FOSAPREPITANT- fosaprepitant dimeglumine injection, powder, lyophilized, for solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

SunGen Pharma, LLC

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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  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-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see

Descriptif du produit:

Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized powder for reconstitution. Supplied as follows: NDC 70625-300-01          1 vial per carton. Storage Fosaprepitant for injection vials must be refrigerated, store at 2°C-8°C (36°F-46°F). The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

FOSAPREPITANT- FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
SUNGEN PHARMA, 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):
•
•
Limitations of Use (1)
•
DOSAGE AND ADMINISTRATION
• Recommended Dosage (2.1)
• Administer fosaprepitant as an intravenous infusion; complete the
infusion approximately 30 minutes prior to
che mothe rapy.
• Adults: 150 mg on Day 1.
• Administer Fosaprepitant for injection on Day 1 as an intravenous
infusion over 20 to 30 minutes (adults), completing the
infusion approximately 30 minutes prior to chemotherapy.
• See Full Prescribing Information for dosages of concomitant
antiemetic(s). (2.1) (2)
DOSAGE FORMS AND STRENGTHS
Fosaprepitant for Injection: 150 mg fosaprepitant, lyophilized powder
in single-dose vial for reconstitution. (3)
CONTRAINDICATIONS
•
•
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, 7.2)
•Hypersensitivity Reactions (including anaphylaxis and anaphylactic
shock): May occur during or soon after infusion. If
symptoms occur, discontinue the drug. Do not reinitiate Fosaprepitant
for Injection if symptoms occur with previous use.
(4, 5.2)
•Infusion Site Reactions (including thrombophlebitis, necrosis, and
vasculitis): Majority of reactions report