Akynzeo Available in New Dosage Form
April 19, 2018 – The U.S. FDA has approved a new dosage form of Akynzeo® (fosnetupitant/palonosetron), manufactured by Helsinn Healthcare. The drug will now be available for intravenous infusion in single-dose vials of fosnetupitant 235mg/palonosetron 0.25mg. Previously, it was approved only as a fixed-combination oral tablet.
Akynzeo IV is indicated, in combination with dexamethasone, to prevent acute and delayed nausea and vomiting in patients who receive highly emetogenic cancer chemotherapy. Palonosetron is designed to address acute nausea (nausea that occurs within 24 hours of chemotherapy), while fosnetupitant works for up to five days, allowing it to prevent both acute and delayed nausea.
Recommended dosing with Akynzeo IV is one vial distilled in 50mL of IV fluid and infused over the course of 30 minutes prior to chemotherapy administration.
Akynzeo launched in May at a price of $612 per vial.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.