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Afatinib, whose trade name is Gilotrif, has been approved for marketing in many countries and regions, including the United States, China, and the European Union, providing an important targeted treatment option for patients with EGFR mutation-positive lung cancer.
1. Generic name: afatinib
2. Trade name: GILOTRIF®
1. First-line treatment of metastatic non-small cell lung cancer (NSCLC). The tumor must carry non-drug-resistant EGFR mutations (confirmed by FDA-approved testing).
2. Treatment of metastatic squamous NSCLC that progresses after platinum-based chemotherapy.
1. Tablets: film-coated tablets.
1. Active ingredient: afatinibdimaleate.
2. Excipients: lactose, microcrystalline cellulose, crospovidone, etc.
1. Conventional dose : 40mg orally, once a day until disease progression or intolerance.
2. Taking : 1 hour before meals or 2 hours after meals.
3. Missed dose handling : If the next dose is less than 12 hours away, skip the missed dose.
1. Renal insufficiency : severe renal impairment (eGFR15-29mL/min) is adjusted to 30mg/day.
2. Adverse reaction adjustment : If ≥ grade 3 adverse reactions or specific grade 2 reactions (such as persistent diarrhea, severe skin reactions) occur, the administration needs to be suspended and the dose reduced by 10 mg/day after recovery.
3. Drug interaction :
When P-gp inhibitors (such as ritonavir) are used in combination, the dose is reduced by 10 mg/day;
When P-gp inducers (such as rifampicin) are used in combination, the dose is increased by 10 mg/day.
1. Influence of diet : Avoid taking it with food. Take it on an empty stomach for better absorption.
2. Vomiting treatment : If you vomit after taking the medicine, there is no need to take a supplement and continue with the next dose as originally planned.
3. Skin care : Common skin rashes require sun protection and avoid irritating skin care products.
1. Pregnant women : It is forbidden, it may cause fetal damage, and contraception is required until 2 weeks after stopping the drug.
2. Lactation : Avoid breastfeeding during the period of drug withdrawal.
3. Children : safety has not been established.
4. U200c for the elderly: No dose adjustment is required, but close monitoring is required.
1. Common (≥20%) : diarrhea, rash/acneoid dermatitis, stomatitis, paronychia, loss of appetite, nausea, and itching.
2. Severe reactions : interstitial lung disease (ILD), liver toxicity, gastrointestinal perforation, keratitis, etc.
There are no absolute contraindications, but it is prohibited for those who are allergic to the active ingredients.
P-gp inhibitors/inducers significantly affect the plasma concentration of afatinib, and the dose needs to be adjusted (see the dose adjustment section).
Save at room temperature (20-25°C), away from moisture and light.