Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 235 mg fosnetupitant/0.25 mg palonosetron ); Injection (intravenous; 235 mg fosnetupitant/0.25 mg palonosetron); Capsule (oral; 300 mg netupitant/0.5 mg palonosetron) |
Drug Class | Serotonin-3 (5-HT3) receptor antagonists and substance P/neurokinin-1 (NK-1) receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Akynzeo capsule 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.
- 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.
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Summary
- Akynzeo (netupitant or fosnetupitant and palonosetron) 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 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. 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 phases after cancer chemotherapy.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- In patients undergoing Highly Emetogenic Chemotherapy (HEC), the combination of fosnetupitant + palonosetron showed higher efficacy (810 of 1000; RR 1.15, 95% CI 0.97 to 1.37) compared to aprepitant + granisetron in completely controlling vomiting during the overall treatment phase (1 to 5 days). Aprepitant + palonosetron also demonstrated greater efficacy (753 of 1000; RR 1.07, 95% CI 1.98 to 1.18) but with low certainty.
- For patients receiving Moderately Emetogenic Chemotherapy (MEC), aprepitant + palonosetron (716 of 1000; RR 1.29, 95% CI 1.00 to 1.66) and netupitant + palonosetron (694 of 1000; RR 1.25, 95% CI 0.92 to 1.70) were more effective in controlling vomiting compared to granisetron alone, with both findings associated with low certainty.
- In the context of Highly Emetogenic Chemotherapy (HEC), 35 of 1000 participants experienced serious adverse events (SAEs) with aprepitant + granisetron. Fosaprepitant + ondansetron (8 of 1000; RR 0.23, 95% CI 0.05 to 1.07; low certainty) and netupitant + palonosetron (9 of 1000; RR 0.27, 95% CI 0.05 to 1.58; low certainty) had fewer SAEs compared to aprepitant + granisetron.
- For Moderately Emetogenic Chemotherapy (MEC), granisetron had an estimated 153 of 1000 participants experiencing SAEs, with rolapitant + granisetron potentially leading to more SAEs compared to granisetron alone (176 of 1000; RR 1.15, 95% CI 0.88 to 1.50; low certainty).
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Akynzeo (netupitant/fosnetupitant and palonosetron) Prescribing Information | 2023 | Helsinn Therapeutics (U.S.), Inc., Iselin, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta‐analysis. | 2021 | Cochrane Database of Systematic Reviews |
Netupitant/Palonosetron: a Review in Chemotherapy-Induced Nausea and Vomiting. | 2021 | Drugs |
Effectiveness of antiemetic regimens for highly emetogenic chemotherapy-induced nausea and vomiting: a systematic review and network meta-analysis. | 2019 | The Oncologist |
Neurokinin-1 receptor antagonists: review of their role for the prevention of chemotherapy-induced nausea and vomiting in adults. | 2019 | Expert Review of Clinical Pharmacology |