FOSAPREPITANT injection, powder, lyophilized, for solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

BE Pharmaceuticals Inc.

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 elevated plasma concentrations of this drug, which is a CYP3A

Produktsammanfattning:

Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized cake or powder for reconstitution. Supplied as follows:  NDC 71839-104-01              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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

FOSAPREPITANT - FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
BE PHARMACEUTICALS INC.
----------
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) 05/2022
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 regimen of
fosaprepitant for injection on Day 1
and aprepitant capsules or aprepitant 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).
• Complete the infusion approximately