País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DOCETAXEL ANHYDROUS (UNII: 699121PHCA) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)
Alembic Pharmaceuticals Limited
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
Docetaxel Injection, USP is supplied in single-dose or multiple-dose vials as a sterile, pyrogen-free, non-aqueous colorless to pale yellow solution. Discard unused portion of the single-dose vial. The following strengths are available in a one-vial formulation: "Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°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 multiple-dose vials are stable for up to 28 days when stored between 2°C and 8°C (36°F and 46°F) and protected from light. Docetaxel Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .
Abbreviated New Drug Application
DOCETAXEL - DOCETAXEL INJECTION ALEMBIC PHARMACEUTICALS LIMITED ---------- 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 INJECTION IF BILIRUBIN > ULN, OR IF AST AND/OR ALT > 1.5 × ULN CONCOMITANT WITH ALKALINE PHOSPHATASE> 2.5 × 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 PATIENT 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 OR TO DRUGS FORMULATED WITH POLYSORBATE 80 (4) SEVERE FLUID RETENTION MAY OCCUR DESPITE DEXAMETHASONE (5.6) RECENT MAJOR CHANGES Warnings and Precautions (5.8, 5.14) 11/2020 INDICATIONS AND USAGE Docetaxel Injection is a microtubule inhibitor indicated for: (1) 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 unresec Leer el documento completo