{"id":"netupitant-and-palonosetron","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":["7 DRUG INTERACTIONS CYP3A4 Substrates: inhibition of CYP3A4 by netupitant can result in increased plasma concentrations of the concomitant drug for 6 days after single dosage administration of AKYNZEO; avoid concomitant CYP3A4 substrates for one week, if feasible. If not avoidable, consider dose reduction of the CYP3A4 substrate ( 7.1 ) CYP3A4 Inducers (e.g., rifampin): decreased plasma concentrations of netupitant; avoid use ( 7.2 ) 7.1 Effects of AKYNZEO on Other Drugs Interaction with CYP3A4 Substrates Netupitant is a moderate inhibitor of CYP3A4. AKYNZEO should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. A single oral dose of netupitant 300 mg significantly inhibits CYP3A4 for 6 days. Avoid concomitant use of drugs that are CYP3A4 substrates for one week, if feasible. If not avoidable, consider dose reduction of CYP3A4 substrates. Dexamethasone A single oral dose of netupitant 300 mg or a single fosnetupitant infusion of 235 mg increased the systemic exposure of concomitant dexamethasone more than 2-fold on Days 2 and 4. Administer a reduced dose of dexamethasone with AKYNZEO [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 )] . Midazolam When administered with netupitant, the systemic exposure to midazolam was significantly increased. Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering these drugs with AKYNZEO [see Clinical Pharmacology ( 12.3 )] . Chemotherapeutic Agents The systemic exposure of chemotherapy agents metabolized by CYP3A4 can increase when administered with AKYNZEO. Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine [see Clinical Pharmacology ( 12.3 )] . Caution and monitoring for chemotherapeutic related adverse reactions are advised in patients receiving chemotherapy agents metabolized primarily by CYP3A4. Oral Contraceptives There is no clinically significant effect of AKYNZEO on the efficacy of oral contraceptives containing levonorgestrel and ethinyl estradiol [see Clinical Pharmacology ( 12.3 )] . Warfarin Although it was predicted that co-administration of intravenous AKYNZEO with warfarin would not substantially increase the systemic exposure to S-warfarin (CYP2C9 substrate), the active enantiomer, the effects of AKYNZEO for injection and AKYNZEO capsules on INR and prothrombin time have not been studied. Monitor INR and adjust the dosage of warfarin, as needed with concomitant use of AKYNZEO, to maintain the target INR range. 7.2 Effects of Other Drugs on AKYNZEO Netupitant is mainly metabolized by CYP3A4. Palonosetron is mainly metabolized by CYP2D6 and to a lesser extent by CYP3A4 and CYP1A2. CYP3A4 Inducers Avoid concomitant use of AKYNZEO in patients who are chronically using a strong CYP3A4 inducer such as rifampin. A strong CYP3A inducer can decrease the efficacy of AKYNZEO by substantially reducing plasma concentrations of the netupitant component [see Clinical Pharmacology ( 12.3 )] . CYP3A4 Inhibitors Concomitant use of AKYNZEO with a strong CYP3A4 inhibitor (e.g., ketoconazole) can increase the systemic exposure to the netupitant component of AKYNZEO. However, no dosage adjustment is necessary for single dose administration of AKYNZEO [see Clinical Pharmacology ( 12.3 )] . 7.3 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). If symptoms occur, discontinue AKYNZEO and initiate supportive treatment [see Warnings and Precautions ( 5.2 )]."],"commonSideEffects":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are found elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema ( 6.1 ) The safety profile of AKYNZEO for injection was generally similar to that seen with AKYNZEO capsules. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact HELSINN at 1-844-357-4668 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. AKYNZEO Capsules The overall safety of AKYNZEO capsules was evaluated in 1538 cancer patients and healthy subjects in clinical trials. The data described below reflect exposure to AKYNZEO in 1169 cancer patients, receiving at least one cycle of cancer chemotherapy in 3 active-controlled trials [see Clinical Studies ( 14 .1 )] , including 782 exposed to AKYNZEO for at least 4 cycles and 321 exposed for at least 6 cycles, up to a maximum of 12 cycles of chemotherapy. The median age was 55, 79% were female, 83% were White, 13% were Asian, and 4% were Hispanic. All patients received a single oral dose of AKYNZEO 1 hour prior to the start of each chemotherapy cycle. In all studies, dexamethasone was co-administered with AKYNZEO [see Clinical Studies ( 14.1 ), Table 16 and Table 18 ]. Cisplatin Based Highly Emetogenic Chemotherapy In a single-cycle study of patients receiving cisplatin based highly emetogenic chemotherapy, 136 patients were treated with AKYNZEO. Table 5 shows adverse reactions reported at an incidence of at least 3% and for which the AKYNZEO rate exceeded palonosetron alone. Table 5: Adverse Reactions Occurring in ≥3% of Cancer Patients Receiving AKYNZEO capsules and Cisplatin Based Highly Emetogenic Chemotherapy (Cycle 1) Adverse Reactions AKYNZEO netupitant 300 mg/ palonosetron 0.5 mg (N=136) Palonosetron 0.5 mg (N=136) Dyspepsia 4% 2% Fatigue 4% 2% Constipation 3% 1% Erythema 3% 2% Anthracyclines and Cyclophosphamide Based Chemotherapy In a study of patients receiving anthracycline and cyclophosphamide based chemotherapy, 725 patients were treated with AKYNZEO capsules during Cycle 1, and 635 of these patients continued for up to 8 cycles in a multiple-cycle extension. Table 6 shows adverse reactions reported at an incidence of at least 3% and for which the AKYNZEO capsules rate exceeded palonosetron alone during Cycle 1. The adverse reaction profile in subsequent cycles was similar to that observed in Cycle 1. Table 6: Adverse Reactions Occurring in ≥3% of Cancer Patients Receiving AKYNZEO capsules and Anthracyclines and Cyclophosphamide Based Chemotherapy (Cycle 1) Adverse Reactions AKYNZEO netupitant 300 mg/ palonosetron 0.5 mg (N=725) Palonosetron 0.5 mg (N=725) Headache 9% 7% Asthenia 8% 7% Fatigue 7% 5% In addition to the adverse reactions shown above, there were reports of concomitant elevations of transaminases greater than 3 times the upper limit of normal and total bilirubin in both arms of the two trials that compared AKYNZEO capsules to oral palonosetron, and the frequency of these elevations was comparable between treatment groups. See Table 7. Table 7: Liver Function Laboratory Abnormalities ULN = upper limit of normal Laboratory Changes AKYNZEO netupitant 300 mg/ palonosetron 0.5 mg N=861 Palonosetron 0.5 mg N=861 AST > 3 x ULN and/or ALT > 3 x ULN with Total Bilirubin > ULN 3 (0.3%) 5 (0.6%) AST > 10 x ULN and/or ALT > 10 x ULN with Total Bilirubin > ULN - 2 (0.2%) AST > 3 x ULN and/or ALT > 3 x ULN with Total Bilirubin ≥ 2 x ULN 1 (0.1%) 1 (0.1%) In a multi-cycle safety study of 412 patients, the safety profile of"],"contraindications":["4 CONTRAINDICATIONS None. None ( 4 )"]},"status":"discontinued","trials":["NCT04669132","NCT03204279","NCT06200168","NCT04817189","NCT02517021","NCT03097588","NCT03386617","NCT04201769","NCT06102447","NCT04486157","NCT01339260","NCT03040726","NCT03649230","NCT07132749","NCT03668639","NCT06065722","NCT06726291","NCT03831633","NCT01376297","NCT06840769","NCT06331520","NCT03008213","NCT06952920","NCT03403712","NCT04362449","NCT07254416","NCT05081687","NCT03367572","NCT03862144"],"aliases":["Akynzeo"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"Netupitant and Palonosetron","companyId":"helsinn-healthcare-sa","ecosystem":[],"mechanism":{"drugClass":"Substance P/Neurokinin-1 Receptor Antagonist [EPC]","explanation":"1 INDICATIONS AND USAGE AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. ( 1 )","oneSentence":"12.1 Mechanism of Action Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK-1) receptors. Palonosetron is a 5-HT 3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly when certain agents, such as cisplatin, are used. 5-HT 3 receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema. Chemotherapeutic agents produce nausea and vomiting by stimulating the release of serotonin from the enterochromaffin cells of the small intestine. Serotonin then activates 5-HT 3 receptors located on vagal afferents to initiate the vomiting reflex. The development of acute emesis is known to depend on serotonin and its 5-HT 3 receptors have been demonstrated to selectively stimulate the emetic response. Delayed emesis has been largely associated with the activation of tachykinin family neurokinin 1 (NK-1) receptors (broadly distributed in the central and peripheral nervous systems) by substance P. As shown in in vitro and in vivo studies, netupitant inhibits substance P mediated responses."},"commercial":null,"references":[],"biosimilars":[],"companyName":"Helsinn Healthcare SA","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"Netupitant and Palonosetron","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04669132","phase":"Phase 2","title":"Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer","status":"COMPLETED","sponsor":"Instituto Brasileiro de Controle do Cancer","isPivotal":false,"enrollment":50,"indication":"Nausea Post Chemotherapy","completionDate":"2022-01-17"},{"nctId":"NCT03204279","phase":"Phase 2","title":"A Multicenter Multinational Randomized Double Blind PK/PD Dose-finding Study of Oral Netupitant Given With Oral Palonosetron in Pediatric Cancer Patients for Prevention of Nausea and Vomiting Associat","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","isPivotal":false,"enrollment":67,"indication":"Chemotherapy-induced Nausea and Vomiting (CINV)","completionDate":"2019-09-30"},{"nctId":"NCT06200168","phase":"Phase 3","title":"A Study on Electroacupuncture Combined With Olanzapine-contained Four-drug Antiemetic Therapy for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting in Patients With Breast C","status":"RECRUITING","sponsor":"Jiuda Zhao","isPivotal":true,"enrollment":370,"indication":"Electroacupuncture, Olanzapine-contained Four-drug Antiemetic","completionDate":"2026-12-31"},{"nctId":"NCT04817189","phase":"Phase 4","title":"MyRisk: Efficacy and Safety Evaluation of Oral Akynzeo® in Patients Receiving MEC at High Risk of Developing CINV Based on a Prediction Tool: A Multinational and Multicenter Study","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","isPivotal":false,"enrollment":414,"indication":"Chemotherapy-induced Nausea and Vomiting","completionDate":"2024-07-02"},{"nctId":"NCT02517021","phase":"Phase 3","title":"A Phase 3, Multicenter, Randomized, Double-blind, Active Control Study to Evaluate the Safety and Efficacy of IV Pro-netupitant/Palonosetron (260 mg/0.25 mg) Combination for the Prevention of Chemothe","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","isPivotal":true,"enrollment":405,"indication":"Chemotherapy-Induced Nausea and Vomiting","completionDate":"2016-08"},{"nctId":"NCT03097588","phase":"Phase 2","title":"A Phase II Clinical Trial of NEPA (Netupitant/Palonosetron) for Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patient Receiving the BEAM Conditioning Regimen Prior to Hematopoietic ","status":"COMPLETED","sponsor":"OHSU Knight Cancer Institute","isPivotal":false,"enrollment":43,"indication":"Malignant Neoplasm","completionDate":"2020-03-20"},{"nctId":"NCT03386617","phase":"Phase 2","title":"Open Label Single Arm Study for NEPA [Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron] in Hong Kong Oncology Patients Receiving (Neo)-Adjuvant Chemotherapy Treatment Consists","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chinese University of Hong Kong","isPivotal":false,"enrollment":55,"indication":"Breast Cancer","completionDate":"2028-12-31"},{"nctId":"NCT04201769","phase":"Phase 3","title":"A Standard Regimen of Dexamethasone in Comparison to Two Dex-sparing Regimens in Addition to NEPA in Preventing CINV in naïve NSCLC Patients to be Treated With Cisplatin Based Chemotherapy: a Three-ar","status":"UNKNOWN","sponsor":"Consorzio Oncotech","isPivotal":true,"enrollment":261,"indication":"Chemotherapy-induced Nausea and Vomiting","completionDate":"2020-04"},{"nctId":"NCT06102447","phase":"NA","title":"Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma","status":"UNKNOWN","sponsor":"Sichuan Cancer Hospital and Research Institute","isPivotal":false,"enrollment":36,"indication":"Head and Neck Squamous Cell Carcinoma (HNSCC)","completionDate":"2026-01-01"},{"nctId":"NCT04486157","phase":"Phase 1","title":"A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Sub","status":"COMPLETED","sponsor":"HK inno.N Corporation","isPivotal":false,"enrollment":44,"indication":"Healthy","completionDate":"2021-05-10"},{"nctId":"NCT01339260","phase":"Phase 3","title":"A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","isPivotal":true,"enrollment":1455,"indication":"Chemotherapy-Induced Nausea and Vomiting","completionDate":""},{"nctId":"NCT03040726","phase":"Phase 2","title":"Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","isPivotal":true,"enrollment":53,"indication":"Malignant Neoplasm, Nausea","completionDate":"2022-02-14"},{"nctId":"NCT03649230","phase":"N/A","title":"A Phase IV, Real World Observational Study On The Use Of Akynzeo® (Netupitant/Palonosetron) For The Prevention Of Nausea and Vomiting in Oncology Patients Receiving Highly Emetogenic Chemotherapy (HEC","status":"COMPLETED","sponsor":"Purdue Pharma, Canada","isPivotal":false,"enrollment":207,"indication":"Chemotherapy-Induced Nausea and Vomiting","completionDate":"2020-01-30"},{"nctId":"NCT07132749","phase":"N/A","title":"A Prospective, Observational, Multicenter Cohort Study Evaluating the Efficacy and Safety of NEPA (Netupitant/Palonosetron) in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated Wi","status":"ENROLLING_BY_INVITATION","sponsor":"Yeon Hee Park","isPivotal":false,"enrollment":100,"indication":"Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd, Patients With HER2-low Advanced Breast Cancer Treated With T-DXd","completionDate":"2026-09-30"},{"nctId":"NCT03668639","phase":"Phase 2","title":"A Study to Investigate the Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone in Patients Receiving Concomitant Chemo-radiotherapy With Weekly Cisplatin for at Least Five Weeks","status":"UNKNOWN","sponsor":"Christina Ruhlmann","isPivotal":true,"enrollment":80,"indication":"Chemotherapy-induced Nausea and Vomiting, Adverse Event","completionDate":"2023-04-15"},{"nctId":"NCT06065722","phase":"Phase 2","title":"Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy","status":"UNKNOWN","sponsor":"Simon Williamson Clinic","isPivotal":false,"enrollment":100,"indication":"Chemotherapy Induced Nausea and Vomiting","completionDate":"2023-12-31"},{"nctId":"NCT06726291","phase":"Phase 4","title":"Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer Treated With Taxane- Platinum Combination Chemotherapy. NOEME Study.","status":"RECRUITING","sponsor":"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","isPivotal":false,"enrollment":84,"indication":"Endometrial Cancer","completionDate":"2026-06-30"},{"nctId":"NCT03831633","phase":"Phase 4","title":"A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving","status":"UNKNOWN","sponsor":"VIFORFRANCE","isPivotal":false,"enrollment":426,"indication":"Oncology","completionDate":"2019-07-31"},{"nctId":"NCT01376297","phase":"Phase 3","title":"A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemothera","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","isPivotal":true,"enrollment":413,"indication":"Chemotherapy-Induced Nausea and Vomiting","completionDate":""},{"nctId":"NCT06840769","phase":"Phase 1","title":"A Phase I, Open Label, Single Dose, Two Parts Study in Male and Female Healthy Subjects to Assess the Safety and Pharmacokinetics of Fosnetupitant 235 mg Administered as IV Bolus and of Derived Netupi","status":"TERMINATED","sponsor":"Helsinn Healthcare SA","isPivotal":false,"enrollment":50,"indication":"Healthy Volunteers","completionDate":"2023-10-23"},{"nctId":"NCT06331520","phase":"Phase 3","title":"Dexamethasone-sparing Based on Netupitant/Palonosetron(NEPA) With Olanzapine for the Effect of Chemotherapy-induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: a Randomiz","status":"NOT_YET_RECRUITING","sponsor":"Fudan University","isPivotal":true,"enrollment":627,"indication":"Chemotherapy-induced Nausea and Vomiting, Highly Emetogenic Chemotherapy","completionDate":"2026-05-01"},{"nctId":"NCT03008213","phase":"Phase 2","title":"Fixed Dose Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory Chemotherapy-Induced Nausea and Vomiting","status":"TERMINATED","sponsor":"Joseph Ma","isPivotal":false,"enrollment":4,"indication":"Chemotherapy Induced Nausea Vomiting","completionDate":"2018-01-22"},{"nctId":"NCT06952920","phase":"Phase 3","title":"Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer","status":"RECRUITING","sponsor":"Jiuda Zhao","isPivotal":true,"enrollment":388,"indication":"Standard Quadruple Antiemetic Therapy, Electroacupuncture","completionDate":"2028-06-30"},{"nctId":"NCT03403712","phase":"Phase 3","title":"A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 ","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","isPivotal":true,"enrollment":404,"indication":"Chemotherapy-induced Nausea and Vomiting","completionDate":"2018-09-19"},{"nctId":"NCT04362449","phase":"Phase 2","title":"A Prospective Study of Tolerance Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration","status":"UNKNOWN","sponsor":"Imperial College Healthcare NHS Trust","isPivotal":false,"enrollment":30,"indication":"Gallbladder Cancer","completionDate":"2023-02-02"},{"nctId":"NCT07254416","phase":"Phase 4","title":"To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients","status":"NOT_YET_RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","isPivotal":false,"enrollment":120,"indication":"Breast Cancer Patients Treated With T-DXd","completionDate":"2027-06-30"},{"nctId":"NCT05081687","phase":"Phase 3","title":"A Prospective Randomized Controlled Trial of Total Neo-adjuvant Therapy vs Conventional Chemo-radiation Aiming at Increasing Rates of Clinical Complete Response in Locally Advanced Rectal Cancer","status":"UNKNOWN","sponsor":"Hospital Israelita Albert Einstein","isPivotal":true,"enrollment":150,"indication":"Colorectal Neoplasms","completionDate":"2023-12-30"},{"nctId":"NCT03367572","phase":"Phase 3","title":"Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer","status":"COMPLETED","sponsor":"University of Rochester NCORP Research Base","isPivotal":true,"enrollment":1363,"indication":"Breast Carcinoma","completionDate":"2024-04-13"},{"nctId":"NCT03862144","phase":"Phase 2","title":"One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemo","status":"COMPLETED","sponsor":"Consorzio Oncotech","isPivotal":false,"enrollment":150,"indication":"Chemotherapy-induced Nausea and Vomiting","completionDate":"2017-04-03"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"ORAL","dosage_text":"2 DOSAGE AND ADMINISTRATION Recommended Dosage AKYNZEO capsules: The recommended dosage is one AKYNZEO capsule administered 1 hour prior to the start of chemotherapy, with or without food. ( 2.1 ) Preparation and Administration AKYNZEO injection is supplied either as a Ready-to-Use (with hanger) vial or a To-be-Diluted vial. (2.2) AKYNZEO for injection requires dilution prior to administration. ( 2.3 ) See full prescribing information for information on preparation, administration, and incompatibilities for each product. (2.2, 2.3, 2.4 ) 2.1 Recommended Dosage The recommended dosages of AKYNZEO and dexamethasone in adults for the prevention of nausea and vomiting associated with administration of emetogenic chemotherapy are shown in Table 1. AKYNZEO capsules can be taken with or without food. Table 1: Antiemetic Treatment Regimen Treatment Regimen Day 1 Days 2 to 4 Highly Emetogenic Chemotherapy, including Cisplatin-Based Chemotherapy AKYNZEO capsules 1 capsule of AKYNZEO 1 hour before chemotherapy Dexamethasone 8 mg once a day Dexamethasone 12 mg 30 minutes before chemotherapy AKYNZEO for injection and AKYNZEO injection 1 vial of AKYNZEO Infuse over 30 minutes starting 30 minutes before chemotherapy [see Dosage and Administration (2.2)] Dexamethasone 8 mg once a day Dexamethasone 12 mg 30 minutes before chemotherapy Anthracyclines and Cyclophosphamide-Based Chemotherapy and Chemotherapy Not Considered Highly Emetogenic AKYNZEO capsules 1 capsule of AKYNZEO 1 hour before chemotherapy None Dexamethasone 12 mg 30 minutes before chemotherapy 2.2 Preparation and Administration of AKYNZEO Injection (Ready-to-Use and To-be-Diluted) AKYNZEO injection is supplied as either a Ready-to-Use (with hanger) vial or a To-be-Diluted vial. AKYNZEO injection (Ready-to-Use; with hanger) See Table 2 for preparation instructions of AKYNZEO injection (Ready-to-Use) for intravenous infusion. AKYNZEO injection (Ready-to-Use) does not require dilution prior to administration. Table 2: Preparation and Administration of AKYNZEO Injection (Ready-to-Use) for Intravenous Infusion Step 1 Before administration, inspect the solution for particulate matter and discoloration. Discard the vial if particulates and/or discoloration are observed. Step 2 Using aseptic technique, insert a vented intravenous set through the septum of the vial. Once the stopper is punctured, use immediately. Step 3 To administer, invert and hang the vial utilizing the strap affixed to the bottom of the vial. Step 4 Administer over 30 minutes as an intravenous infusion. At the end of the infusion, flush the infusion line with 0.9% Sodium Chloride Injection, USP or with 5% Dextrose injection, USP to ensure complete drug administration. AKYNZEO injection (Ready-to-Use) contains no antimicrobial preservatives and is intended for single use only. Compatibility AKYNZEO injection (Ready-to-Use) is compatible with intravenous dexamethasone sodium phosphate which can be infused simultaneously. Do not add dexamethasone sodium phosphate to the AKYNZEO injection (Ready-to-Use) vial. Stability and Storage Use immediately once the stopper is punctured. AKYNZEO Injection (To-be-Diluted) See Table 3 for preparation instructions of AKYNZEO injection (To-be-Diluted) for intravenous infusion with dilution. Table 3: Preparation and Administration of AKYNZEO Injection (To-be-Diluted) for Intravenous Infusion Step 1 Before administration, inspect the solution for particulate matter and discoloration. Discard the vial if particulates and/or discoloration are observed. Step 2 Aseptically prepare an infusion vial or bag filled with 30 mL of 5% Dextrose injection, USP or 0.9% Sodium Chloride injection, USP. Step 3 Aseptically withdraw the entire volume of solution from the AKYNZEO vial (20 mL) and transfer it into the infusion vial or bag containing 30 mL of 5% Dextrose injection, USP or 0.9% Sodium Chloride injection, USP to yield a total volume of 50 mL. Step 4 Gently invert the vial or bag until complete dis"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}