FDA Approves Oral Palonosetron for Prevention of Acute Chemotherapy-Induced Nausea and Vomiting

The US Food and Drug Administration (FDA) has approved a new oral formulation of palonosetron hydrochloride (Aloxi) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Oral administration of palonosetron capsules is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5-mg palonosetron capsule is administered approximately 1 hour prior to the start of chemotherapy.

Palonosetron, 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 is administered approximately 30 minutes before the start of chemotherapy.

About CINV

Research has shown that patients with cancer consider CINV among the most dreaded side effects following therapy. Despite prophylactic antiemetics, on the day of chemotherapy, about 30% to 45% of patients experience nausea or vomiting or require rescue therapy following administration of moderately emetogenic chemotherapy. Failure to control acute nausea and vomiting on the first day of chemotherapy will increase the risk of nausea and vomiting on subsequent days and in subsequent cycles of chemotherapy.

Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. No adverse reactions occurred with a frequency greater than or equal to 5% for the 0.5 mg oral dose. The most commonly reported adverse reactions were headache (3.7%) and constipation (0.6%).

Palonosetron prescribing information is available at http://www.aloxi.com/.