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:

Actavis Pharma, 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. 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-

Огляд продуктів:

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.

Статус Авторизація:

New Drug Application

Характеристики продукта

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