DOCETAXEL injection solution concentrate

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Teva Parenteral Medicines, Inc.

INN (Internationale Bezeichnung):

DOCETAXEL ANHYDROUS

Zusammensetzung:

DOCETAXEL ANHYDROUS 20 mg in 1 mL

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DOCETAXEL- DOCETAXEL INJECTION, SOLUTION, CONCENTRATE
TEVA PARENTERAL MEDICINES, INC.
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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._
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INDICATIONS AND USAGE
Docetaxel injection is a microtubule inhibitor indicated for:
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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.
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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)
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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)
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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