DOCETAXEL injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DOCETAXEL ANHYDROUS (UNII: 699121PHCA) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)

Disponible des:

McKesson Packaging Services a business unit of McKesson Corporation

Designació comuna internacional (DCI):

DOCETAXEL ANHYDROUS

Composición:

DOCETAXEL ANHYDROUS 20 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. Docetaxel Injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum based chemotherapy. Docetaxel Injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. Docetaxel Injection in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer. Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of pati

Resumen del producto:

One-vial formulation (Injection) Docetaxel Injection is supplied in single dose and multiple dose vials as a sterile, pyrogen-free, non-aqueous solution. Docetaxel Injection 80 mg/4 mL: The vial is in one carton. NDC 63739-971-17 Docetaxel Injection 20 mg/mL: The vial is in one carton. NDC 63739-932-11 Two-vial formulation (Injection with Diluent) One-vial formulation (Injection) After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light. Follow procedures for proper handling and disposal of anticancer drugs. 1

Estat d'Autorització:

New Drug Application

Fitxa tècnica

DOCETAXEL- DOCETAXEL INJECTION, SOLUTION
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOCETAXEL INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOCETAXEL INJECTION
DOCETAXEL INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
WARNING:TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY
REACTIONS,
AND FLUID RETENTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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INDICATIONS AND USAGE
Docetaxel Injection is a microtubule inhibitor indicated for:
DOSAGE AND ADMINISTRATION
Administer in a facility equipped to manage possible complications
(e.g., anaphylaxis).Administer intravenously over 1 hr
every 3 weeks. PVC equipment is not recommended. FOR ONE-VIAL
FORMULATION, USE ONLY A 21 GAUGE NEEDLE TO
WITHDRAW DOCETAXEL INJECTION FROM THE VIAL.
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TREATMENT-RELATED MORTALITY INCREASES WITH ABNORMAL LIVER FUNCTION, AT
HIGHER DOSES, AND IN PATIENTS
WITH NSCLC AND PRIOR PLATINUM-BASED THERAPY RECEIVING DOCETAXEL AT 100
MG/M ( 5.1)
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SHOULD NOT BE GIVEN IF BILIRUBIN > ULN, OR IF AST AND/OR ALT > 1.5 ×
ULN CONCOMITANT WITH ALKALINE
PHOSPHATASE > 2.5 × ULN. LFT ELEVATIONS INCREASE RISK OF SEVERE OR
LIFE-THREATENING COMPLICATIONS.
OBTAIN LFTS BEFORE EACH TREATMENT CYCLE ( 8.6)
SHOULD NOT BE GIVEN IF NEUTROPHIL COUNTS ARE < 1500 CELLS/MM
. OBTAIN FREQUENT BLOOD COUNTS TO
MONITOR FOR NEUTROPENIA ( 4)
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SEVERE HYPERSENSITIVITY, INCLUDING VERY RARE FATAL ANAPHYLAXIS, HAS
BEEN REPORTED IN PATIENTS WHO
RECEIVED DEXAMETHASONE PREMEDICATION. SEVERE REACTIONS REQUIRE
IMMEDIATE DISCONTINUATION OF
DOCETAXEL INJECTION AND ADMINISTRATION OF APPROPRIATE THERAPY ( 5.4)
CONTRAINDICATED IF HISTORY OF SEVERE HYPERSENSITIVITY REACTIONS TO
DOCETAXEL OR TO DRUGS FORMULATED
WITH POLYSORBATE 80 ( 4)
SEVERE FLUID RETENTION MAY OCCUR DESPITE DEXAMETHASONE ( 5.5)
BREAST CANCER (BC): single agent for locally advanced or me