DOCETAXEL ANHYDROUS injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Cipla USA Inc.

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 metastatic prostate cancer. Docetaxel injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with

Podsumowanie produktu:

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 20°C to 25°C (68°F to 77°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, USP 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 procedures.1  

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DOCETAXEL ANHYDROUS- DOCETAXEL ANHYDROUS INJECTION, SOLUTION
CIPLA USA 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/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 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) 10/2019
Warnings and Precautions (5.7, 5.12) 10/2019
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 with c