Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DOCETAXEL (UNII: 15H5577CQD) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)
Armas Pharmaceuticals Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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
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 160 mg/8 mL (8 mL fill): NDC 72485-216-08, 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) ].
Abbreviated New Drug Application
DOCETAXEL- DOCETAXEL INJECTION ARMAS PHARMACEUTICALS INC. ---------- 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 Lire le document complet