120 mg once daily. In the absence of a response [composite complete remission (CRc) is not achieved] after 4 wk of treatment, dose can be increased to 200 mg once daily, if tolerated or clinically warranted.
Associated w/ differentiation syndrome. Initiate corticosteroid therapy w/ hemodynamic monitoring until symptom resolution if differentiation syndrome is suspected. Discontinue use in patients who develop posterior reversible encephalopathy syndrome. Associated w/ prolonged QT interval. Perform ECG prior to treatment initiation, on days 8 & 15 of cycle 1, & prior to the start of the next 3 subsequent mth of treatment. Caution in patients w/ relevant cardiac history. Hypokalaemia or hypomagnesaemia should be corrected prior to & during treatment. Interrupt treatment in patients who have a QTcF >500 msec. Reports of pancreatitis. Avoid concomitant use w/ strong CYP3A4/P-gp inducers; medicinal products that target 5HT2B receptor or sigma nonspecific receptors. Caution in concomitant use w/ strong CYP3A, P-gp &/or breast cancer resistant protein (BCRP) inhibitors. Minor influence on the ability to drive & use machines. Patients w/ severe renal impairment. Not recommended in patients w/ severe (Child-Pugh Class C) hepatic impairment. Advise females of reproductive potential to have a pregnancy test w/in 7 days prior to starting treatment & to use effective contraception during & for at least 6 mth after treatment. Advise males w/ female partners of reproductive potential to use effective contraception during treatment & for at least 4 mth after the last dose. Not recommended during pregnancy & in women of childbearing potential not using effective contraception. Discontinue breast-feeding during treatment & for at least 2 mth after the last dose. Childn <18 yr.
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