Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) in adult patients who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib & for whom subsequent treatment w/ imatinib is not clinically appropriate; or who have the T315I mutation. Philadelphia chromosome +ve acute lymphoblastic leukaemia (Ph+ ALL) in adult patients who are resistant to dasatinib; who are intolerant to dasatinib & for whom subsequent treatment w/ imatinib is not clinically appropriate; or who have the T315I mutation.
Risk of myelosuppression; arterial occlusions; venous thromboembolism; treatment-emergent HTN; formation of aneurysms &/or artery dissections; fatal & serious heart failure or left ventricular dysfunction; pancreatitis; elevation in ALT, AST, bilirubin & alkaline phosphatase; severe haemorrhage; reactivation of hepatitis B. Reports of posterior reversible encephalopathy syndrome (PRES). Perform CBC every 2 wk for the 1st 3 mth & then mthly or as clinically indicated. Assess & monitor CV status prior to & during treatment & manage CV risk factors. Monitor for evidence of thromboembolism. Monitor BP during treatment; HTN should be treated to normal. Check serum lipase every 2 wk for the 1st 2 mth & then periodically thereafter. Perform liver function test prior to treatment initiation & monitor periodically as clinically indicated. Test for HBV infection before initiating treatment. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ moderate & strong CYP3A inhibitors or inducers; anti-clotting agents in patients at risk of bleeding events. Minor influence on the ability to drive & use machines. Patients w/ hepatic impairment; renal impairment (CrCl <50 mL/min) or end-stage renal disease. Use effective contraception during treatment. Should be used during pregnancy only when clearly necessary. Stop breastfeeding during treatment. Elderly. Safety & efficacy in patients <18 yr have not been established.
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