HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciGefi is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Limitation of Use: Safety and efficacy of LuciGefi have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

DOSAGE AND ADMINISTRATION

Recommended dose is 250 mg orally, once daily with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 250 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

· Interstitial lung disease (ILD): ILD occurred in patients taking LuciGefi. Withhold LuciGefi for worsening of respiratory symptoms. Discontinue LuciGefi if ILD is confirmed.  

· Hepatotoxicity: Obtain periodic liver function testing. Withhold LuciGefi for Grade 2 or higher for ALT and/or AST elevations. Discontinue for severe hepatic impairment.

· Gastrointestinal perforation: Discontinue LuciGefi for gastrointestinal perforation.  

· Diarrhea: Withhold LuciGefi for Grade 3 or higher diarrhea.

· Ocular Disorders including Keratitis: Withhold LuciGefi for signs and symptoms of severe or worsening ocular disorders including keratitis. Discontinue for persistent ulcerative keratitis.  

· Bullous and Exfoliative Skin Disorders: Withhold LuciGefi for Grade 3 or higher skin reactions or exfoliative conditions.  

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

ADVERSE REACTIONS

The most commonly reported adverse drug reactions (ADRs), reported in more than 20% of the patients and greater than placebo were skin reactions and diarrhea.

DRUG INTERACTIONS

· CYP3A4 Inducer: Increase LuciGefi to 500 mg daily in patients receiving a strong CYP3A4 inducer.

· CYP3A4 Inhibitor: Monitor adverse reactions if concomitant use with LuciGefi.

· Drugs Affecting Gastric pH: Avoid concomitant use of LuciGefi with proton pump inhibitors, if possible.

· Hemorrhage in patients taking warfarin: Monitor changes in prothrombin time or INR.

USE IN SPECIFIC POPULATIONS

Lactation: Discontinue breast-feeding.

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.