Complete dosing information for OBECABTAGENE AUTOLEUCEL
Medical guidance required: Dosing information here is for educational purposes. Your healthcare provider will determine the appropriate dose based on your specific condition, kidney function, other medications, and medical history. Never adjust your dose without consulting your doctor or pharmacist.
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter ( 2.4 ). Prior to infusion Administer a lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide. ( 2.3 ). Ensure availability of bone marrow assessment results from a sample obtained within 7 days prior to start of lymphodepleting chemotherapy ( 2.3 ). Premedicate with acetaminophen ( 2.3 ). Confirm availability of tocilizumab prior to infusion ( 2.3 ). AUCATZYL Dose and Administration Verify patient's identity prior to infusion ( 2.3 ). Dosing is based on the Dose Schedule Planner ( 2.3 ). The total recommended dose of AUCATZYL is 410 × 10 6 CD19 chimeric antigen receptor (CAR)-positive viable T cells ( 2.1 ). The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10 (± 2 days) ( 2.1 ). Dose to be administered is determined by the patient bone marrow blast assessment. See Full Prescribing Information for important preparati