Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
FOSAPREPITANT DIMEGLUMINE (UNII: D35FM8T64X) (APREPITANT - UNII:1NF15YR6UY)
Novadoz Pharmaceuticals LLC
INTRAVENOUS
PRESCRIPTION DRUG
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: - 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). 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 is contraindicated in patients: - who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions, flus
No. 026 — Single-dose glass vial containing 150 mg of fosaprepitant as a white to off white lyophilized cake or powder for reconstitution. Supplied as follows: NDC 72205-026-01 1 vial per carton. 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 - FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION NOVADOZ PHARMACEUTICALS 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 RECENT MAJOR CHANGES Warnings and Precautions (5.2) 08/2017 Warnings and Precautions (5.3) 03/2018 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): 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). Limitations of Use (1) Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting. DOSAGE AND ADMINISTRATION Recommended Dosage (2.1) Adults: 150 mg on Day 1. Administer Fosaprepitant for injection on Day 1 as an intravenous infusion over 20 to 30 minutes (adults), completing the infusion approximately 30 minutes prior to chemotherapy. See Full Prescribing Information for dosages of concomitant antiemetic(s). (2.1) DOSAGE FORMS AND STRENGTHS Fosaprepitant for injection: 150 mg fosaprepitant, lyophilized cake or powder in single-dose vial for reconstitution. (3) CONTRAINDICATIONS Known hypersensitivity to any component of this drug. (4, 5.2) Concurrent use with pimozide.(4) WARNINGS AND PRECAUTIONS 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 adjustment of fosaprepitant and concom Đọc toàn bộ tài liệu