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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use DOCEFREZ safely and effectively. See full prescribing information for DOCEFREZ.
DOCEFREZ (docetaxel) for Injection
Intravenous Infusion
Initial U.S. Approval: 1996
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WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
See full prescribing information for complete boxed warning
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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/m2 (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)
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Should not be given if neutrophil counts are <1500 cells/mm3. 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 DOCEFREZ and administration of appropriate therapy (5.4)
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Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80(4)
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Severe fluid retention may occur despite dexamethasone (5.5)
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INDICATIONS AND USAGE
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DOCEFREZ is a microtubule inhibitor indicated for:
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Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure (1.1)
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Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure (1.2)
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Hormone Refractory Prostate Cancer (HRPC): with prednisone in androgen independent (hormone refractory) metastatic prostate cancer (1.3)
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DOSAGE AND ADMINISTRATION
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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.
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BC locally advanced or metastatic: 60 mg/m2to 100 mg/m2single agent (2.1)
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NSCLC: after platinum therapy failure: 75 mg/m2single agent (2.2)
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HRPC: 75 mg/m2with 5 mg prednisone twice a day continuously (2.3)
For all patients:
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Premedicate with oral corticosteroids (2.6)
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Adjust dose as needed (2.7)
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DOSAGE FORMS AND STRENGTHS
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Single use vial 80 mg docetaxel and Diluent for 80 mg (3)
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Single use vial 20 mg docetaxel and Diluent for 20 mg (3)
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CONTRAINDICATIONS
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Hypersensitivity to docetaxel or polysorbate 80 (4)
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Neutrophil counts of < 1500 cells/mm3 (4)
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WARNINGS AND PRECAUTIONS
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Acute myeloid leukemia: In patients who received docetaxel, doxorubicin and cyclophosphamide, monitor for delayed myelodysplasia or myeloid leukemia (5.6)
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Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe skin toxicity may require dose adjustment (5.7)
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Neurologic reactions: Reactions including. paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. (5.8)
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Asthenia: Severe asthenia may occur and may require treatment discontinuation. (5.9)
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Pregnancy: Fetal harm can occur when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant when receiving DOCEFREZ (5.10, 8.1)
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ADVERSE REACTIONS
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Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, myalgia (6)
To report SUSPECTED ADVERSE REACTIONS, contact Caraco Pharmaceutical Laboratories, Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch |
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DRUG INTERACTIONS
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| 以下是“全球医药”详细资料 |
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