HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LuciTepo safely and effectively. See full prescribing information for LuciTepo.
INDICATIONS AND USAGE
LuciTepo is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations.
DOSAGE AND ADMINISTRATION
• Select patients for treatment with LuciTepo on the presence of METex14 skipping.
• Recommended dosage: 450 mg orally once daily with food until disease progression or unacceptable toxicity.
DOSAGE FORMS AND STRENGTHS
Tablets: 225 mg×60 tablets
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
• Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold LuciTepo in patients with suspected ILD/pneumonitis. Permanently discontinue LuciTepo in patients diagnosed with ILD/pneumonitis of any severity.
• Hepatotoxicity: Monitor liver function tests. Withhold, dose reduce, or permanently discontinue LuciTepo based on severity.
• Pancreatic Toxicity: Monitor amylase and lipase. Withhold, dose reduce, or permanently discontinue LuciTepo based on severity.
• Embryo-fetal toxicity: LuciTepo can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
ADVERSE REACTIONS
Most common adverse reactions (≥ 20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased albumin, decreased sodium, increased gammaglutamyltransferase, increased amylase, increased lipase, increased ALT, increased AST, and decreased hemoglobin.
DRUG INTERACTIONS
• Certain P-gp substrates: Avoid coadministration of LuciTepo with P-gp substrates where minimal concentration changes may lead to serious or lifethreatening toxicities.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed.
Storage
Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.