FOSAPREPITANT injection, powder, lyophilized, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

FOSAPREPITANT DIMEGLUMINE (UNII: D35FM8T64X) (APREPITANT - UNII:1NF15YR6UY)

から入手可能:

Mylan Institutional LLC

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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)].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

FOSAPREPITANT- FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MYLAN INSTITUTIONAL LLC
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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):
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Limitations of Use (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Fosaprepitant for Injection: 115 mg and 150 mg fosaprepitant,
lyophilized powder in single-dose vials for reconstitution. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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