البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
FOSAPREPITANT DIMEGLUMINE (UNII: D35FM8T64X) (APREPITANT - UNII:1NF15YR6UY)
Mylan Institutional LLC
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 unkn
Single-dose glass vial containing 115 mg of fosaprepitant as a white to off-white lyophilized powder for reconstitution. Supplied as follows: NDC 67457-888-10 1 vial per carton Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized powder for reconstitution. Supplied as follows: NDC 67457-889-10 1 vial per carton Storage Fosaprepitant for Injection vials must be refrigerated, store at 2° to 8°C (36° 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- FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MYLAN INSTITUTIONAL LLC ---------- 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: 115 mg and 150 mg fosaprepitant, lyophilized powder in single-dose vials for reconstitution. (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS 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) _HEC and MEC (3-Day Dosing Regimen):_ Fosaprepitant for injection (115 mg) is administered on Day 1 as an infusion OVER 15 MINUTES initiated approximately 30 minutes prior to chemotherapy. Aprepitant capsules (80 mg) are given orally on Days 2 and 3. Fosaprepitant for injection and aprepitant capsules are part of a regimen to prevent nausea and vomiting اقرأ الوثيقة كاملة