FOSAPREPITANT DIMEGLUMINE injection, powder, lyophilized, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Sandoz Inc

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 unkno

Produkt oversigt:

Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized solid 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)].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FOSAPREPITANT DIMEGLUMINE- FOSAPREPITANT DIMEGLUMINE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
SANDOZ 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):
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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: 150 mg fosaprepitant, lyophilized powder
in single-dose vial for reconstitution.
(3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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).
Known hypersensitivity to any component of this drug. (4, 5.2)
Concurrent use with pimozide. (4)
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
adjustmen