DOCETAXEL ANHYDROUS injection, solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Meitheal Pharmaceuticals Inc

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

Docetaxel Injection, USP is a non-aqueous, clear, colorless to pale yellow solution, and is supplied as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Retain in the original package to protect from light. Freezing does not adversely affect the product. After first use and following multiple needle entries and product withdrawals, Docetaxel Injection, USP multi-dose vials are stable for up to 28 days when stored between 2° and 8°C (36° and 46°F) and protected from light. Docetaxel Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Discard unused portion of the single-dose vial. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

DOCETAXEL ANHYDROUS- DOCETAXEL ANHYDROUS INJECTION, SOLUTION
MEITHEAL PHARMACEUTICALS 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 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 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)
CASTRATI