aprepitant

FDA Drug Profile — Aprepitant, EMEND, CINVANTI

Drug Details

Generic Name
aprepitant
Brand Names
Aprepitant, EMEND, CINVANTI
Application Number
ANDA090999
Sponsor
Sandoz Inc
NDC Codes
13
Dosage Forms
CAPSULE, POWDER, FOR SUSPENSION, KIT, INJECTION, EMULSION
Routes
ORAL, INTRAVENOUS
Active Ingredients
APREPITANT

Indications and Usage

1 INDICATIONS AND USAGE Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nauseaand vomiting associated with initial and repeat coursesof highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting. Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Fosaprepitant for injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat coursesof highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use ( 1 ) Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting.