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What Is Lorlatinib?

Lorlatinib is a prescription kinase inhibitor marketed as Lorbrena. It is indicated for adults with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, confirmed by an FDA-approved test. Current tablets contain 25 mg or 100 mg.

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What Is Lorlatinib?

Lorlatinib is a prescription kinase inhibitor marketed as Lorbrena. It is indicated for adults with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, confirmed by an FDA-approved test. Current tablets contain 25 mg or 100 mg.

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How Does Lorlatinib Work?

Lorlatinib inhibits anaplastic lymphoma kinase and related tyrosine kinases involved in tumor-cell signaling. Blocking abnormal ALK activity can reduce the growth and survival of susceptible cancer cells.

Who Is Treated With Lorlatinib?

Lorlatinib is used in adults with ALK-positive metastatic non-small cell lung cancer, including patients receiving initial targeted treatment. Tumor testing confirms ALK status. Concomitant use with strong CYP3A-inducing medicines is contraindicated due to the risk of serious liver toxicity and reduced drug exposure.

How Is Lorlatinib Dosed?

The recommended dose is 100 mg by mouth once daily, with or without food, until disease progression or unacceptable toxicity. Current labeling recommends 50 mg once daily for severe hepatic impairment and 75 mg once daily for severe renal impairment. Adverse reactions and interacting medicines can require further adjustments.

What Serious Risks Are Linked to Lorlatinib?

Serious risks include changes in cognition, mood, speech, sleep, or mental status, seizures, psychotic symptoms, increased cholesterol and triglycerides, atrioventricular block, interstitial lung disease or pneumonitis, hypertension, high blood glucose, and fetal harm. Lipid levels, electrocardiograms, blood pressure, and glucose are monitored during treatment.

Frequently Asked Questions About Lorlatinib

What cancer does lorlatinib treat?

Lorlatinib treats ALK-positive metastatic non-small cell lung cancer in adults under current U.S. labeling.

What is the usual lorlatinib dose?

The recommended dose is 100 mg by mouth once daily.

Does severe kidney or liver impairment change the dose?

Yes. Current labeling recommends 75 mg daily for severe renal impairment and 50 mg daily for severe hepatic impairment.

Can lorlatinib affect mood or thinking?

Yes. Central nervous system reactions include cognitive and mood changes, speech changes, psychotic symptoms, and seizures.

References

DailyMed - LORBRENA (lorlatinib) tablet, film coated. https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2b34d62d-e02a-4af3-bc0d-1571dd4ee76d. Date Accessed October 13, 2026.

LORBRENA (lorlatinib) Prescribing Information. Pfizer. https://labeling.pfizer.com/ShowLabeling.aspx?id=11140. Date Accessed October 13, 2026.

Lorlatinib. MedlinePlus. https://medlineplus.gov/druginfo/meds/a619005.html. Date Accessed October 13, 2026.

Lorlatinib. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/drugs/lorlatinib. Date Accessed October 13, 2026.

Lorlatinib. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/71731823. Date Accessed October 13, 2026.