DOCETAXEL injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Armas Pharmaceuticals Inc.

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 Docetaxel Injection, USP Docetaxel injection, USP is supplied in a single use vial as a sterile, pyrogen-free, non-aqueous solution. Discard unused portion. Docetaxel injection, USP 80 mg/4 mL (4 mL fill): NDC 72485-215-04, single-use vial individually packaged in a carton. Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published [see References (15) ].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOCETAXEL- DOCETAXEL INJECTION
ARMAS PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOCETAXEL INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOCETAXEL INJECTION,
USP.
DOCETAXEL INJECTION, USP 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)
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, 5.3)
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 (5.5)
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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.4, 5.5) 10/2018
Warnings and Precautions (5.7, 5.12) 06/2019
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 wi