FOSAPREPITANT injection, powder, lyophilized, for solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Meitheal Pharmaceuticals Inc.

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 for injection is contraindicated in patients: - who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions

Огляд продуктів:

Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized cake or powder 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)]. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

FOSAPREPITANT- FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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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):
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)
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)
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
adjustment of fosaprepitant for
injection and concomitant drugs. (4, 5.1, 7.1