DOCETAXEL injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

AuroMedics Pharma LLC

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 a

產品總結:

Docetaxel injection, USP is supplied in single-dose or multiple-dose vials as a sterile, pyrogen-free, non-aqueous clear, colorless to pale yellow solution. Discard unused portion of the single-dose vial. The following strengths are available in a one-vial formulation: 20 mg per 2 mL (10 mg/mL) Single-Dose Vial Packaged Individually                                                                              NDC 55150-378-01 80 mg per 8 mL (10 mg/mL) Multiple-Dose Vial Packaged Individually                                                                              NDC 55150-379-01 160 mg per 16 mL (10 mg/mL) Multiple-Dose Vial Packaged Individually                                                                              NDC 55150-380-01 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 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. The vial stopper is not made with natural rubber latex. Docetaxel injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

授权状态:

Abbreviated New Drug Application

产品特点

DOCETAXEL - DOCETAXEL INJECTION, SOLUTION
AUROMEDICS PHARMA LLC
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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)
AVOID USE OF DOCETAXEL INJECTION 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
(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 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 (5.8, 5.14) 11/2020
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 agent for locally advanced
or metastatic NSCLC after
platinum therapy failure; and with cisplatin for unresectable,