Afatinib tablets LuciAfa 40mg

Product Name: LuciAfa

Chinese Name: Afatinib Tablets

English Name: Afatinib Tablets

Specification: 40 mg/tablet; 30 tablets/box.

[Indications]

LuciAfa is a kinase inhibitor indicated for:

First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

Limitation of Use: The safety and efficacy of LuciAfa have not been established in patients whose tumors have resistant EGFR mutations.

Treatment of patients with metastatic squamous NSCLC whose disease has progressed after platinum-based chemotherapy.

[Dosage and Administration]

Recommended Dose: 40 mg orally once daily.

Renal Impairment: For patients with severe renal impairment, the recommended dose is 30 mg orally once daily.

Instruct patients to take LuciAfa at least 1 hour before a meal or 2 hours after a meal.

[Contraindications] None.

[Warnings and Precautions]

Diarrhea: Diarrhea may lead to dehydration and renal failure. Withhold LuciAfa for severe and prolonged diarrhea that is unresponsive to anti-diarrheal medications.

Bullous and Exfoliative Skin Disorders: Severe bullous, blistering, and exfoliative lesions occurred in 0.2% of patients. Discontinue the drug for life-threatening skin reactions. Withhold LuciAfa for severe and prolonged skin reactions.

Interstitial Lung Disease (ILD): Occurred in 1.6% of patients. Withhold LuciAfa for acute onset or worsening of pulmonary symptoms. Discontinue LuciAfa if ILD is diagnosed.

Hepatotoxicity: Fatal hepatic injury occurred in 0.2% of patients. Perform periodic liver function testing. Withhold or discontinue LuciAfa for worsening or severe liver disease.

Gastrointestinal Perforation: Occurred in 0.2% of patients. Permanently discontinue LuciAfa in patients who develop gastrointestinal perforation.

Keratitis: Occurred in 0.7% of patients. Withhold LuciAfa for evaluation of keratitis. In cases of confirmed ulcerative keratitis, suspend or discontinue LuciAfa.

Embryo-Fetal Toxicity: May cause fetal harm when administered to pregnant women. Advise pregnant women and women of reproductive potential of the potential risk to the fetus, and recommend the use of effective contraception.

[Adverse Reactions]

The most common adverse reactions (≥20%) are diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, and pruritus.

[Drug Interactions]

P-glycoprotein (P-gp) Inhibitors: Concomitant use with P-gp inhibitors increases afatinib exposure. If not tolerated, reduce the daily dose of LuciAfa by 10 mg.

P-glycoprotein Inducers: Concomitant oral administration of chronic P-gp inducers decreases afatinib exposure. If tolerated, increase the daily dose of LuciAfa by 10 mg.

[Use in Specific Populations]

Lactation: Breastfeeding is not recommended.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.