HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciCapma safely and effectively. See full prescribing information for LuciCapma.

INDICATIONS AND USAGE

LuciCapma is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

DOSAGE AND ADMINISTRATION

• Select patients for treatment with LuciCapma based on presence of a mutation that leads to MET exon 14 skipping.

• Recommended Dosage: 400 mg orally twice daily with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 200 mg×60 tablets

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Permanently discontinue LuciCapma in patients with ILD/pneumonitis.  

• Hepatotoxicity: Monitor liver function tests. Withhold, dose reduce, or permanently discontinue LuciCapma based on severity.

• Pancreatic Toxicity: Monitor amylase and lipase levels. Withhold, dose reduce, or permanently discontinue LuciCapma based on severity.

• Hypersensitivity Reactions: Withhold or permanently discontinue LuciCapma based on severity.

• Risk of Photosensitivity: May cause photosensitivity reactions. Advise patients to limit direct ultraviolet exposure.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥ 20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.

DRUG INTERACTIONS

Strong and Moderate CYP3A Inducers: Avoid concomitant use.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

Storage

Dispense in the original package with the desiccant cartridge. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Discard any unused LuciCapma remaining after 6 weeks of first opening the bottle.