Initially 120 mg (three 40-mg tab) once daily. Continue treatment at the prescribed dose for up to 6 mth. May increase dose to 200 mg (five 40-mg tab) once daily in the absence of response after 4 wk of treatment. May reduce daily dose from 120 mg to 80 mg or 200 mg to 120 mg.
Discontinue use in patients who develop posterior reversible encephalopathy syndrome. Interrupt &/or reduce dose in patients w/ QTcF >500 msec. Interrupt treatment if severe signs &/or symptoms of differentiation syndrome persist for >48 hr; other Grade 3 (severe) or greater toxicity related to the drug; 1 wk prior to administration of conditioning regimen for haematopoietic stem cell transplantation. Initiate corticosteroids & hemodynamic monitoring if differentiation syndrome is suspected. Correct hypokalemia or hypomagnesemia prior to & during administration. Evaluate & monitor patients who develop signs & symptoms suggestive of pancreatitis. Assess blood chemistries including creatine phosphokinase prior to treatment initiation on day 15 of cycle 1 & mthly for therapy duration. Perform ECG prior to treatment initiation, on day 8 & 15 of cycle 1 & prior to start of next 2 subsequent cycles. May influence ability to drive & use machines. Severe hepatic impairment (Child-Pugh Class C). Pregnancy testing for females of reproductive potential w/in 7 days prior to treatment initiation. Females & males of reproductive potential should use effective contraception during treatment & for at least 6 mth & at least 4 mth, respectively, after last dose. Pregnancy. Not recommended in lactation during treatment & for at least 2 mth after last dose. Potential risk to fetus. Not recommended for use in childn.
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