País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
FOSAPREPITANT DIMEGLUMINE (UNII: D35FM8T64X) (APREPITANT - UNII:1NF15YR6UY)
Actavis Pharma, Inc.
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. Fosaprepitant for Injection is contraindicated in patients: - who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see Warnings and Precautions (5.2), Adverse Reactions (6.2)] . - taking pimozide. Inhibition of CYP3A4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a CYP3A4 substrate, potentially causing serious or life-
One single-dose glass vial containing 150 mg fosaprepitant as a sterile, white to off-white lyophilized powder for reconstitution. Supplied as follows: NDC 0591-4385-79 1 vial per carton. Storage Store at 2° to 8°C (36° to 46°F). For storage of reconstituted drug solution see Dosage and Administration 2.2.
New Drug Application
FOSAPREPITANT- FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ACTAVIS PHARMA, 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): 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 Dosage (2.1) The recommended dosage in adults is 150 mg on Day 1 as an intravenous infusion over 20 to 30 minutes completing the infusion approximately 30 minutes prior to chemotherapy. See Full Prescribing Information for dosages of concomitant antiemetic(s) of Fosaprepitant for Injection. Preparation (2.2) Reconstitute with 5 mL of 0.9% sodium chloride. Add to infusion bag containing 145 mL 0.9% sodium chloride for a final concentration of 1 mg/mL. DOSAGE FORMS AND STRENGTHS Fosaprepitant for Injection: 150 mg fosaprepitant, lyophilized 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 adjust Leia o documento completo