Severe hepatotoxicity occurred in healthy subjects receiving lorlatinib with rifampin, a strong CYP3A inducer; consider discontinuing lorlatinib or CYP3A inducer for persistent Grade ≥2 hepatotoxicity (see Contraindications)
CNS effects (eg, seizures, hallucinations, changes in cognitive function, mood [including suicidal ideation]) may occur Increased serum cholesterol and triglycerides may occur; initiate or increase dose of lipid-lowering agents in patients with hyperlipidemia; monitor serum cholesterol and triglycerides
PR interval prolongation and AV block reported; monitor ECG before initiating treatment and periodically thereafter
Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis can occur