FOSAPREPITANT injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MSN LABORATORIES PRIVATE LIMITED

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 summary:

No. 181  — 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 69539-181-01      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)]. Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSAPREPITANT - FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MSN LABORATORIES PRIVATE LIMITED
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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)
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
for injection regimen of
fosaprepitant for injection on Day 1 and aprepitant 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).
Complete the infusion approximately 30 minutes prior to chemotherapy.
Concomitant Antiemetics
S