WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
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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 injection concentrate at 100 mg/m² (5.1)
- Avoid use of docetaxel 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 (5.2)
- Do not administer docetaxel to patients with neutrophil counts < 1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia (4, 5.3)
- Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of docetaxel injection concentrate and administration of appropriate therapy (5.5)
- Contraindicated if history of severe hypersensitivity reactions to docetaxel injection concentrate or to drugs formulated with polysorbate 80 (4)
- Severe fluid retention may occur despite dexamethasone (5.6)