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

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 metastatic castration-resistant prostate cancer. Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced ga

Product summary:

Docetaxel Injection, USP is supplied as a sterile, pyrogen-free, non-aqueous solution in single-dose, flip-top glass vials, as a clear, viscous, colorless to pale yellow solution, without macroscopic particles in solution at 20 mg/mL concentration, in the following package strengths: Docetaxel Injection USP, 20 mg/mL available as one vial per carton                                    NDC 45963-734-54 Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL) available as one vial per carton              NDC 45963-765-52 Discard unused portion. The vial stopper is not made with natural rubber latex. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Retain in the original package to protect from light. Docetaxel Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

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
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._
TREATMENT-RELATED MORTALITY INCREASES WITH ABNORMAL LIVER FUNCTION, AT
HIGHER DOSES,
AND IN PATIENTS WITH NSCLC AND PRIOR PLATINUM-BASED THERAPY RECEIVING
DOCETAXEL
INJECTION AT 100 MG/M (5.1)
AVOID USE OF DOCETAXEL INJECTION 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
(5.2)
DO NOT ADMINISTER DOCETAXEL INJECTION TO PATIENTS WITH NEUTROPHIL
COUNTS <1500
CELLS/MM . OBTAIN FREQUENT BLOOD COUNTS TO MONITOR FOR NEUTROPENIA (4,
5.3)
SEVERE HYPERSENSITIVITY, INCLUDING FATAL ANAPHYLAXIS, HAS BEEN
REPORTED IN PATIENTS
WHO RECEIVED DEXAMETHASONE PREMEDICATION. SEVERE REACTIONS REQUIRE
IMMEDIATE
DISCONTINUATION OF DOCETAXEL INJECTION AND ADMINISTRATION OF
APPROPRIATE THERAPY
(5.5)
CONTRAINDICATED IF HISTORY OF SEVERE HYPERSENSITIVITY REACTIONS TO
DOCETAXEL INJECTION
OR TO DRUGS FORMULATED WITH POLYSORBATE 80 (4)
SEVERE FLUID RETENTION MAY OCCUR DESPITE DEXAMETHASONE (5.6)
INDICATIONS AND USAGE
Docetaxel Injection 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 cisplatin for unresectable, locally
advanced or metastatic untrea