Adult patients w/ ROS1 +ve metastatic NSCLC. Adult & ped patients ≥12 yr w/ solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion w/o a known acquired resistance mutation; are metastatic or surgical resection is likely to result in severe morbidity; & have either progressed following treatment or have no satisfactory alternative therapy.
May be taken with or without food: Swallow whole. Do not open, crush, chew, or dissolve the contents of the cap.
Special Precautions
Risk of CHF; QT interval prolongation; vision disorders. Broad spectrum of CNS adverse reactions including cognitive impairment, mood disorders, dizziness & sleep disturbances may occur. Increased risk of fractures; promptly evaluate patients w/ signs or symptoms of fractures. Monitor liver tests including ALT & AST every 2 wk during the 1st mth, then mthly thereafter, & as clinically indicated. Assess serum uric acid levels prior to & periodically during treatment; monitor for signs & symptoms of hyperuricemia. Do not drive or operate hazardous machinery if CNS adverse reactions are experienced. Patients w/ severe renal impairment; moderate & severe hepatic impairment. Advise female patients of reproductive potential to use effective contraception during treatment & for 5 wk following the final dose. Advise male patients w/ female partners of reproductive potential to use effective contraception during treatment & for 3 mth after the final dose. Can cause fetal harm when administered to a pregnant woman. Discontinue breastfeeding during treatment & 7 days after the final dose. ROS1 +ve NSCLC: Ped patients. NTRK gene fusion +ve solid tumors: Ped patients <12 yr.
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