FOSAPREPITANT injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fosaprepitant Dimeglumine (UNII: D35FM8T64X) (Aprepitant - UNII:1NF15YR6UY)

Available from:

NorthStar RxLLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: - acute and delayed nauseaand vomiting associated with initial and repeat coursesof 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 includinganaphylactic reactions, flushing, e

Product summary:

No.120 —Single-dose glass vial containing 150 mg of fosaprepitant as a white to off white lyophilized cake or powder for reconstitution. Supplied as follows:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSAPREPITANT- FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
NORTHSTAR RXLLC
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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 coursesof 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
concomitantantiemetic(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
concomitant drugs. (4, 5.1, 7.1, 7.2)
Hypersensitivity