Adult & ped patients w/ neurotrophic tyrosine receptor kinase (NTRK) fusion +ve locally advanced or metastatic solid tumors, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. ROS1 +ve, locally advanced or metastatic NSCLC.
Adult 600 mg once daily. Dose modifications: 1st dose reduction: 400 mg once daily; 2nd dose reduction: 200 mg once daily. Ped 300 mg/m2 once daily, BSA ≥1.51 m2600 mg once daily; 1.11-1.5 m2 400 mg once daily; 0.81-1.1 m2 300 mg once daily; 0.51-0.8 m2 200 mg once daily; 0.43-0.5 m2 100 mg once daily. Dose modifications: 1st dose reduction w/ starting dose of 600 mg once daily: 400 mg once daily; w/ starting dose of 400 mg once daily: 300 mg once daily; w/ starting dose of 300 mg once daily: 200 mg once daily; w/ starting dose of 200 mg once daily: 200 mg once daily for 5 days each wk; w/ starting dose of 100 mg once daily: 100 mg once daily for 5 days each wk. 2nd dose reduction w/ starting dose of 600 mg once daily: 200 mg once daily; w/ starting dose of 400 mg once daily: 200 mg once daily for 5 days each wk; w/ starting dose of 300 mg once daily: 100 mg once daily; w/ starting dose of 200 mg once daily: 100 mg once daily for 5 days each wk; w/ starting dose of 100 mg once daily: 100 mg once daily for 3 days each wk.
Cognitive disorders including confusion, mental status changes, memory impairment & hallucinations. Cognitive impairment, mood disorders, dizziness & sleep disturbances. Avoid use in patients w/ congenital long QT syndrome & those taking medications that are known to prolong QT interval. Withhold or permanently discontinue treatment based on severity of hepatotoxicity & CNS effects. Withhold treatment for signs & symptoms of hyperuricemia; in patients w/ new visual changes or changes that interfere w/ activities of daily living & conduct ophthalmological evaluation. Assess left ventricular ejection fraction prior to initiation of treatment for patients w/ symptoms or known risk factors of CHF. Monitor patients w/ signs & symptoms of CHF including shortness of breath or edema; cognitive changes; hyperuricemia. Evaluate promptly patients w/ signs or symptoms of fracture. Assess ECG at baseline & monitor ECG & electrolytes periodically; serum uric acid levels prior to initiating therapy & periodically during treatment. Monitor liver tests, including ALT & AST, every 2 wk during 1st mth of treatment, then mthly thereafter. May impair ability to drive & use machines. Severe renal impairment. May cause fetal harm. Women of reproductive potential should have medically supervised pregnancy testing prior to initiating therapy; use highly effective contraceptive methods during treatment & for 5 wk following the last dose. Male patients w/ female partners of childbearing potential must use highly effective contraceptive methods during treatment & for 3 mth following the last dose. Avoid pregnancy during treatment. Discontinue breastfeeding during treatment. Higher incidence of skeletal fractures in ped patients.
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