Tepotinib(Tepmetko)

Tepotinib is a prescription drug targeting mesenchymal‑epithelial transition factor (MET). It was first approved in Japan in March 2020, granted accelerated approval by the US FDA in February 2021, and converted to regular approval in February 2024. Its use must be strictly in accordance with medical advice.

Target of Action

Mesenchymal-Epithelial Transition factor (MET).

Dosage and Administration

Route and frequency of administration of Tepotinib: oral, once daily.

The dosage of Tepotinib should be adjusted according to the patient's actual condition; specific circumstances require consultation with a physician and adherence to medical advice.

Recommended reading: Dosage and Administration of Tepotinib

Side Effects

Common side effects: edema, nausea, fatigue, etc.

Serious side effects: interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, pancreatic toxicity, etc.

Reference article: Side Effects of Tepotinib

Use in Special Populations

Pregnancy: Based on animal study results and its mechanism of action, Tepotinib may cause fetal harm when administered to pregnant women. Pregnant women should be informed of the potential risk to the fetus. Women of childbearing potential or male patients whose partners are of childbearing potential should be advised to use effective contraception during treatment with Tepotinib and for one week after the last dose.

Lactation: It is unknown whether Tepotinib passes into breast milk. Do not breastfeed during treatment and for one week after the last dose of Tepotinib.

Daily Precautions

1. Inform patients that if a dose of Tepotinib is missed, it can be taken as soon as remembered on the same day, but if it is less than 8 hours until the next scheduled dose, the missed dose should be skipped. If vomiting occurs after taking Tepotinib, instruct patients to take the next dose at the scheduled time without an additional dose.

2. Inform patients with difficulty swallowing solids that Tepotinib tablets can be dispersed in water for administration to ensure the full dose is taken.

3. Inform patients of the risk of serious or fatal interstitial lung disease/pneumonitis. Instruct patients to contact their healthcare provider immediately and report if new or worsening respiratory symptoms occur.

from FDA，2023.03