DOCETAXEL injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Sun Pharmaceutical Industries, Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

DOCETAXEL INJECTION is supplied in a single-dose vial for 20 mg/mL, single-dose vial for 80 mg/4 mL and single-dose vial for 160 mg/8 mL as a sterile, pyrogen-free, non-aqueous solution. Discard unused portion. DOCETAXEL INJECTION 20 mg/mL: NDC 47335-323-40 The vial is in a blister pack in one carton. DOCETAXEL INJECTION 80 mg/4 mL: NDC 47335-895-40 The vial is in a blister pack in one carton. DOCETAXEL INJECTION 160 mg/8 mL: NDC 47335-939-40 The vial is in a blister pack in one carton. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Retain in the original package to protect from light. DOCETAXEL INJECTION is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Estat d'Autorització:

New Drug Application

Fitxa tècnica

DOCETAXEL - DOCETAXEL INJECTION, SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, 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/M2 (5.1)
• AVOID USE OF DOCETAXEL INJECTION 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 (5.2)
• DO NOT ADMINISTER DOCETAXEL INJECTION TO PATIENTS WITH NEUTROPHIL
COUNTS <1,500 CELLS/MM3.
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 (5.2, 5.7, 5.8, 5.12) 2/2020
Warnings and Precautions (5.14) 2/2021
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 advanc