País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FOSAPREPITANT DIMEGLUMINE (UNII: D35FM8T64X) (APREPITANT - UNII:1NF15YR6UY)
Sandoz Inc
INTRAVENOUS
PRESCRIPTION DRUG
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: Limitations of Use 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 contraindicated in patients: Risk Summary There are insufficient data on use of fosaprepitant for injection in pregnant women to inform a drug associated risk. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately equivalent to the exposure at the recommended human dose (RHD) of 150 mg [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unkno
Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized solid for reconstitution. Supplied as follows: Storage Fosaprepitant for injection vials must be refrigerated, store at 2°C to 8°C (36°F to 46°F). The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)].
Abbreviated New Drug Application
FOSAPREPITANT DIMEGLUMINE- FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FOSAPREPITANT FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FOSAPREPITANT FOR INJECTION. FOSAPREPITANT FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2008 INDICATIONS AND USAGE Fosaprepitant for injection is a substance P/neurokinin-1 (NK ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of (1): • • Limitations of Use (1) • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Fosaprepitant for injection: 150 mg fosaprepitant, lyophilized powder in single-dose vial for reconstitution. (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • 1 acute and delayed nausea and vomiting associated with initial and repeat courses of 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). Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting. Recommended Dosage (2.1) Administer fosaprepitant for injection as an intravenous infusion; complete the infusion approximately 30 minutes prior to chemotherapy. Adults: 150 mg on Day 1. Administer fosaprepitant for injection on Day 1 as an intravenous infusion over 20 to 30 minutes (adults). See Full Prescribing Information for dosages of concomitant antiemetic(s). (2.1). Known hypersensitivity to any component of this drug. (4, 5.2) Concurrent use with pimozide. (4) CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor, and inducer of CYP3A4; see Full Prescribing Information for recommendations regarding contraindications, risk of adverse reactions, and dosage adjustmen Leer el documento completo