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DOCETAXELinjection, solution

2014-01-16 00:21:00 来源: 作者: 【大中小】浏览:367次评论:0条

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, Solution for Intravenous Infusion
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/m2 (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/mm3. 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 prednisone in androgen independent (hormone refractory) metastatic prostate cancer (1.3)

Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)

Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)

DOSAGE AND ADMINISTRATION

Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously over 1 hr every 3 weeks. PVC equipment is not recommended.

BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent (2.1)
BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (2.1)
NSCLC: after platinum therapy failure: 75 mg/m2 single agent (2.2)
NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2 (2.2)
HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously (2.3)
GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr intravenous infusion (days 1–5), starting at end of cisplatin infusion (2.4)
SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 intravenously (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr intravenous infusion (days 1–5), starting at end of cisplatin infusion; for 4 cycles (2.5)
SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 intravenously (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr intravenous infusion (days 1–4); for 3 cycles (2.5)