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Tasigna
nilotinib
Black Box Warnings .
QT Prolongation and Sudden Deaths
prolonged QT and sudden deaths reported; do not use if hypokalemia, hypomagnesemia, or long QT syndrome; avoid drugs that prolong QT interval and strong CYP3A4 inhibitors; avoid food 2h before and 1h after taking dose; correct hypokalemia and hypomagnesemia prior to tx and monitor periodically; obtain ECG to monitor QTc at baseline, then 7 days after tx start, after dose adjustment, and periodically
Adult Dosing .
Dosage forms: CAP: 50 mg, 150 mg, 200 mg
Special Note
- [formulation clarification]
- Info: not interchangeable w/ nilotinib tablets; do not substitute on a mg to mg basis
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
Ph-positive CML
- [chronic phase, newly diagnosed dz]
- Dose: 300 mg PO q12h; Info: give on empty stomach, 1h before or 2h after food; may consider D/C tx if on nilotinib >3y w/ sustained molecular response; cont. monitoring BCR-ABL, CBC w/ diff after D/C q4wk x1y, then q6wk x1y, then q12wk thereafter; restart tx if molecular response lost; see pkg insert for detailed D/C and restart criteria
- [chronic phase, resistant or intolerant dz]
- Dose: 400 mg PO q12h; Info: give on empty stomach, 1h before or 2h after food; may consider D/C tx if on nilotinib >3y w/ sustained molecular response; cont. monitoring BCR-ABL, CBC w/ diff after D/C q4wk x1y, then q6wk x1y, then q12wk thereafter; restart tx if molecular response lost; see pkg insert for detailed D/C and restart criteria
- [accelerated phase, resistant or intolerant dz]
- Dose: 400 mg PO q12h; Info: give on empty stomach, 1h before or 2h after food
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [newly diagnosed Ph-positive CML]
- Child-Pugh Class A, B, or C: start 200 mg q12h
- [resistant or intolerant Ph-positive CML]
- Child-Pugh Class A or B: start 300 mg q12h; Child-Pugh Class C: start 200 mg q12h
Peds Dosing .
- Dosage forms: CAP: 50 mg, 150 mg, 200 mg
Special Note
- [formulation clarification]
- Info: not interchangeable w/ nilotinib tablets; do not substitute on a mg to mg basis
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
Ph-positive CML
- [chronic phase, newly diagnosed dz, 1 yo and older]
- Dose: 230 mg/m^2/dose PO q12h; Max: 400 mg/dose; Info: round dose to nearest 50 mg; give on empty stomach, 1h before or 2h after food; may consider D/C tx if on nilotinib >3y w/ sustained molecular response; cont. monitoring BCR-ABL, CBC w/ diff after D/C q4wk x1y, then q6wk x1y, then q12wk thereafter; restart tx if molecular response lost; see pkg insert for detailed D/C and restart criteria
- [chronic phase, resistant or intolerant dz, 1 yo and older]
- Dose: 230 mg/m^2/dose PO q12h; Max: 400 mg/dose; Info: round dose to nearest 50 mg; give on empty stomach, 1h before or 2h after food; may consider D/C tx if on nilotinib >3y w/ sustained molecular response; cont. monitoring BCR-ABL, CBC w/ diff after D/C q4wk x1y, then q6wk x1y, then q12wk thereafter; restart tx if molecular response lost; see pkg insert for detailed D/C and restart criteria
- [accelerated phase, resistant or intolerant dz, 1 yo and older]
- Dose: 230 mg/m^2/dose PO q12h; Max: 400 mg/dose; Info: round dose to nearest 50 mg; give on empty stomach, 1h before or 2h after food
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance