FOSAPREPITANT injection, powder, lyophilized, for solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Praxgen Pharmaceuticals LLC

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older 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 has not been studied for the treatment of established nausea and vomiting. 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 con

Resumen del producto:

Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized powder for reconstitution. Supplied as follows: NDC 70625-311-01          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)].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FOSAPREPITANT- FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
PRAXGEN PHARMACEUTICALS LLC
----------
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 (NK1)
receptor antagonist, indicated in adults and
pediatric patients 6 months of age and older, 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 has not been studied for treatment of established nausea
and vomiting.
DOSAGE AND ADMINISTRATION
Recommended Dosage ( 2.1, 2.2)
Administer fosaprepitant as an intravenous infusion; complete the
infusion approximately 30 minutes
prior to chemotherapy.
Adults: 150 mg on Day 1.
_Pediatrics (6 months to 17 years): _a single-day of Fosaprepitant for
injection on Day 1 (for single dose
chemotherapy regimens) or a 3- day fosaprepitant regimen of
fosaprepitant for injection on Day 1 and
fosaprepitant capsules or oral suspension on Days 2 and 3 (for single
or multi-day chemotherapy
regimens).
Administer fosaprepitant for injection on Day 1 as an intravenous
infusion over 20 to 30 minutes
(adults), 30 minutes (12 years to 17 years) or 60 minutes (6 months to
less than 12 years).
In pediatrics, administer fosaprepitant through a central venous
catheter.
See Full Prescribing Information for dosages of concomitant
antiemetic(s) and pediatric dosages of
fosaprepitant. ( 2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Fosaprepitant for injection: 150 mg fosaprepitant, lyophil