In combination w/ obinutuzumab or as monotherapy for patients w/ previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). As monotherapy for patients w/ CLL/SLL who have received at least 1 prior therapy. Patients w/ mantle cell lymphoma (MCL) who have received at least 1 prior therapy.
MCL 100 mg bd. CLL/SLL 100 mg bd as monotherapy or in combination w/ obinutuzumab. Separate doses by approx 12 hr. Dose adjustments: Upon resolution of AR to Grade 1 or baseline recovery: Starting dose: 100 mg bd; 1st & 2nd AR occurrence: Restart at 100 mg bd; 3rd AR occurrence: Restart at 100 mg daily. Concomitant use w/ strong CYP3A inducers: Increase dose to 200 mg bd if concomitant use cannot be avoided.
May increase risk of haemorrhage in patients receiving antithrombotics; consider additional monitoring for bleeding signs when concomitant use is medically necessary; consider w/holding treatment for at least 3 days pre- & post-surgery. Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor for signs & symptoms of infection & treat as medically appropriate; CBC (for possible cytopenia including neutropenia & thrombocytopenia); appearance of skin cancers; symptoms (eg, palpitations, dizziness, syncope, chest pain, dyspnoea) of atrial fibrillation & atrial flutter & obtain an ECG as appropriate. Patients w/ severe CV disease. May affect ability to drive or use machines due to potential fatigue & dizziness. Severe renal impairment (eGFR <29 mL/min/1.73 m2) or ESRD. Avoid use in patients w/ severe hepatic impairment (Child-Pugh C or total bilirubin ˃3x ULN & any AST). Women of childbearing potential should avoid becoming pregnant during treatment. Not for use during pregnancy. Do not breastfeed during treatment & for 2 days after receiving the last dose. Childn & adolescents <18 yr.
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