The following information summarizes current U.S. LORBRENA prescribing information. It is not an individualized prescription.
Current U.S. labeled dosage
| Clinical situation | Current U.S. labeled dosage |
|---|---|
| Adult metastatic ALK-positive NSCLC | 100 mg orally once daily |
| Severe hepatic impairment | 50 mg orally once daily |
| Renal impairment requiring adjustment | 75 mg orally once daily |
| Dosage forms | 25 mg and 100 mg tablets |
Administration
LORBRENA is taken orally once daily and may be administered with or without food.
Renal impairment
The January 2026 U.S. label recommends 75 mg once daily for patients with renal impairment requiring the labeled adjustment.
Severe hepatic impairment
For severe hepatic impairment, the revised U.S. label recommends 50 mg once daily. The January 2026 label specifically added this recommendation.
EMA information has also been updated regarding hepatic impairment, including increased lorlatinib exposure in moderate and severe hepatic impairment and a reduced starting dose for severe hepatic impairment.
Dose modifications for adverse reactions
The prescribing information contains specific instructions for withholding, reducing or permanently discontinuing treatment depending on the adverse reaction and its severity.
Relevant toxicities include CNS effects, hyperlipidemia, cardiac conduction abnormalities, pneumonitis, hypertension and hyperglycemia.
Drug-interaction-related dosage changes
Strong CYP3A inducers are contraindicated. The label also provides specific management strategies for moderate CYP3A inducers, strong CYP3A inhibitors, fluconazole and certain P-gp substrates.
Important limitation
The doses above are based on current U.S. labeling. Local product information may differ. Patients should use the prescribing information applicable to their country.