Lorlatinib (Lorviqua) is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that has demonstrated breakthrough efficacy in the treatment of ALK-positive non-small cell lung cancer (NSCLC).

What are the Precautions for Lorlatinib (Lorviqua) Administration?

Dose Adjustment

When co-administered with moderate CYP3A inducers, the dose should be increased to 125 mg once daily.

When co-administered with strong CYP3A inhibitors (e.g., ketoconazole), the initial dose should be reduced to 75 mg once daily.

When co-administered with fluconazole, the dose should be adjusted to 75 mg once daily.

For patients with severe renal impairment (creatinine clearance 15–30 mL/min), the dose should be adjusted to 75 mg once daily.

Pregnancy Management

Lorlatinib has embryo-fetal toxicity. Females of reproductive potential must use effective non-hormonal contraceptive methods, and continue contraception during treatment and for at least 6 months after the last dose.

Male patients must use contraceptive measures during treatment and for 3 months after discontinuation.

Medication Monitoring for Lorlatinib (Lorviqua)

Central Nervous System (CNS) Reaction Monitoring

52% of patients may experience adverse reactions including cognitive function changes (memory decline, confusion), mood swings (depressive tendencies, suicidal ideation), speech disorders, mental status changes, and sleep abnormalities.

Regular neurological assessments are required.

Treatment should be suspended in patients with grade ≥2 reactions; resumption of treatment at a reduced dose is recommended after symptom relief.

Lipid Monitoring

Lipid levels should be tested at baseline, 1–2 months after initiation of treatment, and during regular follow-ups. 83% of patients require initiation of lipid-lowering therapy.

Treatment should be suspended in patients with the first occurrence of grade 4 hypercholesterolemia or hypertriglyceridemia; treatment may be resumed at the original or reduced dose after recovery.

Pulmonary Symptom Monitoring

Vigilance is required for the occurrence of interstitial lung disease (ILD)/pneumonitis (incidence rate: 1.9%). For patients presenting with new or worsening respiratory symptoms such as dyspnea, cough, and fever, immediate imaging examinations are required.

Permanent discontinuation of lorlatinib is mandatory for patients diagnosed with drug-related lung injury.

Blood Pressure Monitoring

Blood pressure should be measured at baseline, 2 weeks after treatment initiation, and monthly thereafter.

Treatment should be suspended in patients with grade 3 hypertension (systolic blood pressure ≥160 mmHg); resumption of treatment at a reduced dose is recommended after blood pressure normalization.