Helsinn announced that the Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Akynzeo (fosnetupitant, palonosetron) for use in combination with dexamethasone for the prevention of acute and and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. The IV formulation has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.
Akynzeo (netupitant, palonosetron) was first approved in October 2014 as 300mg/0.5mg strength hard gel capsules. It 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 IV combines fosnetupitant (prodrug of netupitant), a substance P/NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist. Palonosetron prevents nausea and vomiting during the acute phase while fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
Akynzeo for injection will be available as 235mg/0.25mg strength lyophilized powder for reconstitution in single-dose vials; it is preservative-free. It is anticipated to launch in May 2018.
For more information call (844) 357-4668 or visit Akynzeo.com.