US FDA approves Aloxi caps for chemotherapy-induced nausea & vomiting
Eisai Corporation of North America and its partner Helsinn Healthcare SA announced that the US Food and Drug Administration (FDA) has approved a new oral formulation of Aloxi (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV).
Aloxi capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5 mg Aloxi capsule is administered approximately one hour prior to the start of chemotherapy.
Aloxi (palonosetron hydrochloride) injection 0.25 mg, a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, has been available in the United States for intravenous administration since 2003 for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy. A single 0.25 mg intravenous dose of Aloxi is administered approximately 30 minutes before the start of chemotherapy.