FOSAPREPITANT DIMEGLUMINE injection, powder, lyophilized, for solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Hikma Pharmaceuticals USA Inc.

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 CYP3

Product samenvatting:

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

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FOSAPREPITANT DIMEGLUMINE- FOSAPREPITANT DIMEGLUMINE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
HIKMA PHARMACEUTICALS USA 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
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 Dosage (2.1, 2.2)
Administer fosaprepitant for injection 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 for injection regimen
of fosaprepitant for injection on
Day 1 and aprepitant 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 for injection through a
central venous catheter.
See Full Prescribing Information for dosages of concomitant
antiemetic(s) and pediatric dosages of
fosaprepitant for injection. (2.1, 2.2