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Tepotinib is an oral kinase inhibitor that mainly acts on MET receptor tyrosine kinase.
1. Generic name: Tepotinib
2. Trade name: TEPMETKO®
It is used to treat adult patients with metastatic non-small cell lung cancer (NSCLC) and whose tumors have MET exon 14 skipping mutations.
1. Specifications: 225 mg per tablet (based on tepotinib).
2. Characteristics: Film-coated tablets.
1. Active ingredient: Tepotinib hydrochloride hydrate (equivalent to 225mg Tepotinib).
2. Excipients: Mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silica, etc.
3. Coating ingredients: Hypromellose, titanium dioxide, lactose, polyethylene glycol, triacetin, iron oxide red, etc.
1. Recommended dose: 450mg (2 tablets) once a day, taken with food.
2. How to take: Swallow the tablet whole. Do not chew, crush or break it.
3. Course of treatment: Continue medication until disease progression or intolerable toxicity occurs.
1. First dose reduction: 225 mg (1 tablet) once a day.
2. Permanent discontinuation: If you cannot tolerate 225 mg once a day.
3. Specific adjustment basis:
(1), ILD/pneumonia: if suspected, the drug will be suspended; if confirmed, the drug will be permanently discontinued.
(2) Hepatotoxicity: Suspend or discontinue the drug according to the degree of increase in ALT/AST/total bilirubin.
4. Other adverse reactions: Adjust the dose or discontinue the drug according to the severity (grade 2–4).
1. Take after meals: Improve bioavailability.
2. Missed dose: If it is more than 8 hours before the next dose, you can take it again, otherwise skip it.
3. Vomiting: There is no need to take another dose after vomiting. Take the next dose according to the original plan.
1. Pregnant women: There is a risk of fetal teratogenesis and effective contraception is required.
2. Breastfeeding: Breastfeeding is not recommended during treatment and within 1 week after the last dose.
3. The elderly: No dose adjustment is required
4. Liver/renal insufficiency: No adjustment is required for mild to moderate, and there is insufficient data for severe cases.
1. Common (≥20%):
Edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.
2. Serious adverse reactions:
(1), ILD/pneumonia (2.2%, can be fatal).
(2), liver toxicity (13% ALT/AST increased, 0.2% died of liver failure).
(3) Laboratory abnormalities: lymphopenia, hypoalbuminemia, hyponatremia, elevated GGT/ALT/AST, etc.
No clear contraindications.
1. Avoid combination with:
Strong CYP3A inhibitors or inducers.
2. P-gp inhibitors
P-gp substrates with narrow therapeutic windows (such as digoxin, dabigatran).
Monitoring required: The dosage of the latter may need to be adjusted when used in combination with P-gp substrates.
1. Store in original packaging, away from light and moisture.
2. Temperature: 20°C–25°C (15°C–30°C allowed).
3. Keep out of reach of children.