Beizray full Prescribing Information

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

• Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving BEIZRAY at 100 mg/m².
• Avoid use of BEIZRAY 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.
• Do not administer BEIZRAY to patients with neutrophil counts <1500 cells/mm³. Obtain frequent blood counts to monitor for neutropenia.
• Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of BEIZRAY and administration of appropriate therapy.
• Contraindicated if history of severe hypersensitivity reactions to docetaxel.
• Severe fluid retention may occur despite dexamethasone.