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

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Camber Pharmaceuticals, Inc.

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 reported  [see Warnings and Precautions ( 5.2), Adverse Reactions ( 6.2)]. • taking pimozide. Inhibition of CYP3A4 by aprepitant, the active moiety, could result in e

Resumo do produto:

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 31722-165-31                        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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FOSAPREPITANT - FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
CAMBER PHARMACEUTICALS, 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
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 5/2022
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)
• See Full Prescribing Information for pediatric dosage regimens by
age.
• For _single dose chemotherapy regimens:_single dose of
fosaprepitant for injection on Day 1.
• For single or multi-day chemotherapy regimens: 3-day fosaprepitant
regimen of fosaprepitant for
injection on Day 1 and fosaprepitant capsules or fosaprepitant for
oral suspension on Days 2 and 3.
• Administer fosaprepitant for injection through a central venous
catheter as an intravenous infusion over
30 minutes (12 years to 17 years) or 60 minutes (6 months to less than
12 years).
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