Selective MET kinase inhibitor Pregnancy: Based on findings in animal studies and the mechanism of action, tepotinib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women; oral administration to pregnant rabbits during organogenesis produced malformations and anomalies at maternal exposures below the human exposure at the 450 mg daily clinical dose. Advise pregnant women of the potential risk to a fetus and advise use of effective contraception (§8.1, §5.4).

Tepotinib (Specialist drug)

Brand names: Tepmetko

Tepotinib is an oral MET inhibitor used in the treatment of advanced non-small-cell lung cancer harbouring MET exon 14 skipping alterations. It is a specialist drug initiated under oncology supervision.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 450 mg once daily with food.

Route: Oral. Swallow tablets whole — do not chew, crush or split. Patients who have difficulty swallowing solids may disperse the tablet(s) in 30 mL of non-carbonated water (no other liquid), stir without crushing until dispersed into small pieces, and drink immediately or within 1 hour, then rinse the glass with a further 30 mL and drink it; the dispersion may also be given via a naso-gastric tube of at least 8 French gauge.

Frequency: Once daily, at approximately the same time every day, with food; continue until disease progression or unacceptable toxicity.

Patient selection: for NSCLC patients selected on the presence of MET exon 14 (METex14) skipping alterations in plasma or tumour specimens; plasma testing is recommended only where a tumour biopsy cannot be obtained, and if no alteration is detected in plasma, re-evaluate the feasibility of tissue biopsy. Missed dose: do not make up a missed dose within 8 hours of the next scheduled dose. If vomiting occurs after a dose, take the next dose at the scheduled time. Dose modification: the recommended dose reduction for adverse reactions is 225 mg orally once daily; permanently discontinue in patients unable to tolerate 225 mg once daily. Permanently discontinue for confirmed ILD/pneumonitis of any severity (withhold if suspected), for Grade 4 ALT/AST elevation, for ALT and/or AST above 3 x ULN with total bilirubin above 2 x ULN in the absence of cholestasis or haemolysis, for Grade 4 bilirubin elevation, for Grade 4 lipase/amylase elevation, for Grade 3 or 4 pancreatitis, and for other Grade 4 adverse reactions. Paediatric: safety and efficacy in paediatric patients have not been established (§8.4). Geriatric: no clinically important differences in safety or efficacy in patients 65 years or older (§8.5). Source note: no UK SPC (eMC) record was fetched — regimen taken from the US prescribing information.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None (US label §4)

Side effects

Oedema
Nausea
Fatigue
Musculoskeletal pain
Diarrhoea
Dyspnoea
Decreased appetite
Rash

Interactions

Tepotinib is a P-gp inhibitor and increases the concentration of P-gp substrates — avoid concomitant use with certain P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities; if unavoidable, reduce the P-gp substrate dosage if recommended in its approved labelling (US label §7.1)

Clinical monograph

How it works

It selectively inhibits the MET receptor tyrosine kinase, blocking downstream signalling that drives proliferation and survival of MET-altered tumour cells.

Prescribing in practice

Interstitial lung disease and pneumonitis can occur and may be fatal, so new or worsening respiratory symptoms require prompt evaluation and treatment interruption.
Peripheral oedema is common and may necessitate dose modification, and hepatotoxicity can occur requiring monitoring of liver enzymes.
It requires confirmation of an eligible MET alteration by a validated test before initiation, and interacts with certain P-glycoprotein substrates and CYP3A modulators.

Monitoring

Monitor liver function and assess regularly for fluid retention and respiratory symptoms throughout treatment.

Counselling the patient

Report new cough, breathlessness or fever without delay.
Tell your team about swelling of the legs, ankles or face.
Do not stop or change the dose yourself; attend for your blood tests.

Evidence & guidelines

Tepotinib demonstrated durable responses in MET exon 14 skipping non-small-cell lung cancer in the VISION trial.

Reference: NICE TA789; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways