Xalkori Oral Pellets

Monitor ALT, AST and total bilirubin every 2 weeks during first 2 months, then monthly, and more frequently for elevated transaminases; temporarily suspend, reduce dose, or permanently discontinue as clinically indicated. Monitor CBCs (including differential) weekly for the first month, then at least monthly, and more frequently if Grade 3 or 4 abnormalities, fever or infection occurs. Risk of severe interstitial lung disease (ILD)/pneumonitis: monitor for pulmonary symptoms; permanently discontinue if occurs. Congenital long QT syndrome; avoid. History of or predisposition for QTc prolongation (eg, CHF, bradyarrhythmias, electrolyte abnormalities, or those who are taking drugs known to prolong the QT interval): consider monitoring ECG, electrolytes periodically. Torsade de pointes, ventricular tachycardia, serious arrhythmia: permanently discontinue if QTc >500ms or ≥60ms change from baseline. Monitor HR and BP regularly; discontinue if life-threatening bradycardia occurs. Perform eye assessment monthly in all patients. In ALCL or IMT (peds & young adults): obtain eye exam prior to and within 1 month of initiation (include retinal exam), then every 3 months thereafter; permanently discontinue if Grade 3 or 4 ocular disorders or severe visual loss occurs. Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Use effective contraception during and for at least 45 days (females) or 90 days (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 45 days after the last dose).

Monitor ALT, AST and total bilirubin every 2 weeks during first 2 months, then monthly, and more frequently for elevated transaminases; temporarily suspend, reduce dose, or permanently discontinue as clinically indicated. Monitor CBCs (including differential) weekly for the first month, then at least monthly, and more frequently if Grade 3 or 4 abnormalities, fever or infection occurs. Risk of severe interstitial lung disease (ILD)/pneumonitis: monitor for pulmonary symptoms; permanently discontinue if occurs. Congenital long QT syndrome; avoid. History of or predisposition for QTc prolongation (eg, CHF, bradyarrhythmias, electrolyte abnormalities, or those who are taking drugs known to prolong the QT interval): consider monitoring ECG, electrolytes periodically. Torsade de pointes, ventricular tachycardia, serious arrhythmia: permanently discontinue if QTc >500ms or ≥60ms change from baseline. Monitor HR and BP regularly; discontinue if life-threatening bradycardia occurs. Perform eye assessment monthly in all patients. In ALCL or IMT (peds & young adults): obtain eye exam prior to and within 1 month of initiation (include retinal exam), then every 3 months thereafter; permanently discontinue if Grade 3 or 4 ocular disorders or severe visual loss occurs. Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Use effective contraception during and for at least 45 days (females) or 90 days (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 45 days after the last dose).