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Hyperlipidemia: Serum cholesterol and triglycerides should be monitored before initiation of lorlatinib; 2, 4, and 8 weeks after initiating lorlatinib; and periodically thereafter.
Central nervous system effects: Dose modification or discontinuation may be required for those patients who develop CNS effects.
Atrioventricular block: Dose modification may be required for those patients who develop AV block.
Lipase and amylase increase: Patients should be monitored for lipase and amylase elevations prior to the start of lorlatinib treatment and regularly thereafter as clinically indicated.
Pneumonitis: Any patient who presents with worsening of respiratory symptoms indicative of pneumonitis (e.g., dyspnea, cough, and fever) should be promptly evaluated for pneumonitis. Lorlatinib should be withheld and/or permanently discontinued based on severity.
Hypertension: Blood pressure should be monitored after 2 weeks and at least monthly thereafter during treatment with lorlatinib. Lorlatinib should be withheld and resumed at a reduced dose or permanently discontinued based on severity.
Hyperglycemia: Fasting serum glucose should be assessed prior to initiation of lorlatinib and monitored periodically thereafter. Lorlatinib should be withheld and resumed at a reduced dose or permanently discontinued based on severity.
Risk of serious hepatotoxicity with concomitant use of strong CYP3A inducers: Concomitant use of any strong CYP3A inducer is contraindicated. No clinically meaningful changes in liver function tests were seen in healthy subjects after receiving a combination of lorlatinib with the moderate CYP3A inducer modafinil.
