Afatinib LuciAfa Afatinib 40mg 30 tablets exported to China 3% customs VAT

Afatinib tablets (LuciAfa) simple instructions

Please use under the guidance of a physician

Product Name: LuciAfa

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Afatinib tablets

English name: Afatinib tablets

Drug approval number: 07 L 1142/24

 

【Indications】

LuciAfa is a kinase inhibitor indicated for:

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

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

•Treatment of patients with metastatic squamous non-small cell lung cancer who have progressed after platinum-based chemotherapy.

 

【Usage and Dosage】

•Recommended dose: 40 mg orally, once daily.

• Renal impairment: Patients with severe renal impairment take 30 mg orally once a day.

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

 

【Specification】

40mg/tablet, 30 tablets/box.

 

【 Contraindications 】

none

 

【 Warnings and precautions 】

• Diarrhea: Diarrhea may lead to dehydration and renal failure. For severe and prolonged diarrhea that does not respond to anti-diarrhea medications, discontinue LuciAfa.

• Bullous and Exfoliative Dermatosis: Severe bullous, blistering, and exfoliative lesions occurred in 0.2% of patients. Discontinue LuciAfa for life-threatening skin reactions. For severe and prolonged skin reactions, discontinue LuciAfa.

• Interstitial lung disease (ILD): Occurred in 1.6% of patients. Discontinue LuciAfa at acute onset or worsening of pulmonary symptoms. If ILD is diagnosed, discontinue LuciAfa.

• Hepatotoxicity: Fatal liver damage occurred in 0.2% of patients. Perform liver examinations regularly. If liver disease worsens or worsens, suspend or discontinue LuciAfa.

• Gastrointestinal perforation: Occurred in 0.2% of patients. LuciAfa should be permanently discontinued in patients who develop gastrointestinal perforation.

• Keratitis: Occurred in 0.7% of patients. Withhold LuciAfa for evaluation of keratitis. For confirmed ulcerative keratitis, withhold or discontinue LuciAfa.

• Embryo-Fetal Toxicity: May cause fetal harm when taken by a pregnant woman. Inform pregnant women and females of reproductive potential of the potential risk to a fetus and to use effective contraception.

 

【Adverse Reactions】

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

 

【Drug Interactions】

• P-glycoprotein (P-gp) inhibitors: Concomitant use of P-gp inhibitors may increase afatinib exposure. If not tolerated, reduce LuciAfa by 10 mg daily.

• P-glycoprotein inducers: Oral co-administration of chronic P-glycoprotein inducers may reduce afatinib exposure. As tolerated, increase the dose by 10 mg LuciAfa daily.

【Use by specific groups】

• Lactation: Breastfeeding is not recommended.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.