Netupitant or fosnetupitant and palonosetron

(Akynzeo®)

Akynzeo®

Drug updated on 5/17/2024

Dosage FormInjection (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 ClassSerotonin-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
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  • Netupitant or fosnetupitant and palonosetron (Akynzeo) are indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including highly emetogenic chemotherapy. Akynzeo combines a neurokinin-1 (NK1) receptor antagonist (netupitant/fosnetupitant) with a serotonin-3 (5-HT3) receptor antagonist (palonosetron), providing efficacy during both the acute and delayed phases.
  • Four studies were analyzed to gather information about Akynzeo's safety, effectiveness, and considerations for specific subgroups. In these studies, Akynzeo demonstrated robust control over vomiting when compared to other combinations such as aprepitant + granisetron.
  • In terms of the safety profile among antiemetics used in highly emetogenic chemotherapy settings, Akynzeo exhibited a low risk of causing serious adverse events comparable to or lower than other highlighted combinations, underscoring its favorable safety profile.
  • In moderately emetic chemotherapy settings, treatments that include both NK1 inhibitors like netupitant or fosnetupitant along with 5-HT3 inhibitors like palonosetron have been found to be more effective at controlling vomiting than those containing only 5-HT3 inhibitors.
  • Akynzeo was also found superior to palonosetron alone while being non-inferior to aprepitant plus granisetron, thus offering significant therapeutic benefits while simplifying antiemetic regimens.
  • The studies did not provide detailed subgroup analyses but suggested that due to its global efficacy and safety profiles, Akynzeo could be beneficial across a broad range of adults undergoing chemotherapy, including those with solid cancers or hematological malignancies.

Product Monograph / Prescribing Information

Document TitleYearSource
Akynzeo (netupitant/fosnetupitant and palonosetron) Prescribing Information2023Helsinn Therapeutics (U.S.), Inc., Iselin, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines