DOCETAXEL injection solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Northstar RxLLC

INN (International Adı):

DOCETAXEL ANHYDROUS

Kompozisyon:

DOCETAXEL ANHYDROUS 20 mg in 1 mL

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

DOCETAXEL- DOCETAXEL INJECTION, SOLUTION
NORTHSTAR RXLLC
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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 ×
ULN CONCOMITANT WITH ALKALINE
PHOSPHATASE > 2.5 × 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)
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 ( 5.4)
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)
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 cisplatin for unresectable, locally advanced
or metastatic untreated NSCLC ( 1.2)
HORMONE REFRACTORY PROSTATE CANCER (HRPC): with