The Food and Drug Administration (FDA) has approved a new ready-to-dilute liquid formulation of Akynzeo® injection (fosnetupitant/palonosetron; Helsinn) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, in combination with dexamethasone in adults.
Akynzeo combines fosnetupitant (a 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.
The new liquid formulation, Akynzeo Injection, does not require reconstitution prior to dilution. Moreover, the product does not require refrigeration and may be stored for up to 24 hours at room temperature after dilution.
“This new formulation will reduce the steps in administering this CINV treatment, improving the efficiency in preparation,” said Riccardo Braglia, Helsinn Group Vice Chairman and CEO. “Extended storage time following dilution provides more flexibility to clinics and hospitals to prepare Akynzeo for use throughout the day.”
The Company expects to make the new formulation available in the second half of 2020.
Akynzeo is also available in single-dose vials containing lyophilized powder for reconstitution (Akynzeo for Injection) for the same indication. The capsule formulation is indicated for use 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 have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.
For more information visit helsinn.com.