DOCETAXEL injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

docetaxel (UNII: 15H5577CQD) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)

Tilgjengelig fra:

Dr. Reddy's Laboratories Inc.

INN (International Name):

docetaxel

Sammensetning:

DOCETAXEL ANHYDROUS 20 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

One-vial Formulation Docetaxel Injection USP   Docetaxel Injection USP (20 mg/mL) requires NO prior dilution with a diluent and is ready to add to the infusion solution. Docetaxel injection USP is supplied in a single-dose vial as a sterile, pyrogen-free, non-aqueous, solution. Discard unused portion.   Docetaxel injection USP 20 mg/mL (NDC 43598-611-11)  Docetaxel injection USP 20 mg/1 mL: 20 mg docetaxel and 3 mg citric acid anhydrous in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. One single-dose vial in blister in one carton. Docetaxel injection USP 80 mg/4 mL (NDC 43598-610-40)  Docetaxel injection USP 80mg/4 mL: 80 mg docetaxel and 12 mg citric acid anhydrous in 4 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. One single-dose vial in blister in one 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. Docetaxel injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DOCETAXEL- DOCETAXEL INJECTION, SOLUTION
DR. REDDY'S LABORATORIES INC.
----------
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
INJECTION AT 100 MG/M (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 < 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 (5.7, 5.12) 06/2019
Warnings and Precautions (5.8) 12/2019
Warnings and Precautions (5.14) 05/2020
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