DOCETAXEL injection solution concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCETAXEL (UNII: 15H5577CQD) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)

Available from:

Actavis Pharma, Inc.

INN (International Name):

DOCETAXEL

Composition:

DOCETAXEL ANHYDROUS 20 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

DOCETAXEL- DOCETAXEL INJECTION, SOLUTION, CONCENTRATE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOCETAXEL INJECTION CONCENTRATE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOCETAXEL
INJECTION CONCENTRATE.
DOCETAXEL INJECTION CONCENTRATE, FOR INTRAVENOUS INFUSION (IV)
INITIAL U.S. APPROVAL: 1996
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY
REACTIONS,
AND FLUID RETENTION
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
TREATMENT-RELATED MORTALITY INCREASES WITH ABNORMAL LIVER FUNCTION, AT
HIGHER DOSES, AND IN PATIENTS
WITH NSCLC AND PRIOR PLATINUM-BASED THERAPY RECEIVING DOCETAXEL
INJECTION CONCENTRATE AT 100
MG/M (5.1)
SHOULD NOT BE GIVEN IF BILIRUBIN > ULN, OR IF AST AND/OR ALT > 1.5 X
ULN CONCOMITANT WITH ALKALINE
PHOSPHATASE > 2.5 X 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)
SEVERE HYPERSENSITIVITY, INCLUDING VERY RARE FATAL ANAPHYLAXIS, HAS
BEEN REPORTED IN PATIENTS WHO
RECEIVED DEXAMETHASONE PREMEDICATION. SEVERE REACTIONS REQUIRE
IMMEDIATE DISCONTINUATION OF
DOCETAXEL INJECTION CONCENTRATE AND ADMINISTRATION OF APPROPRIATE
THERAPY (5.4)
CONTRAINDICATED IF HISTORY OF SEVERE HYPERSENSITIVITY REACTIONS TO
DOCETAXEL INJECTION CONCENTRATE OR
TO DRUGS FORMULATED WITH POLYSORBATE 80 (4)
SEVERE FLUID RETENTION MAY OCCUR DESPITE DEXAMETHASONE (5.5)
INDICATIONS AND USAGE
Docetaxel injection concentrate is a microtubule inhibitor indicated
for:
BREAST CANCER (BC): single agent for locally advanced or metastatic BC
after chemotherapy failure; and with
doxorubicin and cyclophosphamide as adjuvant treatment of operable
node-positive BC (1.1)
NON-SMALL CELL LUNG CANCER (NSCLC): single agent for locally advanced
or metastatic NSCLC after platinum
therapy failure; and with cisplat