Precautions of Lorlatinib

Lorlatinib May Cause Severe Adverse Reactions, Including the Following Categories:

Drug Interaction-induced Liver Injury

Before administration, it is imperative to identify the types of drugs that are contraindicated for concurrent use with lorlatinib.

Central Nervous System (CNS) Adverse Reactions

Cognitive impairment (e.g., forgetfulness, confusion), mood changes (e.g., depression, suicidal ideation), psychiatric abnormalities (e.g., hallucinations such as visual or auditory hallucinations), seizures, and alterations in language function or sleep patterns may occur. If new or worsening symptoms of the above CNS adverse reactions appear, immediately inform healthcare professionals.

Elevated Blood Lipid Levels

Most patients experience increased blood cholesterol and triglyceride levels during lorlatinib treatment.

If hyperlipidemia develops during treatment, healthcare professionals may prescribe lipid-lowering medications. For patients already taking such drugs, dosage adjustments may be required.

Healthcare providers should arrange routine blood tests to monitor lipid levels before treatment initiation, 1–2 months after treatment starts, and throughout the entire course of therapy.

Cardiac-related Issues

Severe bradycardia or arrhythmias may occur. Healthcare professionals need to monitor patients’ cardiac rhythm via electrocardiogram (ECG) before treatment and during the treatment period. If symptoms such as dizziness, syncope, or arrhythmia manifest, promptly notify healthcare providers. In some cases, cardiac adverse reactions may be severe, and healthcare professionals may recommend treatment suspension or implantation of a cardiac pacemaker.

Pulmonary-related Issues

Severe, even life-threatening, pulmonary inflammation may develop during treatment. Swelling caused by inflammation can be fatal, with symptoms similar to those of lung cancer. If new or worsening pulmonary symptoms arise—such as dyspnea, shortness of breath, cough, or fever—immediately consult healthcare professionals.

Hypertension

Healthcare providers must monitor blood pressure before treatment initiation, 2 weeks after treatment starts, and at least once monthly during treatment. If hypertension occurs, antihypertensive medications may be prescribed or dosage adjustments made. Should symptoms like headache, dizziness, blurred vision, chest pain, or shortness of breath appear, promptly inform healthcare professionals.

Hyperglycemia

Elevated blood glucose levels may occur in patients. Healthcare professionals should monitor blood glucose via blood tests before and during treatment, and may prescribe or adjust antidiabetic medications as needed to control glucose levels. If new or worsening hyperglycemic symptoms emerge—including extreme thirst, polyuria, unusual hunger, nausea, fatigue, or confusion—immediately notify healthcare providers.

In the event of severe adverse reactions during treatment, healthcare professionals may adjust the dosage, suspend treatment, or permanently discontinue lorlatinib.

FDA,2021.03