DOCETAXEL- docetaxel anhydrous injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Docetaxel Anhydrous (UNII: 699121PHCA) (Docetaxel Anhydrous - UNII:699121PHCA)

Available from:

Sagent Pharmaceuticals

INN (International Name):

Docetaxel Anhydrous

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:

One-vial Formulation Docetaxel Injection, USP is available as a nonaqueous solution as follows: Docetaxel Injection, USP 20 mg per 1 mL: 20 mg docetaxel in 1 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. The vial is in a blister pack in one carton. Docetaxel Injection, USP 80 mg per 4 mL: 80 mg docetaxel in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. The vial is in a blister pack in one carton. Store between 2° and 25°C (36° and 77°F). Freezing does not adversely affect the product. Protect from light. Retain in carton until time of use. Docetaxel Injection, USP is a hazardous drug. Follow applicable special handling and disposal procedures. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOCETAXEL- DOCETAXEL ANHYDROUS INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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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 AT
100 MG/M (5.1)
AVOID USE OF DOCETAXEL 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 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 AND ADMINISTRATION OF APPROPRIATE THERAPY
(5.5)
CONTRAINDICATED IF HISTORY OF SEVERE HYPERSENSITIVITY REACTIONS TO
DOCETAXEL OR TO
DRUGS FORMULATED WITH POLYSORBATE 80 (4)
SEVERE FLUID RETENTION MAY OCCUR DESPITE DEXAMETHASONE (5.6)
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 untreated
NSCLC (1.2)
CASTRATION-RESISTANT PROSTATE CANCE