FOCINVEZ- fosaprepitant injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Spes Pharmaceuticals Inc.

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

FOCINVEZ, 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  - FOCINVEZ has not been studied for treatment of established nausea and vomiting. FOCINVEZ 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), and 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 c

Termék összefoglaló:

FOCINVEZ (fosaprepitant injection) contains 150 mg/50 mL (3 mg/mL) of fosaprepitant as a clear and colorless ready-to-use injection solution in a single-dose vial. Supplied as follows:         NDC 82243-1001-1     1 vial per carton. Storage

Engedélyezési státusz:

New Drug Application

Termékjellemzők

FOCINVEZ- FOSAPREPITANT INJECTION
SPES PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOCINVEZ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FOCINVEZ.
FOCINVEZ (FOSAPREPITANT INJECTION) FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
FOCINVEZ 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)
FOCINVEZ has not been studied for treatment of established nausea and
vomiting.
DOSAGE AND ADMINISTRATION
Recommended Adult Dosage ( 2.1)
FOCINVEZ 150mg on Day 1 as an intravenous infusion over 20 to 30
minutes;
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.
_Single dose chemotherapy regimens_: single dose of FOCINVEZ on Day 1.
_Single or multi-day chemotherapy regimens:_3-day regimen of FOCINVEZ
on Day 1 and aprepitant
capsules or aprepitant for oral suspension on Days 2 and 3.
Administer FOCINVEZ through a central venous catheter on Day 1 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
See full prescribing information for additional information. ( 2.1,
2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 150 mg/50 mL (3 mg/mL) of fosaprepitant, in a single-dose
vial. (3)
CONTRAINDICATIONS
Known hypersensitivity to any comp