TEPMETKO Application Scope

TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

TEPMETKO Characteristics

Ingredients: Tepotinib
Properties: A low molecular weight compound and a receptor tyrosine kinase inhibitor
Packaging Specification: 60 film-coated tablets
Storage: Store at room temperature (20°C to 25°C), with excursions permitted between 15°C and 30°C
Expiry Date: 24 months from the date of manufacture
Executive Standard: Approved under the provisions of accelerated approval regulations (21 CFR 314.500)
Approval Number: NDA 214096
Date of Revision: April 25, 2023
Manufacturer: Merck Healthcare KGaA (Germany)

Guidelines for the Use of TEPMETKO

Dosage and Administration:
- Recommended Dose: The recommended dosage is 450 mg of tepotinib (two 225 mg tablets) taken orally once daily with food
- Administration: Tablets should be swallowed whole with water and must not be chewed, crushed, or split
- Missed Dose: If a dose is missed and it is more than 8 hours until the next dose, the missed dose should be taken as soon as possible. If it is less than 8 hours until the next dose, skip the missed dose and take the next dose at the regular time.
Adverse Reactions:
- Common Adverse Reactions: Edema, fatigue, nausea, diarrhea, musculoskeletal pain, decreased appetite, rash, and liver enzyme elevations.
- Serious Adverse Reactions: Interstitial lung disease (ILD), hepatotoxicity, and QT prolongation.
Contraindications: Interstitial lung disease (ILD), hepatotoxicity, and QT prolongation.
Precautions:
- Monitoring: Regular monitoring of liver function tests and assessment for signs of ILD is recommended during treatment.
- Use in Specific Populations: No dosage adjustment is necessary for patients with mild or moderate hepatic impairment; safety and efficacy in patients with severe hepatic impairment have not been established.

TEPMETKO Interactions

Cytochrome P450 Enzymes: Tepotinib is not a substrate, inhibitor, or inducer of CYP enzymes; therefore, CYP-mediated drug interactions are unlikely.
Transporters: Tepotinib is a substrate of P-glycoprotein (P-gp); co-administration with P-gp inhibitors may increase tepotinib plasma concentrations.
Food Effects: Taking TEPMETKO with food increases its bioavailability; therefore, it should be taken with food.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.