País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
DOCETAXEL ANHYDROUS (UNII: 699121PHCA) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)
Teva Parenteral Medicines, Inc.
DOCETAXEL ANHYDROUS
DOCETAXEL ANHYDROUS 20 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
DOCETAXEL- DOCETAXEL INJECTION, SOLUTION, CONCENTRATE TEVA PARENTERAL MEDICINES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DOCETAXEL INJECTION ONE-VIAL FORMULATION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOCETAXEL INJECTION ONE-VIAL FORMULATION. DOCETAXEL INJECTION, ONE-VIAL FORMULATION, INTRAVENOUS INFUSION (IV). INITIAL U.S. APPROVAL: 1996 WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, AND FLUID RETENTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • • • INDICATIONS AND USAGE Docetaxel injection is a microtubule inhibitor indicated for: • • • • • DOSAGE AND ADMINISTRATION Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. USE ONLY A 21 GAUGE NEEDLE TO WITHDRAW DOCETAXEL INJECTION FROM THE VIAL. • • • • • • • 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) 2 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) 3 SEVERE HYPERSENSITIVITY, INCLUDING VERY RARE FATAL ANAPHYLAXIS, HAS BEEN REPORTED IN PATIENTS WHO RECEIVED DEXAMETHASONE PREMEDICATION. SEVERE REACTIONS REQUIRE IMMEDIATE DISCONTINUATION OF DOCETAXEL AND ADMINISTRATION OF APPROPRIATE THERAPY (5.4) CONTRAINDICATED IF HISTORY OF SEVERE HYPERSENSITIVITY REACTIONS TO DOCETAXEL OR TO DRUGS FORMULATED WITH POLYSORBATE 80 (4) SEVERE FLUID RETENTION MAY OCCUR DESPITE DEXAMETHASONE (5.5) BREAST CANCER (BC): si Llegiu el document complet