The complete official prescribing information should always be consulted before prescribing or dispensing lorlatinib. The summary below is based primarily on the current U.S. LORBRENA label revised in January 2026.
Indication
LORBRENA is indicated for adult patients with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.
Recommended dosage
The recommended U.S. dosage is:
100 mg orally once daily.
Dosage forms
The U.S. product is available as:
- 25 mg tablets
- 100 mg tablets
Contraindication
Concomitant use with strong CYP3A inducers is contraindicated.
Major warnings and precautions
The label addresses:
- Serious hepatotoxicity with strong CYP3A inducers
- Central nervous system effects
- Hyperlipidemia
- Atrioventricular block
- Interstitial lung disease/pneumonitis
- Hypertension
- Hyperglycemia
Drug interactions
Important interaction categories include strong and moderate CYP3A inducers, strong CYP3A inhibitors, fluconazole and certain P-gp substrates.
Special populations
The 2026 U.S. label includes specific recommendations for severe hepatic impairment and renal impairment.
Complete label
This page is only a summary. It does not reproduce the official prescribing information. Healthcare professionals should consult the current regulatory label applicable to their jurisdiction.