Lorbrena

LORLATINIB

Manufacturer: U.S. Pharmaceuticals

Score: 141.0

Quick Summary

Lorbrena (Lorlatinib) is a kinase inhibitor used for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. The recommended dosage is 100 mg orally once daily, with or without food. Lorbrena has shown efficacy in treating ALK-positive NSCLC, but it also carries important safety information, including warnings for serious hepatotoxicity, central nervous system effects, hyperlipidemia, and other adverse reactions. Dose adjustments are necessary for patients with severe renal impairment, and special considerations are required for use in pregnancy, pediatric, and geriatric populations.

Key Clinical Findings and Indications

Lorbrena is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
The recommended dosage is 100 mg orally once daily, with or without food.
Lorbrena has shown efficacy in treating ALK-positive NSCLC in clinical trials.

Important Safety Information

Warning

Lorbrena is contraindicated in patients taking strong CYP3A inducers due to the potential for serious hepatotoxicity.

Contraindications

Concomitant use with strong CYP3A inducers.

Adverse Reactions

Edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, and cough.
Hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia, increased AST, hypoalbuminemia, increased ALT, increased lipase, and increased alkaline phosphatase.

Dosing Recommendations

General Guidance

Dose reductions are recommended for patients with severe renal impairment or those experiencing adverse reactions.

Metastatic non-small cell lung cancer (NSCLC)

Adult Dose

100 mg orally once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Lorbrena can cause embryo-fetal harm when administered to a pregnant woman.
Advise a pregnant woman of the potential risk to a fetus.

Nursing Mothers

Pediatric Use

The safety and effectiveness of Lorbrena in pediatric patients have not been established.

Geriatric Use

No clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients.

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