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Akynzeo for Injection FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved April 19, 2018)
Brand name: Akynzeo for Injection
Generic name: fosnetupitant and palonosetron
Company: Helsinn Healthcare SA
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Akynzeo for Injection (fosnetupitant and palonosetron) is a substance P/neurokinin-1 (NK-1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist combination indicated for use with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of Akynzeo, with or without known hypersensitivity to other 5-HT3 receptor antagonists. Patients should seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur during treatment.
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone, but particularly with concomitant use of serotonergic agents such as medications to treat depression and migraines. If such symptoms occur (changes in mental status, autonomic instability, neuromuscular symptoms, with or without gastrointestinal symptoms), Akynzeo should be discontinued and supportive treatment initiated.

Dosage and Administration

One vial of Akynzeo for injection (reconstituted in 50 ml of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP) administered as 30-minute infusion starting approximately 30 minutes prior to the start of chemotherapy.

Akynzeo Side Effects

The most common side effects of Akynzeo injection include: headache, weakness, fatigue, upset stomach, constipation, and skin redness.

Development timeline for Akynzeo for Injection

Apr 20, 2018Approval FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.