Treatment of adult patients w/ chronic lymphocytic leukemia (CLL). In combination w/ azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed AML in adults ≥75 yr, or who have comorbidities that preclude use of intensive induction chemotherapy.
CLL Initiate w/ 5-wk ramp-up dosing schedule. Wk 1: 20 mg once daily; wk 2: 50 mg once daily; wk 3: 100 mg once daily; wk 4: 200 mg once daily; wk 5 & beyond: 400 mg once daily. Recommended dose: 400 mg once daily. AML Administer on cycle 1 day 1 following the 3- or 4-day dose ramp-up. Day 1: 100 mg once daily; day 2: 200 mg once daily; day 3: 400 mg once daily; day 4 & beyond: 400 mg once daily of each 28-day cycle in combination w/ azacitidine or decitabine, or 600 mg once daily of each 28-day cycle in combination w/ low-dose cytarabine.
Risk of tumor lysis syndrome (TLS); assess all patients for risk. Pre-medicate w/ anti-hyperuricemics & ensure adequate hydration. Neutropenia. Monitor CBCs throughout treatment period. Risk of infections; monitor patients for signs of infection. Do not administer live attenuated vaccine prior to, during, or after treatment. Patients w/ renal impairment or severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during treatment & for at least 30 days after the last dose. May impair male fertility. Advise women not to breastfeed during treatment & for 1 wk after the last dose. Safety & effectiveness have not been established in ped patients.
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