FOSAPREPITANT injection, powder, lyophilized, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Novadoz Pharmaceuticals LLC

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.  Fosaprepitant is contraindicated in patients:  -  who are hypersensitive to any component of the product. Hypersensitivity reactions  including  anaphylactic reactions, flus

Přehled produktů:

No. 026 — 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 72205-026-01      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)].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

FOSAPREPITANT - FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
NOVADOZ PHARMACEUTICALS LLC
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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
Warnings and Precautions (5.2) 08/2017
Warnings and Precautions (5.3) 03/2018
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 Dosage (2.1)
Adults: 150 mg on Day 1.
Administer Fosaprepitant for injection on Day 1 as an intravenous
infusion over 20 to 30 minutes (adults), completing
the infusion approximately 30 minutes prior to chemotherapy.
See Full Prescribing Information for dosages of concomitant
antiemetic(s). (2.1)
DOSAGE FORMS AND STRENGTHS
Fosaprepitant for injection: 150 mg fosaprepitant, lyophilized cake or
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
concom