Safety Information

Lorlatinib requires careful medical supervision because it can affect the central nervous system, lipid metabolism, cardiac conduction, lungs, blood pressure and glucose regulation.

Strong CYP3A inducers

Concomitant use with strong CYP3A inducers is contraindicated because it can substantially reduce lorlatinib exposure and may also produce serious hepatotoxicity. The FDA label recommends discontinuing a strong CYP3A inducer for the specified period before starting LORBRENA.

Central nervous system effects

CNS reactions may include:

Treatment interruption, dose modification or discontinuation may be required depending on severity.

Hyperlipidemia

Lorlatinib commonly increases cholesterol and triglyceride levels. Lipid levels should be assessed and managed according to clinical need.

Atrioventricular block

Lorlatinib can affect cardiac conduction. Patients with relevant cardiac risk factors or symptoms may require appropriate cardiac monitoring.

Interstitial lung disease/pneumonitis

Pulmonary toxicity can occur. New respiratory symptoms should not be assumed to be an ordinary side effect, particularly when symptoms are severe or progressive.

Hypertension

Blood pressure can increase during lorlatinib treatment and should be monitored according to the prescribing information and clinical circumstances.

Hyperglycemia

Lorlatinib may increase blood glucose. Patients with diabetes or other glucose-related risk factors may require additional monitoring.

Drug interactions

Current U.S. labeling identifies important interactions involving:

Pregnancy

The FDA label contains embryo-fetal toxicity information. Pregnancy should be discussed with the treating healthcare professional before treatment.

Lactation

The U.S. prescribing information advises patients not to breastfeed during LORBRENA treatment.

Laboratory monitoring

Depending on the patient’s clinical circumstances, monitoring can include: