Tepotinib drug information compilation

1、 Drug name

1. Common name: Tepotinib

2. Product Name: TEPMETKO ®

2、 Indications

Used to treat adult patients with metastatic non-small cell lung cancer (NSCLC), whose tumors have MET exon 14 skipping mutations. This indication has been granted accelerated approval based on overall response rate and duration of response, and further clinical benefits need to be validated.

3、 Specifications and characteristics

1. Specification: 225mg/tablet

Characteristic: Thin film coated sheet

4、 Main components

1. Active ingredient: Tepotinib hydrochloride hydrate

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

5、 Usage and dosage

1. Recommended dose: 450mg (2 tablets) once daily, taken with food.

2. Usage: Swallow the whole tablet, do not chew, crush or break it open.

3. Omission treatment: If missed, make-up can be taken within 8 hours; Otherwise, skip and take the medication according to the original plan the next day.

4. Vomiting treatment: No need to take additional medication after vomiting, take the next dose according to the planned time.

6、 Dose adjustment

1. Adjust the dosage according to the severity of adverse reactions:

(1) First dose reduction: 225mg (1 tablet) once daily.

(2) Permanent discontinuation of medication: When unable to tolerate a dose of 225mg.

2. Key adjustment situation:

(1) Interstitial lung disease (ILD): If suspected, medication will be temporarily suspended; if diagnosed, medication will be permanently discontinued.

(2) Hepatotoxicity: Pause or reduce according to the degree of ALT/AST elevation.

7、 Medication precautions

1. Dietary requirements: It should be taken together with food to improve absorption.

2. Drug interactions:

Avoid combination use: strong CYP3A inhibitors/P-gp inhibitors (such as ketoconazole), strong CYP3A inducers (such as rifampicin).

3. Use P-gp substrates (such as digoxin) with caution, dosage may need to be adjusted.

8、 Medication for special populations

1. Pregnancy/lactation: with embryo fetal toxicity, contraception should be used until one week after discontinuation of medication; Prohibited during lactation.

2. Liver/kidney dysfunction: Mild to moderate without dose adjustment, severe data insufficient.

3. Elderly: No need to adjust dosage (79% of patients ≥ 65 years old in clinical trials).

9、 Adverse reactions

1. Common (≥ 20%):

Edema, fatigue, nausea, diarrhea, musculoskeletal pain, and difficulty breathing.

2. Serious adverse reactions:

ILD/pneumonia (2.2%, potentially fatal), hepatotoxicity (4.2% ≥ grade 3 ALT/AST elevation).

10、 Contraindications

There are no clear contraindications.

11、 Storage method

Condition: Store in original packaging at 20 ° C-25 ° C (15 ° C-30 ° C allowed).

Tepotinibinformation