LuciCapma

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.