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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

BluePoint Laboratories

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 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

Resumen del producto:

Fosaprepitant for injection:   Single dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized powder for reconstitution. Supplied as follows  NDC 68001-523-36                        1 vial per carton. 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)]. Discard unused portion.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

FOSAPREPITANT- FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
BLUEPOINT LABORATORIES
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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 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 for injection has not been studied for treatment of
established nausea and vomiting.
DOSAGE AND ADMINISTRATION
Recommended Adult Dosage (2.1)
Fosaprepitant for injection 150 mg on Day 1 as an intravenous infusion
over 20 to 30 minutes. ( 2.1)
Complete the infusion approximately 30 minutes prior to chemotherapy.
Recommended Dosage for Pediatric Patients (6 months to 17 years)
Weighing at Least 6 kg (2.2)
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
adjustment of fosaprepitant and
concomitant drugs. ( 4, 5.1, 7.1, 7.2)
•