FOSAPREPITANT injection, powder, lyophilized, for solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Apotex Corp

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults 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 CYP3A4 substrate, potentially causing serious or li

उत्पाद समीक्षा:

Single-dose glass vial containing 150 mg of fosaprepitant as a white lyophilized powder or cake for reconstitution. Supplied as follows: NDC  60505-6105-1 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

FOSAPREPITANT- FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
APOTEX CORP
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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, 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.
Concomitant Antiemetics
See Full Prescribing Information for dosages of concomitant
antiemetic(s). (2.1)
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)
Hypersensitivity Reactions (including anaphylaxis and anaphylactic
shock): May occur during or