\"t6ff\"/> 10 mg intravenously and repeat dose every 6 hours and continue dexamethasone use until resolution to Grade 1 or less, then taper.</item><item>Alternatively, consider administration of methylprednisolone 1,000 mg per day intravenously and continue methylprednisolone 1,000 mg per day intravenously for 2 or more days.</item><item>Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure drugs for seizure prophylaxis.</item><item>Provide supportive therapy, which may include intensive care.</item></list></td></tr></tbody></table>","<table width=\"90%\" ID=\"table7\"><caption>Table 7: Recommended TECVAYLI Dosage Modifications for Other Adverse Reactions</caption><col align=\"left\" valign=\"top\" width=\"33%\"/><col align=\"left\" valign=\"top\" width=\"27%\"/><col align=\"left\" valign=\"top\" width=\"40%\"/><thead><tr><th styleCode=\"Lrule Rrule\">Adverse Reactions</th><th styleCode=\"Rrule\" align=\"center\">Severity</th><th styleCode=\"Rrule\" align=\"center\">Actions</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" rowspan=\"3\">Infections<footnote ID=\"t7fa\">Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.</footnote><content styleCode=\"italics\">[see <linkHtml href=\"#S5.5\">Warnings and Precautions (5.5)</linkHtml>]</content></td><td styleCode=\"Rrule\">All Grades</td><td styleCode=\"Rrule\">Withhold TECVAYLI in patients with active infection during the step-up dosing schedule.<footnote ID=\"t7fb\">See <linkHtml href=\"#table3\">Table 3</linkHtml> for recommendations on restarting TECVAYLI after dose delays <content styleCode=\"italics\">[see <linkHtml href=\"#S2.4\">Dosage and Administration (2.4)</linkHtml>]</content>.</footnote></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Grade 3</td><td styleCode=\"Rrule\">Withhold subsequent TECVAYLI doses administered after TECVAYLI step-up dosing schedule until infection improves to Grade 1 or less.<footnoteRef IDREF=\"t7fb\"/></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Grade 4</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Consider permanent discontinuation of TECVAYLI.</item><item>If TECVAYLI is not permanently discontinued, withhold subsequent TECVAYLI doses administered after TECVAYLI step-up dosing schedule until infection improves to Grade 1 or less.<footnoteRef IDREF=\"t7fb\"/></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" rowspan=\"4\"><content styleCode=\"xmChange\">Hematologic Toxicities <content styleCode=\"italics\">[see <linkHtml href=\"#S5.6\">Warnings and Precautions (5.6)</linkHtml> and <linkHtml href=\"#S6.1\">Adverse Reactions (6.1)</linkHtml>]</content></content></td><td styleCode=\"Rrule\">Absolute neutrophil count (ANC) &lt; 0.5 &#xD7; 10<sup>9</sup>/L</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until ANC is &#x2265; 0.5 &#xD7; 10<sup>9</sup>/L.<footnoteRef IDREF=\"t7fb\"/></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Febrile neutropenia</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until ANC is &#x2265;1 &#xD7; 10<sup>9</sup>/L and fever resolves.<footnoteRef IDREF=\"t7fb\"/></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">Hemoglobin &lt; 8 g/dL</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until hemoglobin is &#x2265;8 g/dL.<footnoteRef IDREF=\"t7fb\"/></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\"><content styleCode=\"xmChange\">Monotherapy: Platelet count &lt; 25,000/mcL or platelet count between 25,000/mcL and 50,000/mcL with bleeding   Combination therapy: Platelet count &lt; 50,000/mcL</content></td><td styleCode=\"Rrule\">Monotherapy: <list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until platelet count is &#x2265; 25,000/mcL and no evidence of bleeding.<footnoteRef IDREF=\"t7fb\"/></item></list> Combination therapy:<list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold TECVAYLI until platelet count is &#x2265; 50,000/mcL and no evidence of bleeding. <footnoteRef IDREF=\"t7fb\"/></item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" rowspan=\"2\">Other Non-Hematologic Adverse Reactions<footnoteRef IDREF=\"t7fa\"/><content styleCode=\"italics\">[see <linkHtml href=\"#S5.4\">Warnings and Precautions (5.4)</linkHtml> and <linkHtml href=\"#S6.1\">Adverse Reactions (6.1)</linkHtml>]</content></td><td styleCode=\"Rrule\">Grade 3</td><td styleCode=\"Rrule\">Withhold TECVAYLI until adverse reaction improves to Grade 1 or less.<footnoteRef IDREF=\"t7fb\"/></td></tr><tr><td styleCode=\"Rrule\">Grade 4</td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Consider permanent discontinuation of TECVAYLI.</item><item>If TECVAYLI is not permanently discontinued, withhold subsequent treatment TECVAYLI doses administered after TECVAYLI step-up dosing schedule until adverse reaction improves to Grade 1 or less.<footnoteRef IDREF=\"t7fb\"/></item></list></td></tr></tbody></table>","<table width=\"85%\"><caption>Table 8: Step-up Dose 1 (0.06 mg/kg) Injection Volumes and Number of Vials Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial</caption><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">Patient Body Weight   (kg)</content></th><th styleCode=\"Rrule\">Total Dose   (mg)</th><th styleCode=\"Rrule\">Volume of Injection   (mL)</th><th styleCode=\"Rrule\">Number of Vials   (1 vial=3 mL)</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">35 to 39.9</content></td><td styleCode=\"Rrule\">2.2</td><td styleCode=\"Rrule\">0.22</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">40 to 44.9</content></td><td styleCode=\"Rrule\">2.5</td><td styleCode=\"Rrule\">0.25</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">45 to 49.9</content></td><td styleCode=\"Rrule\">2.8</td><td styleCode=\"Rrule\">0.28</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">50 to 59.9</content></td><td styleCode=\"Rrule\">3.3</td><td styleCode=\"Rrule\">0.33</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">60 to 69.9</content></td><td styleCode=\"Rrule\">3.9</td><td styleCode=\"Rrule\">0.39</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">70 to 79.9</content></td><td styleCode=\"Rrule\">4.5</td><td styleCode=\"Rrule\">0.45</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">80 to 89.9</content></td><td styleCode=\"Rrule\">5.1</td><td styleCode=\"Rrule\">0.51</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">90 to 99.9</content></td><td styleCode=\"Rrule\">5.7</td><td styleCode=\"Rrule\">0.57</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">100 to 109.9</content></td><td styleCode=\"Rrule\">6.3</td><td styleCode=\"Rrule\">0.63</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">110 to 119.9</content></td><td styleCode=\"Rrule\">6.9</td><td styleCode=\"Rrule\">0.69</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">120 to 129.9</content></td><td styleCode=\"Rrule\">7.5</td><td styleCode=\"Rrule\">0.75</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">130 to 139.9</content></td><td styleCode=\"Rrule\">8.1</td><td styleCode=\"Rrule\">0.81</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">140 to 149.9</content></td><td styleCode=\"Rrule\">8.7</td><td styleCode=\"Rrule\">0.87</td><td styleCode=\"Rrule\">1</td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">150 to 160</content></td><td styleCode=\"Rrule\">9.3</td><td styleCode=\"Rrule\">0.93</td><td styleCode=\"Rrule\">1</td></tr></tbody></table>","<table width=\"85%\"><caption>Table 9: Step-up Dose 2 (0.3 mg/kg) Injection Volumes and Number of Vials Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial</caption><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">Patient Body Weight   (kg)</content></th><th styleCode=\"Rrule\">Total Dose   (mg)</th><th styleCode=\"Rrule\">Volume of Injection   (mL)</th><th styleCode=\"Rrule\">Number of Vials   (1 vial=3 mL)</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">35 to 39.9</content></td><td styleCode=\"Rrule\">11</td><td styleCode=\"Rrule\">1.1</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">40 to 44.9</content></td><td styleCode=\"Rrule\">13</td><td styleCode=\"Rrule\">1.3</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">45 to 49.9</content></td><td styleCode=\"Rrule\">14</td><td styleCode=\"Rrule\">1.4</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">50 to 59.9</content></td><td styleCode=\"Rrule\">16</td><td styleCode=\"Rrule\">1.6</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">60 to 69.9</content></td><td styleCode=\"Rrule\">19</td><td styleCode=\"Rrule\">1.9</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">70 to 79.9</content></td><td styleCode=\"Rrule\">22</td><td styleCode=\"Rrule\">2.2</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">80 to 89.9</content></td><td styleCode=\"Rrule\">25</td><td styleCode=\"Rrule\">2.5</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">90 to 99.9</content></td><td styleCode=\"Rrule\">28</td><td styleCode=\"Rrule\">2.8</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">100 to 109.9</content></td><td styleCode=\"Rrule\">31</td><td styleCode=\"Rrule\">3.1</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">110 to 119.9</content></td><td styleCode=\"Rrule\">34</td><td styleCode=\"Rrule\">3.4</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">120 to 129.9</content></td><td styleCode=\"Rrule\">37</td><td styleCode=\"Rrule\">3.7</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">130 to 139.9</content></td><td styleCode=\"Rrule\">40</td><td styleCode=\"Rrule\">4</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">140 to 149.9</content></td><td styleCode=\"Rrule\">43</td><td styleCode=\"Rrule\">4.3</td><td styleCode=\"Rrule\">2</td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">150 to 160</content></td><td styleCode=\"Rrule\">47</td><td styleCode=\"Rrule\">4.7</td><td styleCode=\"Rrule\">2</td></tr></tbody></table>","<table width=\"85%\"><caption>Table 10: 1.5 mg/kg Dose Injection Volumes and Number of Vials Using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial</caption><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">Patient Body Weight   (kg)</content></th><th styleCode=\"Rrule\">Total Dose   (mg)</th><th styleCode=\"Rrule\">Volume of Injection   (mL)</th><th styleCode=\"Rrule\">Number of Vials   (1 vial=1.7 mL)</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">35 to 39.9</content></td><td styleCode=\"Rrule\">56</td><td styleCode=\"Rrule\">0.62</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">40 to 44.9</content></td><td styleCode=\"Rrule\">64</td><td styleCode=\"Rrule\">0.71</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">45 to 49.9</content></td><td styleCode=\"Rrule\">71</td><td styleCode=\"Rrule\">0.79</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">50 to 59.9</content></td><td styleCode=\"Rrule\">83</td><td styleCode=\"Rrule\">0.92</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">60 to 69.9</content></td><td styleCode=\"Rrule\">99</td><td styleCode=\"Rrule\">1.1</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">70 to 79.9</content></td><td styleCode=\"Rrule\">108</td><td styleCode=\"Rrule\">1.2</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">80 to 89.9</content></td><td styleCode=\"Rrule\">126</td><td styleCode=\"Rrule\">1.4</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">90 to 99.9</content></td><td styleCode=\"Rrule\">144</td><td styleCode=\"Rrule\">1.6</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">100 to 109.9</content></td><td styleCode=\"Rrule\">153</td><td styleCode=\"Rrule\">1.7</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">110 to 119.9</content></td><td styleCode=\"Rrule\">171</td><td styleCode=\"Rrule\">1.9</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">120 to 129.9</content></td><td styleCode=\"Rrule\">189</td><td styleCode=\"Rrule\">2.1</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">130 to 139.9</content></td><td styleCode=\"Rrule\">198</td><td styleCode=\"Rrule\">2.2</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">140 to 149.9</content></td><td styleCode=\"Rrule\">216</td><td styleCode=\"Rrule\">2.4</td><td styleCode=\"Rrule\">2</td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">150 to 160</content></td><td styleCode=\"Rrule\">234</td><td styleCode=\"Rrule\">2.6</td><td styleCode=\"Rrule\">2</td></tr></tbody></table>","<table width=\"85%\"><caption>Table 11: 3 mg/kg Dose Injection Volumes and Number of Vials Using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial</caption><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><col width=\"25%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">Patient Body Weight   (kg)</content></th><th styleCode=\"Rrule\">Total Dose   (mg)</th><th styleCode=\"Rrule\">Volume of Injection   (mL)</th><th styleCode=\"Rrule\">Number of Vials   (1 vial=1.7 mL)</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">35 to 39.9</content></td><td styleCode=\"Rrule\">108</td><td styleCode=\"Rrule\">1.2</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">40 to 44.9</content></td><td styleCode=\"Rrule\">126</td><td styleCode=\"Rrule\">1.4</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">45 to 49.9</content></td><td styleCode=\"Rrule\">144</td><td styleCode=\"Rrule\">1.6</td><td styleCode=\"Rrule\">1</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">50 to 59.9</content></td><td styleCode=\"Rrule\">162</td><td styleCode=\"Rrule\">1.8</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">60 to 69.9</content></td><td styleCode=\"Rrule\">198</td><td styleCode=\"Rrule\">2.2</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">70 to 79.9</content></td><td styleCode=\"Rrule\">225</td><td styleCode=\"Rrule\">2.5</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">80 to 89.9</content></td><td styleCode=\"Rrule\">252</td><td styleCode=\"Rrule\">2.8</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">90 to 99.9</content></td><td styleCode=\"Rrule\">288</td><td styleCode=\"Rrule\">3.2</td><td styleCode=\"Rrule\">2</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">100 to 109.9</content></td><td styleCode=\"Rrule\">315</td><td styleCode=\"Rrule\">3.5</td><td styleCode=\"Rrule\">3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">110 to 119.9</content></td><td styleCode=\"Rrule\">342</td><td styleCode=\"Rrule\">3.8</td><td styleCode=\"Rrule\">3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">120 to 129.9</content></td><td styleCode=\"Rrule\">378</td><td styleCode=\"Rrule\">4.2</td><td styleCode=\"Rrule\">3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">130 to 139.9</content></td><td styleCode=\"Rrule\">405</td><td styleCode=\"Rrule\">4.5</td><td styleCode=\"Rrule\">3</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">140 to 149.9</content></td><td styleCode=\"Rrule\">432</td><td styleCode=\"Rrule\">4.8</td><td styleCode=\"Rrule\">3</td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"xmChange\">150 to 160</content></td><td styleCode=\"Rrule\">468</td><td styleCode=\"Rrule\">5.2</td><td styleCode=\"Rrule\">4</td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 mg/3 mL Vial Carton Rx only One Vial NDC 57894-449-01 TECVAYLI ® (teclistamab-cqyv) Injection 30 mg/3 mL (10 mg/mL) TECVAYLI ® vials of different concentrations should not be combined to achieve treatment dose. For subcutaneous injection by a healthcare provider only. Attention: Dispense the enclosed Medication Guide to each patient. Single-dose vial Discard unused portion. janssen PRINCIPAL DISPLAY PANEL - 30 mg/3 mL Vial Carton","PRINCIPAL DISPLAY PANEL - 153 mg/1.7 mL Vial Carton Rx only One Vial NDC 57894-450-01 TECVAYLI ® (teclistamab-cqyv) Injection 153 mg/1.7 mL (90 mg/mL) TECVAYLI ® vials of different concentrations should not be combined to achieve treatment dose. For subcutaneous injection by a healthcare provider only. Attention: Dispense the enclosed Medication Guide to each patient. Single-dose vial Discard unused portion. janssen PRINCIPAL DISPLAY PANEL - 153 mg/1.7 mL Vial Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with teclistamab-cqyv. No studies have been conducted to evaluate the effects of teclistamab-cqyv on fertility."]},"tags":[{"label":"Monoclonal Antibody","category":"modality"},{"label":"Tumor necrosis factor receptor superfamily member 17","category":"target"},{"label":"TNFRSF17","category":"gene"},{"label":"CD3D","category":"gene"},{"label":"CD3E","category":"gene"},{"label":"Subcutaneous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Relapsed or refractory multiple myeloma","category":"indication"},{"label":"Janssen Biotech","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )"],"safetySignals":[{"date":"","signal":"CYTOKINE RELEASE SYNDROME","source":"FDA FAERS","actionTaken":"450 reports"},{"date":"","signal":"IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME","source":"FDA FAERS","actionTaken":"172 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"140 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"129 reports"},{"date":"","signal":"PLASMA CELL MYELOMA","source":"FDA FAERS","actionTaken":"114 reports"},{"date":"","signal":"INFECTION","source":"FDA FAERS","actionTaken":"94 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"83 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"82 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"73 reports"},{"date":"","signal":"COVID-19","source":"FDA FAERS","actionTaken":"69 reports"}],"drugInteractions":[{"drug":"CYP substrates","severity":"major","mechanism":"TECVAYLI causes release of cytokines that may suppress activity of certain cytochrome P450 (CYP) enzymes, leading to increased exposure of CYP substrates","management":"Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate as needed.","clinicalEffect":"Increased risk of adverse reactions of the CYP substrates due to increased exposure"}],"commonSideEffects":[{"effect":"pyrexia","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"cytokine release syndrome","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"musculoskeletal pain","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"injection site reaction","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"fatigue","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"upper respiratory tract infection","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"nausea","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"headache","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"pneumonia","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"diarrhea","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"hypogammaglobulinemia","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"cough","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"COVID-19","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"gastroenteritis","drugRate":"≥20%","_validated":true,"placeboRate":""},{"effect":"weight decreased","drugRate":"≥20%","_validated":true,"placeboRate":""}],"specialPopulations":{"Pregnancy":"Based on the mechanism of action, TECVAYLI may cause fetal harm when administered to pregnant woman. There are no available data on the use of TECVAYLI in pregnant women. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin (IgG) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. TECVAYLI is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with TECVAYLI should be considered.","Geriatric use":"Of the 165 patients with relapsed or refractory multiple myeloma treated with TECVAYLI in MajesTEC-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. There is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.","Paediatric use":"The safety and efficacy of TECVAYLI have not been established in pediatric patients."},"discontinuationRates":[{"trial":"MajesTEC-3","drugArm":"6%","placeboArm":"","commonReason":"Adverse reactions leading to discontinuation of TECVAYLI in more than one patient were pneumonia (1.1%), diarrhea (0.7%), fatigue (0.7%), second primary malignancy (0.7%), upper respiratory tract infection (0.7%) and cough (0.7%)"}],"seriousAdverseEvents":[{"event":"pneumonia","detail":"Serious adverse reaction","severity":"serious","incidence":"33%"},{"event":"upper respiratory tract infection","detail":"Serious adverse reaction","severity":"serious","incidence":"15%"},{"event":"cytokine release syndrome","detail":"Serious adverse reaction","severity":"serious","incidence":"10%"},{"event":"COVID-19","detail":"Serious adverse reaction","severity":"serious","incidence":"7%"},{"event":"sepsis","detail":"Serious adverse reaction","severity":"serious","incidence":"6%"},{"event":"second primary malignancy","detail":"Serious adverse reaction","severity":"serious","incidence":"5%"},{"event":"pyrexia","detail":"Serious adverse reaction","severity":"serious","incidence":"4.9%"},{"event":"febrile neutropenia","detail":"Serious adverse reaction","severity":"serious","incidence":"4.6%"},{"event":"gastroenteritis","detail":"Serious adverse reaction","severity":"serious","incidence":"4.2%"}]},"trials":[],"aliases":[],"company":"Johnson & Johnson","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TECLISTAMAB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:27:43.876258+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:29:37.059742+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:27:49.507511+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:27:43.948532+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:27:39.866668+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TECLISTAMAB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:27:49.863705+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:38.688904+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:29:29.953591+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologi","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:38.688940+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:27:51.397118+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"12.1 Mechanism of Action Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro , teclistamab-cqyv activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:28:08.750780+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tumor necrosis factor receptor superfamily member 17 binding agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:27:50.913663+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:29:09.060847+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4594505/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:27:50.573818+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS The following adverse reactions are also described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity including ICANS [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Infections [see Warnings and Precautions (5.5) ] Neutropenia [see Warnings and Precautions (5.6) ] Hypersensitivity and Other Administration Reactions [see Warnings and Precautions (5.7) ] The most common advers","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:28:59.204643+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA761291","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:27:38.688946+00:00"}},"allNames":"bcmaxcd3","offLabel":[],"synonyms":["teclistamab","teclistamab-cqyv","tecvayli","JNJ-64007957","BCMAxCD3"],"timeline":[{"date":"2022-08-23","type":"positive","source":"DrugCentral","milestone":"EMA approval (Janssen-Cilag International N.V.)"},{"date":"2022-10-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Janssen Biotech)"}],"aiSummary":"Teclistamab-cqyv, marketed by Johnson & Johnson, is a bispecific antibody targeting CD3 and BCMA for the treatment of relapsed or refractory multiple myeloma, positioning it in a competitive landscape with several other drugs targeting similar mechanisms. Its key strength lies in its ability to activate T-cells and induce lysis of multiple myeloma cells, offering a potent combination therapy option. The primary risk is the expiration of its key composition patent in 2028, which could lead to increased competition from generics and biosimilars.","approvals":[{"date":"2022-08-23","orphan":false,"company":"JANSSEN-CILAG INTERNATIONAL N.V.","regulator":"EMA"},{"date":"2022-10-25","orphan":true,"company":"JANSSEN BIOTECH","regulator":"FDA"}],"brandName":"Bcmaxcd3","ecosystem":[{"indication":"Relapsed or refractory multiple myeloma","otherDrugs":[{"name":"elranatamab","slug":"elranatamab","company":"Pfizer Inc"},{"name":"melphalan flufenamide","slug":"melphalan-flufenamide","company":"Oncopeptides Ab"},{"name":"talquetamab","slug":"talquetamab","company":"Janssen Biotech "}],"globalPrevalence":176000}],"mechanism":{"target":"CD3, BCMA","novelty":"Follow-on","targets":[{"gene":"TNFRSF17","source":"DrugCentral","target":"Tumor necrosis factor receptor superfamily member 17","protein":"Tumor necrosis factor receptor superfamily member 17"},{"gene":"CD3D","source":"DrugCentral","target":"T-cell surface glycoprotein CD3","protein":"T-cell surface glycoprotein CD3 delta chain"},{"gene":"CD3E","source":"DrugCentral","target":"T-cell surface glycoprotein CD3","protein":"T-cell surface glycoprotein CD3 epsilon chain"},{"gene":"CD3G","source":"DrugCentral","target":"T-cell surface glycoprotein CD3","protein":"T-cell surface glycoprotein CD3 gamma chain"}],"modality":"Monoclonal antibody","explanation":"Teclistamab-cqyv is a bispecific antibody that targets both the CD3 receptor on T-cells and BCMA on multiple myeloma cells. When it binds to these receptors, it activates T-cells, causing them to release proinflammatory cytokines and destroy the cancer cells.","oneSentence":"Teclistamab-cqyv activates T-cells by binding to CD3 and BCMA, leading to the lysis of multiple myeloma cells.","technicalDetail":"Teclistamab-cqyv binds to the CD3 receptor on T-cells and BCMA on multiple myeloma cells. This binding activates T-cells, resulting in the release of various proinflammatory cytokines and the lysis of multiple myeloma cells."},"commercial":{"launchDate":"2022","revenueYear":2024,"_launchSource":"DrugCentral (FDA 2022-10-25, JANSSEN BIOTECH)","annualRevenue":400,"revenueSource":"Verified: J&J 10-K","revenueCurrency":"USD","revenueConfidence":"verified"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5706","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TECLISTAMAB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TECLISTAMAB","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T15:48:58.999896","_validation":{"fieldsValidated":4,"lastValidatedAt":"2026-04-20T00:29:37.060193+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"blinatumomab","drugSlug":"blinatumomab","fdaApproval":"2014-12-03","relationship":"same-target"},{"drugName":"epcoritamab","drugSlug":"epcoritamab","fdaApproval":"2023-05-19","relationship":"same-target"},{"drugName":"muromonab-CD3","drugSlug":"muromonab-cd3","fdaApproval":"1992-09-14","relationship":"same-target"},{"drugName":"talquetamab","drugSlug":"talquetamab","fdaApproval":"2023-08-09","relationship":"same-target"},{"drugName":"tebentafusp","drugSlug":"tebentafusp","fdaApproval":"2022-01-25","relationship":"same-target"},{"drugName":"teplizumab","drugSlug":"teplizumab","fdaApproval":"2022-11-17","relationship":"same-target"}],"genericName":"teclistamab","indications":{"approved":[{"id":"teclistamab-relapsed-or-refractory-multipl","name":"Relapsed or Refractory Multiple Myeloma (Combination Therapy)","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent","diagnosticRequired":null,"brandNameForIndication":"Bcmaxcd3"},{"id":"teclistamab-relapsed-or-refractory-multipl","name":"Relapsed or Refractory Multiple Myeloma (Monotherapy)","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody","diagnosticRequired":null,"brandNameForIndication":"Bcmaxcd3"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"blinatumomab","brandName":"blinatumomab","genericName":"blinatumomab","approvalYear":"2014","relationship":"same-target"},{"drugId":"epcoritamab","brandName":"epcoritamab","genericName":"epcoritamab","approvalYear":"2023","relationship":"same-target"},{"drugId":"muromonab-cd3","brandName":"muromonab-CD3","genericName":"muromonab-CD3","approvalYear":"1992","relationship":"same-target"},{"drugId":"talquetamab","brandName":"talquetamab","genericName":"talquetamab","approvalYear":"2023","relationship":"same-target"},{"drugId":"tebentafusp","brandName":"tebentafusp","genericName":"tebentafusp","approvalYear":"2022","relationship":"same-target"},{"drugId":"teplizumab","brandName":"teplizumab","genericName":"teplizumab","approvalYear":"2022","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT07332507","phase":"PHASE1","title":"Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma","status":"NOT_YET_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-05-29","conditions":["Recurrent Plasmablastic Lymphoma","Refractory Plasmablastic Lymphoma"],"enrollment":30,"completionDate":"2027-02-28"},{"nctId":"NCT07463807","phase":"PHASE1,PHASE2","title":"Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment","status":"NOT_YET_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-06-26","conditions":["Recurrent Multiple Myeloma","Refractory Multiple Myeloma"],"enrollment":162,"completionDate":"2026-08-31"},{"nctId":"NCT06948084","phase":"PHASE2","title":"Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse","status":"NOT_YET_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-04-29","conditions":["Recurrent Multiple Myeloma","Refractory Multiple Myeloma"],"enrollment":80,"completionDate":"2028-02-28"},{"nctId":"NCT06465316","phase":"PHASE1","title":"Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-12-06","conditions":["Recurrent Multiple Myeloma","Refractory Multiple Myeloma"],"enrollment":26,"completionDate":"2026-09-16"},{"nctId":"NCT05243797","phase":"PHASE3","title":"Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation","status":"RECRUITING","sponsor":"European Myeloma Network B.V.","startDate":"2022-09-08","conditions":["Multiple Myeloma"],"enrollment":1594,"completionDate":"2032-04"},{"nctId":"NCT07258511","phase":"PHASE3","title":"A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2026-02-04","conditions":["Multiple Myeloma"],"enrollment":400,"completionDate":"2031-09-30"},{"nctId":"NCT05083169","phase":"PHASE3","title":"A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2021-10-14","conditions":["Multiple Myeloma"],"enrollment":587,"completionDate":"2028-12-08"},{"nctId":"NCT06353022","phase":"PHASE2","title":"Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Nantes University Hospital","startDate":"2024-06-26","conditions":["Multiple Myeloma"],"enrollment":103,"completionDate":"2030-06-26"},{"nctId":"NCT07474961","phase":"PHASE4","title":"BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.","status":"NOT_YET_RECRUITING","sponsor":"Anne Louise Tølbøll Sørensen","startDate":"2027-03","conditions":["Waldenstrom Macroglobulinaemia","Multiple Myeloma"],"enrollment":400,"completionDate":"2036-12"},{"nctId":"NCT06425991","phase":"PHASE1","title":"A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2024-06-07","conditions":["Relapsed or Refractory Multiple Myeloma"],"enrollment":108,"completionDate":"2027-03-03"},{"nctId":"NCT07030517","phase":"PHASE4","title":"A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma","status":"RECRUITING","sponsor":"Johnson & Johnson Private Limited","startDate":"2025-05-22","conditions":["Multiple Myeloma"],"enrollment":75,"completionDate":"2027-06-20"},{"nctId":"NCT04722146","phase":"PHASE1","title":"A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2021-03-12","conditions":["Multiple Myeloma"],"enrollment":140,"completionDate":"2027-10-05"},{"nctId":"NCT04108195","phase":"PHASE1","title":"A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2020-02-21","conditions":["Multiple Myeloma"],"enrollment":290,"completionDate":"2027-04-07"},{"nctId":"NCT06208150","phase":"PHASE3","title":"A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2024-01-22","conditions":["Multiple Myeloma"],"enrollment":795,"completionDate":"2028-03-31"},{"nctId":"NCT06577025","phase":"PHASE2","title":"A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2024-08-20","conditions":["Multiple Myeloma"],"enrollment":43,"completionDate":"2030-09-02"},{"nctId":"NCT06285318","phase":"","title":"A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials","status":"RECRUITING","sponsor":"Janssen-Cilag Ltd.","startDate":"2023-12-18","conditions":["Relapsed/Refractory Multiple Myeloma (RRMM)"],"enrollment":900,"completionDate":"2026-07-31"},{"nctId":"NCT05552222","phase":"PHASE3","title":"A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2022-10-25","conditions":["Multiple Myeloma"],"enrollment":1590,"completionDate":"2033-10-28"},{"nctId":"NCT04696809","phase":"PHASE1,PHASE2","title":"A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2021-02-22","conditions":["Hematologic Malignancies"],"enrollment":40,"completionDate":"2026-04-22"},{"nctId":"NCT05338775","phase":"PHASE1","title":"A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2022-05-25","conditions":["Relapsed/ Refractory Multiple Myeloma"],"enrollment":74,"completionDate":"2027-05-03"},{"nctId":"NCT03145181","phase":"PHASE1,PHASE2","title":"Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","isPivotal":true,"startDate":"2017-05-16","conditions":["Hematological Malignancies"],"enrollment":302,"completionDate":"2027-05-28"},{"nctId":"NCT04557098","phase":"PHASE2","title":"A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","isPivotal":true,"startDate":"2020-09-17","conditions":["Hematological Malignancies"],"enrollment":194,"completionDate":"2027-05-28"},{"nctId":"NCT07029776","phase":"PHASE2","title":"MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma","status":"NOT_YET_RECRUITING","sponsor":"University of Arkansas","startDate":"2026-07-01","conditions":["Multiple Myeloma (MM)"],"enrollment":50,"completionDate":"2032-04-01"},{"nctId":"NCT07138209","phase":"PHASE3","title":"A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2025-11-07","conditions":["Relapsed or Refractory Multiple Myeloma"],"enrollment":228,"completionDate":"2029-12"},{"nctId":"NCT05972135","phase":"PHASE2","title":"Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma","status":"RECRUITING","sponsor":"SCRI Development Innovations, LLC","startDate":"2023-10-23","conditions":["Multiple Myeloma"],"enrollment":100,"completionDate":"2027-10"},{"nctId":"NCT06100237","phase":"PHASE2","title":"Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)","status":"RECRUITING","sponsor":"Carl Ola Landgren, MD, PhD","startDate":"2023-12-04","conditions":["Multiple Myeloma"],"enrollment":50,"completionDate":"2029-12-31"},{"nctId":"NCT05572515","phase":"PHASE3","title":"A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2023-03-29","conditions":["Relapsed or Refractory Multiple Myeloma"],"enrollment":614,"completionDate":"2031-08-31"},{"nctId":"NCT07099391","phase":"PHASE1,PHASE2","title":"A Study of Dara-RVd and Teclistamab-RVd in People With Multiple Myeloma","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2025-07-24","conditions":["Multiple Myeloma"],"enrollment":65,"completionDate":"2029-07-24"},{"nctId":"NCT07105059","phase":"PHASE1","title":"A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2025-08-08","conditions":["Multiple Myeloma"],"enrollment":18,"completionDate":"2028-08-08"},{"nctId":"NCT04586426","phase":"PHASE1,PHASE2","title":"A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2020-12-15","conditions":["Multiple Myeloma"],"enrollment":228,"completionDate":"2026-10-27"},{"nctId":"NCT05231629","phase":"PHASE2","title":"Sequential Therapy in Multiple Myeloma Guided by MRD Assessments","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2023-12-13","conditions":["Multiple Myeloma"],"enrollment":300,"completionDate":"2027-12"},{"nctId":"NCT05695508","phase":"PHASE2","title":"GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5","status":"RECRUITING","sponsor":"University of Heidelberg Medical Center","startDate":"2022-12-01","conditions":["Multiple Myeloma"],"enrollment":160,"completionDate":"2029-09-15"},{"nctId":"NCT04068597","phase":"PHASE1,PHASE2","title":"Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies","status":"RECRUITING","sponsor":"CellCentric Ltd.","startDate":"2019-08-09","conditions":["Haematological Malignancy","Acute Myeloid Leukemia","Non Hodgkin Lymphoma","Multiple Myeloma","Higher-risk Myelodysplastic Syndrome","Peripheral T Cell Lymphoma"],"enrollment":250,"completionDate":"2027-03-31"},{"nctId":"NCT05161598","phase":"","title":"Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)","status":"NO_LONGER_AVAILABLE","sponsor":"Janssen Research & Development, LLC","startDate":"","conditions":["Multiple Myeloma"],"enrollment":0,"completionDate":""},{"nctId":"NCT06251076","phase":"PHASE4","title":"Plan Development for Giving Teclistamab in the Outpatient Setting","status":"RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2024-11-19","conditions":["Multiple Myeloma","Relapsed Cancer","Refractory Cancer"],"enrollment":15,"completionDate":"2026-10"},{"nctId":"NCT07110844","phase":"PHASE2","title":"Teclistamab-Daratumumab in AL Amyloidosis","status":"RECRUITING","sponsor":"Suzanne Lentzsch, MD","startDate":"2025-11-07","conditions":["Amyloid Light-chain Amyloidosis"],"enrollment":25,"completionDate":"2033-10"},{"nctId":"NCT05932680","phase":"PHASE2","title":"Limited-duration Teclistamab","status":"RECRUITING","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2023-07-05","conditions":["Myeloma Multiple"],"enrollment":75,"completionDate":"2027-01"},{"nctId":"NCT06649695","phase":"PHASE2","title":"A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis","status":"RECRUITING","sponsor":"European Myeloma Network B.V.","startDate":"2025-07-02","conditions":["AL Amyloidosis"],"enrollment":30,"completionDate":"2028-09"},{"nctId":"NCT05572229","phase":"PHASE2","title":"Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma","status":"RECRUITING","sponsor":"University Hospital, Lille","startDate":"2023-12-21","conditions":["Multiple Myeloma"],"enrollment":74,"completionDate":"2030-09"},{"nctId":"NCT06993675","phase":"PHASE2","title":"Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)","status":"RECRUITING","sponsor":"Noffar Bar","startDate":"2025-08-21","conditions":["Multiple Myeloma"],"enrollment":50,"completionDate":"2029-08"},{"nctId":"NCT07107529","phase":"PHASE2","title":"Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.","status":"NOT_YET_RECRUITING","sponsor":"European Myeloma Network B.V.","startDate":"2025-10","conditions":["Multiple Myeloma (MM)"],"enrollment":150,"completionDate":"2034-02"},{"nctId":"NCT06588660","phase":"PHASE1","title":"ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma","status":"TERMINATED","sponsor":"University of Washington","startDate":"2024-12-18","conditions":["Recurrent Multiple Myeloma","Refractory Multiple Myeloma"],"enrollment":1,"completionDate":"2025-02-14"},{"nctId":"NCT07079423","phase":"PHASE2","title":"Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2025-06-28","conditions":["AL Amyloidosis"],"enrollment":35,"completionDate":"2027-12-31"},{"nctId":"NCT06171685","phase":"PHASE2","title":"MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM","status":"RECRUITING","sponsor":"Multiple Myeloma Research Consortium","startDate":"2024-11-17","conditions":["Relapse Multiple Myeloma","Refractory Multiple Myeloma"],"enrollment":300,"completionDate":"2030-07-31"},{"nctId":"NCT05463939","phase":"","title":"Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients","status":"APPROVED_FOR_MARKETING","sponsor":"Janssen Research & Development, LLC","startDate":"","conditions":["Relapsed or Refractory Multiple Myeloma"],"enrollment":0,"completionDate":""},{"nctId":"NCT06935162","phase":"PHASE2","title":"Teclistamab in Previously Treated AL Amyloidosis","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2025-05-21","conditions":["AL Amyloidosis"],"enrollment":30,"completionDate":"2028-12-31"},{"nctId":"NCT06062537","phase":"","title":"Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Intergroupe Francophone du Myelome","startDate":"2023-09-19","conditions":["Multiple Myeloma"],"enrollment":200,"completionDate":"2026-09"},{"nctId":"NCT06699394","phase":"NA","title":"Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis","status":"RECRUITING","sponsor":"Peking University People's Hospital","startDate":"2025-03-29","conditions":["AL Amyloidosis"],"enrollment":20,"completionDate":"2026-12-31"},{"nctId":"NCT05469893","phase":"PHASE2","title":"Immuno-PRISM (PRecision Intervention Smoldering Myeloma)","status":"RECRUITING","sponsor":"Irene Ghobrial, MD","startDate":"2022-08-10","conditions":["High-risk Smoldering Multiple Myeloma","Smoldering Multiple Myeloma","Multiple Myeloma"],"enrollment":52,"completionDate":"2030-07-31"},{"nctId":"NCT05945524","phase":"NA","title":"Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination","status":"RECRUITING","sponsor":"University Hospital, Toulouse","startDate":"2023-09-28","conditions":["Multiple Myeloma"],"enrollment":100,"completionDate":"2026-05-31"},{"nctId":"NCT06880601","phase":"PHASE2","title":"Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma","status":"NOT_YET_RECRUITING","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","startDate":"2025-11-01","conditions":["Multiple Myleoma","Multiple Myeloma in Relapse","Multiple Myeloma Refractory"],"enrollment":52,"completionDate":"2029-11-01"},{"nctId":"NCT06758375","phase":"PHASE2","title":"Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients","status":"RECRUITING","sponsor":"Hospital Universitario Dr. Jose E. Gonzalez","startDate":"2025-03-03","conditions":["Multiple Myeloma, Newly Diagnosed"],"enrollment":10,"completionDate":"2026-12-01"},{"nctId":"NCT05849610","phase":"PHASE2","title":"Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"PETHEMA Foundation","startDate":"2023-09-21","conditions":["High-Risk de Novo Multiple Myeloma"],"enrollment":30,"completionDate":"2029-07"},{"nctId":"NCT06477783","phase":"","title":"Study on the Clinical Efficacy of Teclistamab","status":"RECRUITING","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2024-12-01","conditions":["Multiple Myeloma","Hematologic Diseases"],"enrollment":100,"completionDate":"2027-09"},{"nctId":"NCT06352866","phase":"PHASE2","title":"Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM","status":"WITHDRAWN","sponsor":"Jack Khouri, MD","startDate":"2025-01-01","conditions":["Multiple Myeloma","Cytokine Release Syndrome","Refractory Multiple Myeloma","Immune Effector Cell Associated Neurotoxicity Syndrome"],"enrollment":0,"completionDate":"2025-12-01"},{"nctId":"NCT06855121","phase":"","title":"The Norwegian Immunotherapy in Multiple Myeloma Study","status":"RECRUITING","sponsor":"St. Olavs Hospital","startDate":"2025-01-15","conditions":["Myeloma Multiple","Plasma Cell Leukemia","AL Amyloidosis"],"enrollment":400,"completionDate":"2037-12-01"},{"nctId":"NCT06505369","phase":"PHASE2","title":"Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients","status":"RECRUITING","sponsor":"North Estonia Medical Centre","startDate":"2024-06-19","conditions":["Multiple Myeloma"],"enrollment":50,"completionDate":"2028-10"},{"nctId":"NCT06359067","phase":"","title":"A Real-World Study of Bispecific Antibodies in Multiple Myeloma","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-07-01","conditions":["Multiple Myeloma"],"enrollment":600,"completionDate":"2023-12-31"}],"_emaApprovals":[{"date":"2022-08-23","status":"Authorised","company":"JANSSEN-CILAG INTERNATIONAL N.V."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"pivotalTrials":["NCT03145181","NCT04557098"],"administration":{"route":"Subcutaneous","formulation":"Injection","formulations":[{"form":"INJECTION","route":"SUBCUTANEOUS","productName":"TECVAYLI"}]},"crossReferences":{"MMSL":"362676","NDDF":"019216","UNII":"54534MX6Z9","VANDF":"4041792","INN_ID":"10928","RXNORM":"2619425","UMLSCUI":"C5235398","chemblId":"CHEMBL4594505","ChEMBL_ID":"CHEMBL4594505","KEGG_DRUG":"D12177","DRUGBANK_ID":"DB16655","IUPHAR_LIGAND_ID":"12233"},"formularyStatus":[],"originalProduct":{"form":"INJECTION","route":"SUBCUTANEOUS","company":"Janssen Biotech, Inc.","brandName":"TECVAYLI","isOriginal":true,"marketingStatus":"BLA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2022-","companyName":"Johnson & Johnson","relationship":"Original Developer"},{"period":"2022","companyName":"Janssen-Cilag International N.V.","relationship":"EMA Licensee"}],"publicationCount":287,"therapeuticAreas":["Oncology"],"_revenueScrapedAt":"2026-04-08 13:57:35.835065+00","biosimilarFilings":[],"originalDeveloper":"Janssen Biotech","recentPublications":[{"date":"2026 Mar 8","pmid":"41892182","title":"Analyzing Real-World Infection Risk in Multiple Myeloma Patients Receiving Teclistamab.","journal":"Current oncology (Toronto, Ont.)"},{"date":"2026 Mar 26","pmid":"41886245","title":"Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Receiving Teclistamab: A Panel Chart Review Study.","journal":"Oncology and therapy"},{"date":"2026 Mar 26","pmid":"41886220","title":"Revised Recommendations for Restarting Teclistamab Following Dose Delays: Insights from the MajesTEC-1 Study on Clinical Safety, and from Simulated Pharmacokinetics and Cytokine Dynamics.","journal":"Targeted oncology"},{"date":"2026 Mar 26","pmid":"41882240","title":"Recurrent cytokine release syndrome in patients receiving bispecific antibody therapy for multiple myeloma: a case series.","journal":"Annals of hematology"},{"date":"2026 Mar 25","pmid":"41881461","title":"Outpatient Delivery of Step-Up Doses to Rapidly Initiate Monthly Doses of Bispecific Antibodies in Multiple Myeloma.","journal":"European journal of haematology"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Johnson & Johnson","companyId":"johnson-johnson","modality":"Monoclonal antibody","firstApprovalDate":"2022","enrichmentLevel":4,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-10-25T00:00:00.000Z","mah":"JANSSEN BIOTECH","brand_name_local":null,"application_number":""},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"2022-10-25T00:00:00.000Z","mah":"JANSSEN BIOTECH","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"2022-10-25T00:00:00.000Z","mah":"JANSSEN BIOTECH","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"2022-10-25T00:00:00.000Z","mah":"JANSSEN BIOTECH","brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"2022-10-25T00:00:00.000Z","mah":"JANSSEN BIOTECH","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"2022-10-25T00:00:00.000Z","mah":"JANSSEN BIOTECH","brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-12-02T00:00:00.000Z","mah":"JANSSEN BIOTECH","brand_name_local":null,"application_number":"BLA761291"},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""}],"trialStats":{"total":27,"withResults":0},"validation":{"fieldsValidated":4,"lastValidatedAt":"2026-04-20T00:29:37.060193+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}