{"id":"alemtuzumab","rwe":[{"pmid":"41871072","year":"2026","title":"Nonmyeloablative pentostatin-cyclophosphamide preconditioning improves rates of engraftment in adults undergoing haploidentical HCT for sickle cell disease.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"41823332","year":"2026","title":"Analysis of herpes zoster cases in multiple sclerosis patients treated with disease-modifying drugs: insights from the EudraVigilance database.","finding":"","journal":"Neurologia i neurochirurgia polska","studyType":"Clinical Study"},{"pmid":"41792300","year":"2026","title":"Anti-thymocyte globulin (ATG)- or alemtuzumab-based graft-versus-host disease prophylaxis in reduced-intensity conditioning allogeneic hematopoietic cell transplantation (HCT) for patients 40 years and older with acute lymphoblastic leukemia in first complete remission: a study from the EBMT Acute Leukemia Working Party.","finding":"","journal":"Bone marrow transplantation","studyType":"Clinical Study"},{"pmid":"41785834","year":"2026","title":"Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system.","finding":"","journal":"Multiple sclerosis and related disorders","studyType":"Clinical Study"},{"pmid":"41782490","year":"2026","title":"Alemtuzumab Induction in Septuagenarians Undergoing Deceased Donor Kidney Transplantation.","finding":"","journal":"Clinical transplantation","studyType":"Clinical Study"}],"_fda":{"id":"db03295a-9939-43bb-92c5-768721d27a8b","set_id":"4f5f7255-7abc-4328-bd1a-ceaf139ef3e0","openfda":{"nui":["N0000175079","N0000175659"],"unii":["3A189DH42V"],"route":["INTRAVENOUS"],"rxcui":["828265","828267"],"spl_id":["db03295a-9939-43bb-92c5-768721d27a8b"],"brand_name":["Campath"],"spl_set_id":["4f5f7255-7abc-4328-bd1a-ceaf139ef3e0"],"package_ndc":["58468-0357-1","58468-0357-3"],"product_ndc":["58468-0357"],"generic_name":["ALEMTUZUMAB"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ALEMTUZUMAB"],"pharm_class_epc":["CD52-directed Cytolytic Antibody [EPC]"],"pharm_class_moa":["CD52-directed Antibody Interactions [MoA]"],"manufacturer_name":["Genzyme Corporation"],"application_number":["BLA103948"],"is_original_packager":[true]},"version":"21","pregnancy":["8.1 Pregnancy Risk Summary Based on findings from animal studies, CAMPATH may cause fetal harm when administered to a pregnant woman. Available data from published cohort studies in pregnant women are insufficient to establish a CAMPATH-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Alemtuzumab was embryolethal in pregnant huCD52 transgenic mice when administered during organogenesis (see Data ) . Human IgG antibodies are known to cross the placental barrier; therefore, CAMPATH may be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. Infants born to pregnant women treated with CAMPATH may be at increased risk of infection (see Clinical Considerations ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Clinical Considerations Fetal/Neonatal adverse reactions Monoclonal antibodies are transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Consider the risks and benefits of administering live or live-attenuated vaccines to infants exposed to CAMPATH in utero [see Warnings and Precautions (5.3 , 5.4) ] . Data Animal data When alemtuzumab was administered to pregnant huCD52 transgenic mice during organogenesis (gestation days [GD] 6–10 or GD 11–15) at intravenous doses of 3 or 10 mg/kg, no teratogenic effects were observed. However, there was an increase in embryolethality (increased postimplantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during GD 11–15. In a separate study in pregnant huCD52 transgenic mice, administration of alemtuzumab during organogenesis (GD 6–10 or GD 11–15) at intravenous doses of 3 or 10 mg/kg, decreases in B-lymphocyte and T-lymphocyte populations were observed in the offspring at both doses tested. In pregnant huCD52 transgenic mice administered alemtuzumab at intravenous doses of 3 or 10 mg/kg/day throughout gestation and lactation, there was an increase in pup deaths during the lactation period at 10 mg/kg. Decreases in T-lymphocyte and B-lymphocyte populations and in antibody response were observed in offspring at both doses tested."],"overdosage":["10 OVERDOSAGE Across all clinical experience, the reported maximum single dose received was 90 mg. Bone marrow aplasia, infections, or severe infusion-related reactions occurred in patients who received a dose higher than recommended. One patient who received an 80 mg dose intravenously experienced acute bronchospasm, cough, and dyspnea, followed by anuria and death. Another patient received two 90 mg doses intravenously one day apart during the second week of treatment and experienced a rapid onset of bone marrow aplasia. There is no known specific antidote for CAMPATH overdosage. Discontinue CAMPATH and provide supportive therapy."],"description":["11 DESCRIPTION Alemtuzumab, a CD52-directed cytolytic antibody, is a recombinant DNA-derived humanized monoclonal antibody (CAMPATH-1H). CAMPATH-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (CAMPATH-1G). The CAMPATH-1H antibody has an approximate molecular weight of 150 kD. CAMPATH is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. CAMPATH (alemtuzumab) injection is a sterile, clear, colorless, isotonic solution (pH 6.8–7.4) in a single-dose vial for intravenous use. Each single-dose vial of CAMPATH contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING CAMPATH (alemtuzumab) is supplied in clear glass single-dose vial containing 30 mg of alemtuzumab in 1 mL of solution. Each carton contains three CAMPATH vials (NDC 58468-0357-3) or one CAMPATH vial (NDC 58468-0357-1). Store CAMPATH at 2°C to 8°C (36°F to 46°F). Do not freeze. If accidentally frozen, thaw at 2°C to 8°C before administration. Protect from direct sunlight."],"boxed_warning":["WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions. ( 5.2 ) Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections. ( 2.2 , 5.3 ) Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving CAMPATH. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions : CAMPATH administration can result in serious, including fatal, infusion-related reactions. Carefully monitor patients during infusions and withhold CAMPATH for Grade 3 or 4 infusion-related reactions. Gradually escalate CAMPATH to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Immunosuppression/Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving CAMPATH. Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] ."],"geriatric_use":["8.5 Geriatric Use Of 147 previously untreated B-CLL patients treated with CAMPATH, 35% were ≥ age 65 and 4% were ≥ age 75. Of 149 previously treated patients with B-CLL, 44% were ≥65 years of age and 10% were ≥75 years of age. Clinical studies of CAMPATH did not include sufficient number of subjects age 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness of CAMPATH have not been established in pediatric patients."],"effective_time":"20251105","clinical_studies":["14 CLINICAL STUDIES 14.1 Previously Untreated B-CLL Patients CAMPATH was evaluated in an open-label, randomized (1:1) active-controlled study in previously untreated patients with B-CLL, Rai Stage I–IV, with evidence of progressive disease requiring therapy. Patients received either CAMPATH 30 mg intravenously 3 times per week for a maximum of 12 weeks or chlorambucil 40 mg/m 2 orally once every 28 days for a maximum of 12 cycles. Of the 297 patients randomized, the median age was 60 years, 72% were male, 99% were Caucasian, 96% had a WHO performance status 0–1, 23% had maximum lymph node diameter ≥5 cm, 34% were Rai Stage III/IV, and 8% were treated in the U.S. Patients randomized to receive CAMPATH experienced longer progression free survival (PFS) compared to those randomized to receive chlorambucil (median PFS 14.6 months vs. 11.7 months, respectively). The overall response rates were 83% and 55% (p <0.0001) and the complete response rates were 24% and 2% (p <0.0001) for CAMPATH and chlorambucil arms, respectively. The Kaplan-Meier curve for PFS is shown in Figure 1. Figure 1: Progression Free Survival in Previously Untreated B-CLL Patients Log-rank test adjusted for Rai Stage (I–II vs. III–IV). Figure 1 14.2 Previously Treated B-CLL Patients CAMPATH was evaluated in three multicenter, open-label, single-arm studies of 149 patients with B-CLL previously treated with alkylating agents, fludarabine, or other chemotherapies. Patients were treated with the recommended dose of CAMPATH 30 mg intravenously 3 times per week for up to 12 weeks. Partial response rates of 21% to 31% and complete response rates of 0% to 2% were observed."],"pharmacodynamics":["12.2 Pharmacodynamics Cardiac Electrophysiology The effect of multiple doses of alemtuzumab (12 mg/day for 5 days) on the QTc interval was evaluated in a single-arm study in 53 patients without malignancy. No large changes in the mean QTc interval (i.e., >20 ms) were detected in the study. A mean increase in heart rate of 22 to 26 beats/min was observed for at least 2 hours following the initial infusion of alemtuzumab. This increase in heart rate was not observed with subsequent doses."],"pharmacokinetics":["12.3 Pharmacokinetics CAMPATH pharmacokinetics were characterized in a study of 30 previously treated B-CLL patients in whom CAMPATH was administered at the recommended dose and schedule. After 12 weeks of dosing, patients exhibited a 7-fold increase in mean AUC. Distribution After the last 30 mg dose, the mean volume of distribution at steady-state was 0.18 L/kg (range 0.1 to 0.4 L/kg). Elimination CAMPATH pharmacokinetics displayed nonlinear elimination kinetics. Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i.e., loss of CD52 receptors in the periphery). Mean half-life was 11 hours (range 2 to 32 hours) after the first 30 mg dose and was 6 days (range 1 to 14 days) after the last 30 mg dose. Specific Populations The effects of renal or hepatic impairment on the pharmacokinetics of CAMPATH have not been studied."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Cytopenias [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Immunosuppression/Infections [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥10%): cytopenias, infusion-related reactions, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-877-4-CAMPATH (1-877-422-6728) 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. The data below reflect exposure to CAMPATH in 296 patients with CLL of whom 147 were previously untreated and 149 received at least 2 prior chemotherapy regimens. The median duration of exposure was 11.7 weeks for previously untreated patients and 8 weeks for previously treated patients. The most common adverse reactions with CAMPATH are: infusion-related reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), infections (CMV viremia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety). The most common serious adverse reactions are cytopenias, infusion-related reactions, and immunosuppression/infections. Lymphopenia Severe lymphopenia and a rapid and sustained decrease in lymphocyte subsets occurred in previously untreated and previously treated patients following administration of CAMPATH. In previously untreated patients, the median CD4+ was 0 cells/μL at one month after treatment and 238 cells/μL [25%–75% interquartile range 115 to 418 cells/μL at 6 months post treatment [see Warnings and Precautions (5.3) ] . Neutropenia In previously untreated patients, the incidence of Grade 3 or 4 neutropenia was 42% with a median time to onset of 31 days and a median duration of 37 days. In previously treated patients, the incidence of Grade 3 or 4 neutropenia was 64% with a median duration of 28 days. Ten percent of previously untreated patients and 17% of previously treated patients received granulocyte colony stimulating factors. Anemia In previously untreated patients, the incidence of Grade 3 or 4 anemia was 12% with a median time to onset of 31 days and a median duration of 8 days. In previously treated patients, the incidence of Grade 3 or 4 anemia was 38%. Seventeen percent of previously untreated patients and 66% of previously treated patients received either erythropoiesis stimulating agents, transfusions or both. Thrombocytopenia In previously untreated patients, the incidence of Grade 3 or 4 thrombocytopenia was 14% with a median time to onset of 9 days and a median duration of 14 days. In previously treated patients, the incidence of Grade 3 or 4 thrombocytopenia was 52% with a median duration of 21 days. Autoimmune thrombocytopenia was reported in 2% of previously treated patients with one fatality. Infusion-Related Reactions Infusion-related reactions, which included pyrexia, chills, hypotension, urticaria, and dyspnea, were common. Grade 3 and 4 pyrexia and/or chills occurred in approximately 10% of previously untreated patients and in approximately 35% of previously treated patients. The occurrence of infusion-related reactions was greatest during the initial week of treatment and decreased with subsequent doses of CAMPATH. All patients were pretreated with antipyretics and antihistamines; additionally, 43% of previously untreated patients received glucocorticoid pre-treatment. Infections In the study of previously untreated patients, patients were tested weekly for CMV using a PCR assay from initiation through completion of therapy, and every 2 weeks for the first 2 months following therapy. CMV infection occurred in 16% (23/147) of previously untreated patients; approximately one-third of these infections were serious or life threatening. In studies of previously treated patients in which routine CMV surveillance was not required, CMV infection was documented in 6% (9/149) of patients; nearly all of these infections were serious or life threatening. Other infections were reported in approximately 50% of patients across all studies. Grade 3 to 5 sepsis ranged from 3% to 10% across studies and was higher in previously treated patients. Grade 3 to 4 febrile neutropenia ranged from 5% to 10% across studies and was higher in previously treated patients. Infection-related fatalities occurred in 2% of previously untreated patients and 16% of previously treated patients. There were 198 episodes of other infection in 109 previously untreated patients; 16% were bacterial, 7% were fungal, 4% were other viral, and in 73% the organism was not identified. Cardiac Cardiac dysrhythmias occurred in approximately 14% of previously untreated patients. The majority were tachycardias and were temporally associated with infusion; dysrhythmias were Grade 3 or 4 in 1% of patients. Previously Untreated Patients Table 1 contains selected adverse reactions observed in 294 patients randomized (1:1) to receive CAMPATH or chlorambucil as first line therapy for B-CLL. CAMPATH was administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks. The median duration of therapy was 11.7 weeks with a median weekly dose of 82 mg (25%–75% interquartile range: 69–90 mg). Table 1: Per Patient Incidence of Selected Adverse reactions occurring at a higher relative frequency in the CAMPATH arm Adverse Reactions in Treatment Naive B-CLL Patients CAMPATH (n=147) Chlorambucil (n=147) All Grades NCI CTC version 2.0 for adverse reactions; NCI CTCAE version 3.0 for laboratory values % Grades 3–4 % All Grades % Grades 3–4 % Blood and Lymphatic System Disorders Lymphopenia 97 97 9 1 Neutropenia 77 42 51 26 Anemia 76 13 54 18 Thrombocytopenia 71 13 70 14 General Disorders and Administration Site Conditions Pyrexia 69 10 11 1 Chills 53 3 1 0 Infections and Infestations CMV viremia CMV viremia (without evidence of symptoms) includes both cases of single PCR positive test results and of confirmed CMV viremia (≥2 occasions in consecutive samples 1 week apart). For the latter, ganciclovir (or equivalent) was initiated per protocol. 55 4 8 0 CMV infection 16 5 0 0 Other infections 74 21 65 10 Skin and Subcutaneous Tissue Disorders Urticaria 16 2 1 0 Rash 13 1 4 0 Erythema 4 0 1 0 Vascular Disorders Hypotension 16 1 0 0 Hypertension 14 5 2 1 Nervous System Disorders Headache 14 1 8 0 Tremor 3 0 1 0 Respiratory, Thoracic and Mediastinal Disorders Dyspnea 14 4 7 3 Gastrointestinal Disorders Diarrhea 10 1 4 0 Psychiatric Disorders Insomnia 10 0 3 0 Anxiety 8 0 1 0 Cardiac Disorders Tachycardia 10 0 1 0 Previously Treated Patients Additional safety information was obtained from 3 single arm studies of 149 previously treated patients with CLL administered 30 mg CAMPATH intravenously three times weekly for 4 to 12 weeks (median cumulative dose 673 mg [range 2–1106 mg]; median duration of therapy 8.0 weeks). Adverse reactions in these studies not listed in Table 1 that occurred at an incidence rate of >5% were fatigue, nausea, emesis, musculoskeletal pain, anorexia, dysesthesia, mucositis, and bronchospasm. 6.2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies with the incidence of antibodies to other alemtuzumab products may be misleading. Using an ELISA assay, anti-human antibodies (HAHA) were detected in 11 of 133 (8.3%) previously untreated patients. In addition, two patients were weakly positive for neutralizing activity. Limited data suggest that the anti-CAMPATH antibodies did not adversely affect tumor response. Four of 211 (1.9%) previously treated patients were found to have antibodies to CAMPATH following treatment. 6.3 Postmarketing Experience CAMPATH The following adverse reactions have been identified during postapproval use of CAMPATH. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General Disorders and Administration Site Conditions: Fatal infusion-related reactions. Cardiovascular Disorders: Congestive heart failure, cardiomyopathy, decreased ejection fraction (some patients had been previously treated with cardiotoxic agents). Cerebrovascular Disorders: Cervicocephalic arterial dissection, stroke, including hemorrhagic and ischemic stroke. Gastrointestinal Disorders: Acute acalculous cholecystitis. Immune System Disorders: Goodpasture's syndrome, Graves' disease, aplastic anemia, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, serum sickness, fatal transfusion associated graft versus host disease, hemophagocytic lymphohistiocytosis (HLH). Infections: Epstein-Barr virus (EBV) infection, progressive multifocal leukoencephalopathy (PML), reactivation of latent viruses. Metabolism and Nutrition Disorders: Tumor lysis syndrome. Neoplasms: EBV-associated lymphoproliferative disorder. Nervous System Disorders: Optic neuropathy. Renal and Urinary Disorders: Glomerular nephropathies. Other Alemtuzumab Products The following adverse reactions have been identified during postapproval use of another alemtuzumab product. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Endocrine Disorders: Hypothyroidism, hyperthyroidism, and thyroiditis. Nervous System Disorders : Autoimmune encephalitis."],"contraindications":["4 CONTRAINDICATIONS None. None ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS No formal drug interaction studies have been performed with CAMPATH."],"mechanism_of_action":["12.1 Mechanism of Action CAMPATH binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of CAMPATH to the leukemic cells."],"storage_and_handling":["Store CAMPATH at 2°C to 8°C (36°F to 46°F). Do not freeze. If accidentally frozen, thaw at 2°C to 8°C before administration. Protect from direct sunlight."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action CAMPATH binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of CAMPATH to the leukemic cells. 12.2 Pharmacodynamics Cardiac Electrophysiology The effect of multiple doses of alemtuzumab (12 mg/day for 5 days) on the QTc interval was evaluated in a single-arm study in 53 patients without malignancy. No large changes in the mean QTc interval (i.e., >20 ms) were detected in the study. A mean increase in heart rate of 22 to 26 beats/min was observed for at least 2 hours following the initial infusion of alemtuzumab. This increase in heart rate was not observed with subsequent doses. 12.3 Pharmacokinetics CAMPATH pharmacokinetics were characterized in a study of 30 previously treated B-CLL patients in whom CAMPATH was administered at the recommended dose and schedule. After 12 weeks of dosing, patients exhibited a 7-fold increase in mean AUC. Distribution After the last 30 mg dose, the mean volume of distribution at steady-state was 0.18 L/kg (range 0.1 to 0.4 L/kg). Elimination CAMPATH pharmacokinetics displayed nonlinear elimination kinetics. Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i.e., loss of CD52 receptors in the periphery). Mean half-life was 11 hours (range 2 to 32 hours) after the first 30 mg dose and was 6 days (range 1 to 14 days) after the last 30 mg dose. Specific Populations The effects of renal or hepatic impairment on the pharmacokinetics of CAMPATH have not been studied."],"indications_and_usage":["1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Cytopenias : Obtain complete blood counts (CBC) and platelet counts at weekly intervals during therapy and CD4 counts after therapy until recovery to ≥200 cells/µL. Withhold for severe cytopenias. Discontinue for autoimmune or severe hematologic adverse reactions. ( 2.2 , 5.1 ) Immunosuppression/Infections : CAMPATH induces severe and prolonged lymphopenia and increases risk of infection. If a serious infection occurs, withhold treatment until infection resolves. ( 5.3 ) Immunization : Do not administer live viral vaccines to patients who have recently received CAMPATH. ( 5.4 ) 5.1 Cytopenias Severe, including fatal, autoimmune anemia and thrombocytopenia, and prolonged myelosuppression have been reported in patients receiving CAMPATH. In addition, hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia have been reported after treatment with CAMPATH at the recommended dose. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia. Withhold CAMPATH for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia) [see Dosage and Administration (2.3) ] . No data exist on the safety of CAMPATH resumption in patients with autoimmune cytopenias or marrow aplasia [see Adverse Reactions (6.1) ] . Obtain complete blood counts (CBC) at weekly intervals during CAMPATH therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Assess CD4+ counts after treatment until recovery to ≥200 cells/µL [see Dosage and Administration (2.3) and Adverse Reactions (6) ] . 5.2 Infusion-Related Reactions Adverse reactions occurring during or shortly after CAMPATH infusion include pyrexia, chills/rigors, nausea, hypotension, urticaria, dyspnea, rash, emesis, and bronchospasm [see Adverse Reactions (6.1) ] . In clinical trials, the frequency of infusion-related reactions was highest in the first week of treatment. Monitor for the signs and symptoms listed above and withhold infusion for Grade 3 or 4 infusion-related reactions. The following serious, including fatal, infusion-related reactions have been identified in postmarketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock. Initiate CAMPATH according to the recommended dose-escalation scheme [see Dosage and Administration (2.1) ] . Premedicate patients with an antihistamine and acetaminophen prior to each dose. Institute appropriate medical management (e.g., glucocorticoids, epinephrine, meperidine) for infusion-related reactions as needed [see Dosage and Administration (2.2) ] . If therapy is interrupted for 7 or more days, reinstitute CAMPATH with gradual dose escalation [see Dosage and Administration (2.1) ]. 5.3 Immunosuppression/Infections CAMPATH treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections [see Adverse Reactions (6.1) ] . Administer PCP and herpes viral prophylaxis during treatment with CAMPATH and for a minimum of 2 months after completion of CAMPATH or until the CD4+ count is ≥200 cells/µL, whichever occurs later [see Dosage and Administration (2.2) ] . Prophylaxis does not eliminate these infections. Routinely monitor patients for CMV infection during treatment with CAMPATH and for at least 2 months following completion of CAMPATH. Withhold CAMPATH for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia (defined as polymerase chain reaction [PCR] positive CMV in ≥2 consecutive samples obtained 1 week apart). Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia. Epstein-Barr virus (EBV) infection, including severe and fatal EBV-associated hepatitis, has been reported in patients who received CAMPATH. Monitor for sign and symptoms of EBV infections. Withhold CAMPATH for EBV reactivation or severe infection. Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion. In patients who received CAMPATH as initial therapy, recovery of CD4+ counts to ≥200 cells/µL occurred by 6 months following completion of CAMPATH; however, at 2 months post treatment, the median was 183 cells/µL. In previously treated patients who received CAMPATH, the median time to recovery of CD4+ counts to ≥200 cells/µL was 2 months; however, full recovery (to baseline) of CD4+ and CD8+ counts may take more than 12 months [see Adverse Reactions (6) ] . 5.4 Immunization The safety of immunization with live viral vaccines following CAMPATH therapy has not been studied. Do not administer live viral vaccines to patients or infants born to patients receiving CAMPATH. The ability to generate an immune response to any vaccine following CAMPATH therapy has not been studied."],"clinical_studies_table":["
Figure 1: Progression Free Survival in Previously Untreated B-CLL PatientsLog-rank test adjusted for Rai Stage (I–II vs. III–IV).
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the carcinogenic or genotoxic potential of CAMPATH have not been conducted. In fertility studies, alemtuzumab (3 or 10 mg/kg intravenously) was administered to huCD52 transgenic male mice on 5 consecutive days prior to cohabitation with untreated wild-type females. No effect on fertility or reproductive performance was observed. However, adverse effects on sperm parameters (including abnormal morphology [detached/no head] and reduced total count and motility) were observed at both doses tested. When alemtuzumab (3 or 10 mg/kg intravenously) was administered to huCD52 transgenic female mice for 5 consecutive days prior to cohabitation with untreated wild-type males, there was a decrease in the average number of corpora lutea and implantation sites and an increase in postimplantation loss, resulting in fewer viable embryos at the higher dose tested."],"adverse_reactions_table":["
Table 1: Per Patient Incidence of SelectedAdverse reactions occurring at a higher relative frequency in the CAMPATH arm Adverse Reactions in Treatment Naive B-CLL Patients
CAMPATH (n=147)Chlorambucil (n=147)
All GradesNCI CTC version 2.0 for adverse reactions; NCI CTCAE version 3.0 for laboratory values %Grades 3–4 %All Grades %Grades 3–4 %
Blood and Lymphatic System DisordersLymphopenia979791
Neutropenia77425126
Anemia76135418
Thrombocytopenia71137014
General Disorders and Administration Site ConditionsPyrexia6910111
Chills53310
Infections and InfestationsCMV viremiaCMV viremia (without evidence of symptoms) includes both cases of single PCR positive test results and of confirmed CMV viremia (≥2 occasions in consecutive samples 1 week apart). For the latter, ganciclovir (or equivalent) was initiated per protocol.55480
CMV infection16500
Other infections74216510
Skin and Subcutaneous Tissue DisordersUrticaria16210
Rash13140
Erythema4010
Vascular DisordersHypotension16100
Hypertension14521
Nervous System Disorders Headache14180
Tremor3010
Respiratory, Thoracic and Mediastinal DisordersDyspnea14473
Gastrointestinal DisordersDiarrhea10140
Psychiatric DisordersInsomnia10030
Anxiety8010
Cardiac DisordersTachycardia10010
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Cytopenias Advise patients to report any signs or symptoms such as bleeding, easy bruising, petechiae or purpura, pallor, weakness or fatigue [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Infusion-Related Reactions Advise patients of the signs and symptoms of infusion-related reactions and of the need to take premedications as prescribed [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Immunosuppression/Infections Advise patients to immediately report symptoms of infection (e.g., pyrexia) and to take prophylactic anti-infectives for PCP (trimethoprim/sulfamethoxazole DS or equivalent) and for herpes virus (famciclovir or equivalent) as prescribed [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] . Advise patients that irradiation of blood products is required [see Warnings and Precautions (5.3) ] . Immunization Advise patients that they should not be immunized with live viral vaccines if they have recently been treated with CAMPATH. Advise females with infants exposed to CAMPATH in utero to inform the pediatrician of the exposure [see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1 , 8.3) ] . Advise female patients of reproductive potential to use effective contraception during treatment with CAMPATH and for 3 months after the final dose [see Use in Specific Populations (8.1 , 8.3) ] . Lactation Advise females not to breastfeed during treatment with CAMPATH and for 3 months after the final dose [see Use in Specific Populations (8.2) ] . Infertility Advise females and males of reproductive potential that CAMPATH may impair fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ] . Glomerular Nephropathies Advise patients on signs and symptoms of glomerular nephropathies that may occur months to years after receiving CAMPATH [see Adverse Reactions (6.2) ] ."],"spl_unclassified_section":["Manufactured and distributed by: Genzyme Corporation, Cambridge, MA 02141 A SANOFI COMPANY US License Number: 1596 CAMPATH is a registered trademark of Genzyme Corporation. ©2023 Genzyme Corporation."],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Administer as an intravenous infusion over 2 hours. ( 2.1 ) Escalate to recommended dose of 30 mg/day three times per week for 12 weeks. ( 2.1 ) Premedicate with oral antihistamine and acetaminophen. ( 2.2 ) 2.1 Dosing Schedule and Administration Administer as an intravenous infusion over 2 hours. Do not administer as intravenous push or bolus. Recommended Dosing Regimen Gradually escalate to the maximum recommended single dose of 30 mg. Escalation is required at initiation of dosing or if dosing is held ≥7 days during treatment. Escalation to 30 mg ordinarily can be accomplished in 3 to 7 days. Escalation Strategy: – Administer 3 mg daily until infusion-related reactions are ≤ Grade 2 [see Adverse Reactions (6.1) ] . – Then administer 10 mg daily until infusion-related reactions are ≤ Grade 2. – Then administer 30 mg/day three times per week on alternate days (e.g., Mon-Wed-Fri). The total duration of therapy, including dose escalation, is 12 weeks. Single doses of greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia. 2.2 Recommended Concomitant Medications Premedicate with diphenhydramine (50 mg) and acetaminophen (500–1000 mg) 30 minutes prior to first infusion and each dose escalation. Institute appropriate medical management (e.g., glucocorticoids, epinephrine, meperidine) for infusion-related reactions as needed [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Administer trimethoprim/sulfamethoxazole double strength (DS) twice daily 3 times per week (or equivalent) as Pneumocystis jirovecii pneumonia (PCP) prophylaxis. Administer famciclovir 250 mg BID or equivalent as herpetic prophylaxis. Continue PCP and herpes viral prophylaxis for a minimum of 2 months after completion of CAMPATH or until the CD4+ count is ≥200 cells/µL, whichever occurs later [see Warnings and Precautions (5.3) ] . 2.3 Dosage Modification Withhold CAMPATH during serious infection or other serious adverse reactions until resolution. Discontinue CAMPATH for autoimmune anemia or autoimmune thrombocytopenia. There are no dose modifications recommended for lymphopenia. Dose Modification for Neutropenia or Thrombocytopenia [see Warnings and Precautions (5.1) ] Hematologic Values Dosage Modification If the delay between dosing is ≥7 days, initiate therapy at CAMPATH 3 mg and escalate to 10 mg and then to 30 mg as tolerated [see Dosage and Administration (2.1) ] . ANC <250/μL and/or platelet count ≤25,000/μL For first occurrence: Withhold CAMPATH therapy. Resume CAMPATH at 30 mg when ANC ≥500/μL and platelet count ≥50,000/μL. For second occurrence: Withhold CAMPATH therapy. Resume CAMPATH at 10 mg when ANC ≥500/μL and platelet count ≥50,000/μL. For third occurrence: Discontinue CAMPATH therapy. ≥50% decrease from baseline in patients initiating therapy with a baseline ANC ≤250/μL and/or a baseline platelet count ≤25,000/μL For first occurrence: Withhold CAMPATH therapy. Resume CAMPATH at 30 mg upon return to baseline value(s). For second occurrence: Withhold CAMPATH therapy. Resume CAMPATH at 10 mg upon return to baseline value(s). For third occurrence: Discontinue CAMPATH therapy. 2.4 Preparation and Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, discard the vial. DO NOT SHAKE VIAL . Use aseptic technique during the preparation and administration of CAMPATH. Withdraw the necessary amount of CAMPATH from the vial into a syringe. To prepare the 3 mg dose, withdraw 0.1 mL into a 1 mL syringe calibrated in increments of 0.01 mL. To prepare the 10 mg dose, withdraw 0.33 mL into a 1 mL syringe calibrated in increments of 0.01 mL. To prepare the 30 mg dose, withdraw 1 mL in either a 1 mL or 3 mL syringe calibrated in 0.1 mL increments. Inject syringe contents into 100 mL sterile 0.9% Sodium Chloride USP or 5% Dextrose in Water USP. Gently invert the bag to mix the solution . Discard syringe. The vial contains no preservatives and is intended for single use only. DISCARD VIAL including any unused portion after withdrawal of dose. Use within 8 hours after dilution. Store diluted CAMPATH at room temperature between 15°C to 30°C (59°F to 86°F) or refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. 2.5 Incompatibilities CAMPATH is compatible with polyvinylchloride (PVC) bags and PVC or polyethylene-lined PVC administration sets. Do not add or simultaneously infuse other drug substances through the same intravenous line."],"spl_product_data_elements":["Campath ALEMTUZUMAB ALEMTUZUMAB ALEMTUZUMAB SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM POTASSIUM CHLORIDE MONOBASIC POTASSIUM PHOSPHATE POLYSORBATE 80 EDETATE DISODIUM"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Injection: 30 mg/1 mL as a clear, colorless solution in single-dose vial Injection: 30 mg/1 mL single-dose vial ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies, CAMPATH may cause fetal harm when administered to a pregnant woman. Available data from published cohort studies in pregnant women are insufficient to establish a CAMPATH-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Alemtuzumab was embryolethal in pregnant huCD52 transgenic mice when administered during organogenesis (see Data ) . Human IgG antibodies are known to cross the placental barrier; therefore, CAMPATH may be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. Infants born to pregnant women treated with CAMPATH may be at increased risk of infection (see Clinical Considerations ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Clinical Considerations Fetal/Neonatal adverse reactions Monoclonal antibodies are transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Consider the risks and benefits of administering live or live-attenuated vaccines to infants exposed to CAMPATH in utero [see Warnings and Precautions (5.3 , 5.4) ] . Data Animal data When alemtuzumab was administered to pregnant huCD52 transgenic mice during organogenesis (gestation days [GD] 6–10 or GD 11–15) at intravenous doses of 3 or 10 mg/kg, no teratogenic effects were observed. However, there was an increase in embryolethality (increased postimplantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during GD 11–15. In a separate study in pregnant huCD52 transgenic mice, administration of alemtuzumab during organogenesis (GD 6–10 or GD 11–15) at intravenous doses of 3 or 10 mg/kg, decreases in B-lymphocyte and T-lymphocyte populations were observed in the offspring at both doses tested. In pregnant huCD52 transgenic mice administered alemtuzumab at intravenous doses of 3 or 10 mg/kg/day throughout gestation and lactation, there was an increase in pup deaths during the lactation period at 10 mg/kg. Decreases in T-lymphocyte and B-lymphocyte populations and in antibody response were observed in offspring at both doses tested. 8.2 Lactation Risk Summary There are no data on the presence of alemtuzumab in human milk, effects on milk production, or the breastfed child. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to alemtuzumab are unknown. Alemtuzumab was detected in the milk of lactating huCD52 transgenic mice administered alemtuzumab (see Data ) . Maternal IgG is known to be present in human milk and when a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions from CAMPATH in a breastfed child, including reduced lymphocyte counts, advise lactating women not to breastfeed during treatment with CAMPATH and for at least 3 months following the last dose. Data Alemtuzumab was detected in the milk of lactating huCD52 transgenic mice following intravenous administration of alemtuzumab at a dose of 10 mg/kg on postpartum days 8–12. Serum levels of alemtuzumab were similar in lactating mice and offspring on postpartum day 13 and were associated with evidence of pharmacological activity (decrease in lymphocyte counts) in the offspring. 8.3 Females and Males of Reproductive Potential CAMPATH may cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) ] . Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating CAMPATH therapy. Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with CAMPATH and for at least 3 months after the last dose. Infertility Based on findings from animal studies, alemtuzumab may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology (13.1) ]. The reversibility of the effect on fertility is unknown. 8.4 Pediatric Use Safety and effectiveness of CAMPATH have not been established in pediatric patients. 8.5 Geriatric Use Of 147 previously untreated B-CLL patients treated with CAMPATH, 35% were ≥ age 65 and 4% were ≥ age 75. Of 149 previously treated patients with B-CLL, 44% were ≥65 years of age and 10% were ≥75 years of age. Clinical studies of CAMPATH did not include sufficient number of subjects age 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients."],"dosage_and_administration_table":["
Dose Modification for Neutropenia or Thrombocytopenia [see Warnings and Precautions (5.1)]
Hematologic ValuesDosage ModificationIf the delay between dosing is ≥7 days, initiate therapy at CAMPATH 3 mg and escalate to 10 mg and then to 30 mg as tolerated [see Dosage and Administration (2.1)].
ANC <250/μL and/or platelet count ≤25,000/μL
For first occurrence:Withhold CAMPATH therapy. Resume CAMPATH at 30 mg when ANC ≥500/μL and platelet count ≥50,000/μL.
For second occurrence:Withhold CAMPATH therapy. Resume CAMPATH at 10 mg when ANC ≥500/μL and platelet count ≥50,000/μL.
For third occurrence:Discontinue CAMPATH therapy.
≥50% decrease from baseline in patients initiating therapy with a baseline ANC ≤250/μL and/or a baseline platelet count ≤25,000/μL
For first occurrence:Withhold CAMPATH therapy. Resume CAMPATH at 30 mg upon return to baseline value(s).
For second occurrence:Withhold CAMPATH therapy. Resume CAMPATH at 10 mg upon return to baseline value(s).
For third occurrence:Discontinue CAMPATH therapy.
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 1 Vial Carton NDC 58468-0357-1 Rx only Campath ® alemtuzumab Injection 30 mg/mL For Intravenous Infusion After Dilution Sterile – No U.S. Standard of Potency One single-dose vial Discard unused portion sanofi PRINCIPAL DISPLAY PANEL - 1 Vial Carton","PRINCIPAL DISPLAY PANEL - 3 Vial Carton NDC 58468-0357-3 Rx only Campath ® alemtuzumab Injection 30 mg/mL For Intravenous Infusion After Dilution Sterile – No U.S. Standard of Potency Three single-dose vials Discard unused portion sanofi PRINCIPAL DISPLAY PANEL - 3 Vial Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the carcinogenic or genotoxic potential of CAMPATH have not been conducted. In fertility studies, alemtuzumab (3 or 10 mg/kg intravenously) was administered to huCD52 transgenic male mice on 5 consecutive days prior to cohabitation with untreated wild-type females. No effect on fertility or reproductive performance was observed. However, adverse effects on sperm parameters (including abnormal morphology [detached/no head] and reduced total count and motility) were observed at both doses tested. When alemtuzumab (3 or 10 mg/kg intravenously) was administered to huCD52 transgenic female mice for 5 consecutive days prior to cohabitation with untreated wild-type males, there was a decrease in the average number of corpora lutea and implantation sites and an increase in postimplantation loss, resulting in fewer viable embryos at the higher dose tested."]},"tags":[{"label":"CD52-directed Cytolytic Antibody","category":"class"},{"label":"Monoclonal Antibody","category":"modality"},{"label":"CAMPATH-1 antigen","category":"target"},{"label":"CD52","category":"gene"},{"label":"L04AA34","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Conditioning treatment prior to allogeneic haematopoietic stem cell transplant","category":"indication"},{"label":"Recurrent chronic lymphocytic leukemia","category":"indication"},{"label":"Refractory chronic lymphocytic leukemia","category":"indication"},{"label":"Relapsing remitting multiple sclerosis","category":"indication"},{"label":"Genzyme","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Immunological","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions. ( 5.2 ) Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections. ( 2.2 , 5.3 ) Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving CAMPATH. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions : CAMPATH administration can result in serious, including fatal, infusion-related reactions. Carefully monitor patients during infusions and withhold CAMPATH for Grade 3 or 4 infusion-related reactions. Gradually escalate CAMPATH to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Immunosuppression/Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving CAMPATH. Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] ."],"safetySignals":[{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1882 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1860 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"1764 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1560 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"1188 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1180 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1002 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"982 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"938 reports"},{"date":"","signal":"MULTIPLE SCLEROSIS RELAPSE","source":"FDA FAERS","actionTaken":"898 reports"}],"commonSideEffects":[{"effect":"Neutropenia","drugRate":"64%","severity":"common","_validated":true},{"effect":"Cytopenias","drugRate":"reported","severity":"common"},{"effect":"Infections","drugRate":"reported","severity":"common"},{"effect":"Infusion-related reactions","drugRate":"reported","severity":"common"},{"effect":"Nausea","drugRate":"reported","severity":"common"},{"effect":"Emesis","drugRate":"reported","severity":"common"},{"effect":"Diarrhea","drugRate":"reported","severity":"common"},{"effect":"Insomnia","drugRate":"reported","severity":"common"},{"effect":"Lymphopenia","drugRate":"reported","severity":"serious"},{"effect":"Immunosuppression/infections","drugRate":"reported","severity":"serious"},{"effect":"Anemia","drugRate":"38%","severity":"common","_validated":true},{"effect":"Thrombocytopenia","drugRate":"52%","severity":"common","_validated":true},{"effect":"Pyrexia","drugRate":"35%","severity":"common","_validated":true},{"effect":"Chills","drugRate":"35%","severity":"common","_validated":true},{"effect":"Hypotension","drugRate":"reported","severity":"common"},{"effect":"Urticaria","drugRate":"reported","severity":"common"},{"effect":"Rash","drugRate":"reported","severity":"common"},{"effect":"Tachycardia","drugRate":"reported","severity":"common"},{"effect":"Dyspnea","drugRate":"reported","severity":"common"},{"effect":"CMV infection","drugRate":"16%","severity":"serious","_validated":true},{"effect":"CMV viremia","drugRate":"reported","severity":"serious"},{"effect":"Sepsis","drugRate":"reported","severity":"serious"},{"effect":"Febrile neutropenia","drugRate":"reported","severity":"serious"},{"effect":"Cardiac dysrhythmias","drugRate":"14%","severity":"mild","_validated":true}],"specialPopulations":{"Pregnancy":"May cause fetal harm. Women of childbearing potential should use effective contraception during and for months after course of treatment with LEMTRADA. There are no adequate data on the developmental risk associated with the use of LEMTRADA in pregnant women. LEMTRADA was embryolethal in pregnant huCD52 transgenic mice when administered during organogenesis. Auto-antibodies may develop after administration of LEMTRADA. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves disease has been reported.","Geriatric use":"Of 147 previously untreated B-CLL patients treated with CAMPATH, 35% were >= age 65 and 4% were >= age 75. Of 149 previously treated patients with B-CLL, 44% were >=65 years of age and 10% were >=75 years of age. Clinical studies of CAMPATH did not include sufficient number of subjects age 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients less than 17 years of age have not been established. Use of LEMTRADA is not recommended in pediatric patients due to the risks of autoimmunity, infusion reactions, and stroke, and because it may increase the risk of malignancies (thyroid, melanoma, lymphoproliferative disorders, and lymphoma)."}},"trials":[],"aliases":[],"company":"Sanofi","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ALEMTUZUMAB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:31:45.474017+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Alemtuzumab","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:31:52.957513+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:31:51.468194+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALEMTUZUMAB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:31:51.831190+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:44.362219+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:44.362256+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 ","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:44.362269+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":"2026-04-20T03:31:53.399413+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: CAMPATH-1 antigen inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:31:52.957414+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201587/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:31:52.611980+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA103948","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:44.362274+00:00"}},"allNames":"campath","offLabel":[],"synonyms":["campath","alemtuzumab","lemtrada"],"timeline":[{"date":"2001-05-07","type":"positive","source":"DrugCentral","milestone":"FDA approval (Genzyme)"},{"date":"2014-09-26","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Sanofi K.K.)"}],"aiSummary":"Campath, also known as Alemtuzumab, is an antibody that inhibits the CAMPATH-1 antigen. It is used in various clinical trials for conditions such as Severe Sickle Cell Disease, Bone Marrow Failure Syndromes, and Immunologic Disorders, often as part of a reduced intensity conditioning regimen or graft-versus-host disease prophylaxis.","brandName":"Campath","ecosystem":[{"indication":"Conditioning treatment prior to allogeneic haematopoietic stem cell transplant","otherDrugs":[],"globalPrevalence":null},{"indication":"Recurrent chronic lymphocytic leukemia","otherDrugs":[],"globalPrevalence":null},{"indication":"Refractory chronic lymphocytic leukemia","otherDrugs":[],"globalPrevalence":null},{"indication":"Relapsing remitting multiple sclerosis","otherDrugs":[{"name":"cladribine","slug":"cladribine","company":""},{"name":"daclizumab","slug":"daclizumab","company":"Hoffman-La Roche"},{"name":"dimethyl fumarate","slug":"dimethyl-fumarate","company":"Biogen Idec Inc"},{"name":"fingolimod","slug":"fingolimod","company":"Novartis"}],"globalPrevalence":null}],"mechanism":{"target":"CAMPATH-1 antigen","novelty":"Follow-on","targets":[{"gene":"CD52","source":"DrugCentral","target":"CAMPATH-1 antigen","protein":"CAMPATH-1 antigen"}],"moaClass":"CD52-directed Antibody Interactions","modality":"Monoclonal Antibody","drugClass":"CD52-directed Cytolytic Antibody [EPC]","explanation":"The precise mechanism by which alemtuzumab exerts its therapeutic effects in multiple sclerosis is unknown but is presumed to involve binding to CD52, cell surface antigen present on and lymphocytes, and on natural killer cells, monocytes, and macrophages. Following cell surface binding to and lymphocytes, alemtuzumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.","oneSentence":"Campath works by binding to a specific protein on the surface of immune cells, marking them for destruction.","technicalDetail":"Campath is a monoclonal antibody that binds to the CD52 antigen, a protein expressed on the surface of mature lymphocytes, leading to their depletion through mechanisms involving complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Alemtuzumab","title":"Alemtuzumab","extract":"Alemtuzumab, sold under the brand names Campath and Lemtrada among others, is a medication used to treat chronic lymphocytic leukemia and multiple sclerosis. In chronic lymphocytic leukemia, it has been used as both a first line and second line treatment. It is given by injection into a vein.","wiki_history":"== History ==\nThe origins of alemtuzumab date back to Campath-1 which was derived from the rat antibodies raised against human lymphocyte proteins by Herman Waldmann and colleagues in 1983. The name Campath derives from the pathology department of Cambridge University.\n\nInitially, Campath-1 was not ideal for therapy because patients could, in theory, react against the foreign rat protein determinants of the antibody. To circumvent this problem, Greg Winter and his colleagues humanised Campath-1, by extracting the hypervariable loops that had specificity for CD52 and grafting them onto a human antibody framework. This became known as Campath-1H and serves as the basis for alemtuzumab.\n\nWhile alemtuzumab started life as a laboratory tool for understanding the immune system, within a short time it was clinically investigated for use to improve the success of bone marrow transplants and as a treatment for leukaemia, lymphoma, vasculitis, organ transplants, rheumatoid arthritis and multiple sclerosis.","wiki_society_and_culture":"== Society and culture ==\n=== Economics ===\nCampath as a medication was first approved for B-cell chronic lymphocytic leukemia in 2001. It is marketed by Genzyme, which acquired the worldwide rights from Bayer AG in 2009. Genzyme was bought by Sanofi in 2011. In August/September 2012 Campath was withdrawn from the markets in the US and EU. This was done to prevent off-label use of the drug to treat multiple sclerosis and to prepare for a relaunch under the brand name Lemtrada, with a different dosage aimed at multiple sclerosis treatment, this is expected to be much higher-priced.\n\nIn February 2011, Sanofi-Aventis, since renamed Sanofi, acquired Genzyme, the manufacturer of alemtuzumab. The acquisition was delayed by a dispute between the two companies regarding the value of alemtuzumab.\n\nIn August 2012, Genzyme surrendered the license for all presentations of alemtuzumab, pending regulatory approval to reintroduce it as a treatment for multiple sclerosis. Concerns that Genzyme would later bring to market the same product at a much higher price proved correct.\n\n=== Names ===\nAlemtuzumab is the international nonproprietary name."},"commercial":{"launchDate":"2001","_launchSource":"DrugCentral (FDA 2001-05-07, GENZYME)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4909","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ALEMTUZUMAB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALEMTUZUMAB","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Alemtuzumab","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T08:35:43.847265","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:31:56.435745+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"muromonab-CD3","drugSlug":"muromonab-cd3","fdaApproval":"1992-09-14","relationship":"same-class"},{"drugName":"mycophenolic 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