The trade name of afatinib, Gilotrif, has been approved for marketing in multiple countries and regions including the United States, China, and the European Union, providing an important targeted treatment option for EGFR mutation positive lung cancer patients.

1、 Drug name

1. Common name: Afatinib

2. Product Name: GILOTRIF ®

2、 Indications

1. The first-line treatment for metastatic non-small cell lung cancer (NSCLC) requires the tumor to carry a non drug resistant EGFR mutation (confirmed by FDA approved testing).

2. Treatment of metastatic squamous NSCLC that progresses after platinum based chemotherapy.

Three specifications and characteristics

1. Tablets: Thin film coated tablets.

4、 Main components

1. Active ingredient: afatinib dicarboxylate.

2. Accessories: lactose, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, etc.

Five Usage and Dosage

1. Conventional dose: 40mg orally, once daily, until disease progression or intolerance occurs.

2. Dosage: Take 1 hour before or 2 hours after meals.

3. Omission treatment: If it is less than 12 hours before the next medication, skip the missed dose.

6、 Dose adjustment

1. Renal insufficiency: severe kidney injury (eGFR15-29mL/min) adjusted to 30mg/day.

2. Adverse reaction adjustment: If there are ≥ grade 3 adverse reactions or specific grade 2 reactions (such as persistent diarrhea, severe skin reactions), the medication should be suspended and reduced by 10mg/day after recovery.

3. Drug interactions:

When P-gp inhibitors (such as ritonavir) are used in combination, the dose is reduced by 10mg/day;

When P-gp inducers (such as rifampicin) are used in combination, the dose is increased by 10mg/day.

7、 Medication precautions

1. Dietary impact: Avoid taking with food, take on an empty stomach for better absorption.

2. Vomiting treatment: If vomiting occurs after taking the medication, there is no need to take it again. Continue with the next dose according to the original plan.

3. Skin care: Common rashes require sun protection and avoidance of irritating skincare products.

8、 Medication for special populations

1. Pregnant women: Prohibited, may cause fetal damage, contraception should be used until 2 weeks after discontinuation.

2. Breastfeeding period: Avoid breastfeeding during discontinuation of medication.

3. Children: Safety has not been established.

4. Elderly: No need to adjust dosage, but close monitoring is required.

9、 Adverse reactions

1. Common (≥ 20%): Diarrhea, rash/acne like dermatitis, stomatitis, paronychia, loss of appetite, nausea, itching.

2. Serious reactions: interstitial lung disease (ILD), hepatotoxicity, gastrointestinal perforation, keratitis, etc.

10、 Contraindications

There are no absolute contraindications, but it is contraindicated for those allergic to active ingredients.

11、 Drug interactions

P-gp inhibitors/inducers significantly affect the blood concentration of afatinib and require dose adjustment (see dose adjustment section).

12、 Storage method

Store at room temperature (20-25 ° C), away from moisture and light.

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