Tepotinib
Tepotinib is a targeted cancer medicine used to treat metastatic non-small cell lung cancer driven by a specific genetic change called MET exon 14 skipping.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Tepotinib: Patient Information Guide
A plain-language walkthrough of Tepotinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tepotinib is a targeted cancer medicine approved for use in adults with a specific type of advanced lung cancer.
- Tepmetko (tepotinib tablet, taken by mouth) is approved to treat adults with metastatic non-small cell lung cancer (NSCLC) whose tumors carry a MET exon 14 skipping alteration — a genetic mutation that drives abnormal cancer cell growth. Testing for this mutation (in tumor tissue or, when biopsy is not possible, in blood) is required before treatment.
⚙️How it works▾
Tepotinib targets the MET protein, a receptor on cancer cells that normally controls growth and repair. In some lung cancers, a genetic change called MET exon 14 skipping keeps MET switched on abnormally, signaling cells to multiply and spread uncontrollably. Tepotinib blocks MET and the chain of signals it triggers, slowing tumor growth, limiting cancer cell migration, and reducing metastasis (spread) in preclinical models.
This blockade works whether MET is activated by its natural trigger (a protein called hepatocyte growth factor, or HGF) or by other means — making it effective against multiple mechanisms of MET-driven cancer activity.
💊How it's taken▾
Tepmetko tablets are taken once daily by mouth, always with food, at approximately the same time each day. The tablets should be swallowed whole — not chewed, crushed, or split. If swallowing is difficult, the tablets can be dispersed in plain (non-carbonated) water and drunk immediately.
- If you miss a dose and your next dose is due within 8 hours, skip the missed dose and resume your normal schedule.
- If you vomit after taking a dose, do not take an extra dose — simply take the next one at the scheduled time.
- Treatment continues until the cancer progresses or side effects become unacceptable — your prescriber will guide you.
🤒Side effects — in detail▾
The most common side effects people experience with Tepmetko include:
- Swelling (edema) — very common and the most frequent reason for dose adjustment; can affect legs, face, hands, and other areas
- Nausea
- Fatigue or weakness
- Muscle and joint pain
- Diarrhea
- Shortness of breath
- Decreased appetite
- Rash
- Constipation
- Abdominal pain
- Cough
- Pleural effusion (fluid around the lungs)
Serious reactions requiring immediate attention include signs of lung inflammation (new or worsening shortness of breath, cough, fever), liver problems (yellowing of skin or eyes, dark urine), or pancreatic problems (severe stomach or back pain). Contact your doctor right away if any of these occur.
⚠️Warnings & precautions▾
- Lung inflammation (ILD/pneumonitis): Serious and sometimes fatal lung inflammation has occurred. Watch for new or worsening shortness of breath, cough, or fever. Tepmetko must be stopped immediately if lung inflammation is suspected and permanently discontinued if confirmed.
- Liver toxicity (hepatotoxicity): Elevated liver enzymes and, rarely, liver failure have occurred. Liver function tests are monitored before starting and regularly throughout treatment. Severe cases require dose reduction or permanent discontinuation.
- Pancreatic toxicity: Elevated amylase and lipase (markers of pancreatic stress) have been seen. Pancreatitis requiring permanent discontinuation is possible with severe cases.
- Fetal harm (embryo-fetal toxicity): Tepmetko can cause serious birth defects. It must not be used during pregnancy. Effective contraception is required during treatment and for one week after the last dose — for both women and men.
🔀What it interacts with▾
Tepotinib can affect the levels of certain other drugs in your body. The most important interactions to know about are:
- P-gp substrate drugs (e.g., dabigatran): Tepotinib raises blood levels of drugs that are transported by P-glycoprotein (P-gp). This can increase the risk of serious side effects from those medications. Combining tepotinib with certain P-gp substrates where even small level changes are dangerous should be avoided. If unavoidable, the other drug's dose may need to be reduced.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Tepmetko can cause serious birth defects. Tell your doctor immediately if you are pregnant or think you might be. A pregnancy test is required before starting.
- Breastfeeding: Do not breastfeed during treatment or for one week after the last dose — it is unknown whether tepotinib passes into breast milk.
- Contraception: Both female patients and male patients with female partners of reproductive potential must use effective birth control during treatment and for one week after stopping.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Older adults (65+): Most patients in clinical trials were 65 or older; no significant differences in safety or effectiveness were found compared to younger patients.
- Kidney impairment: No dose adjustment is needed for mild or moderate kidney disease; safety in severe kidney disease has not been fully studied.
- Liver impairment: No dose adjustment is needed for mild or moderate liver disease; safety in severe liver disease has not been studied.
📡Pharmacodynamics — effects in the body▾
At the recommended dose, tepotinib did not cause large increases in the QTc interval (a measure of heart electrical activity) in patients studied, though a concentration-dependent increase was observed. The relationship between tepotinib blood levels and its cancer-fighting effects has not been fully characterized. Tepotinib also interacts with melatonin 2 and imidazoline 1 receptors at levels achieved during treatment, though the clinical significance of this is not established.
🔬Pharmacokinetics — how your body processes it▾
Tepotinib is absorbed after oral dosing, reaching peak blood levels in about 8 hours (range 6–12 hours), and is significantly better absorbed when taken with food — a high-fat meal roughly doubles peak levels compared to fasting. It is very highly protein-bound (98%) and has a half-life of about 32 hours, meaning it takes a day or more for the body to clear half of each dose. Tepotinib is broken down mainly by liver enzymes CYP3A4 and CYP2C8, and the majority of the drug is eliminated through the stool, with a smaller portion leaving via the urine. Drug levels do not vary significantly based on age, sex, race, or mild-to-moderate kidney or liver impairment.
📦How to store it▾
Store TEPMETKO at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) . Store in original package.
📄 Written from Tepotinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Tepotinib
144 supplements and herbal products have documented interactions with Tepotinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 103
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Tepotinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Tepmetko used for? ▾
Do I have to take it with food, and can I crush the tablet? ▾
What side effects are most likely, and what should I watch for? ▾
Are there any medicines I should avoid while taking this? ▾
Can I take Tepmetko if I'm pregnant or planning to become pregnant? ▾
What happens if I miss a dose or vomit after taking it? ▾
Is Tepotinib available over the counter? ▾
When was Tepotinib first available? ▾
💬 Answers drafted from Tepotinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Tepotinib comes
Tepotinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Tepmetko tablets are used to treat adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a MET exon 14 skipping alteration
- Tepmetko tablets are taken once daily by mouth with food
- Swallow Tepmetko tablets whole — do not chew, crush, or split them
- If you cannot swallow tablets, Tepmetko tablets may be dispersed in 30 mL of non-carbonated water, stirred (without crushing) until broken into small pieces, and drunk immediately or within 1 hour; rinse the glass with another 30 mL of water and drink that too
- Tepmetko can also be given through a naso-gastric tube (at least 8 French gauge) using the same water-dispersion method — follow your care team's instructions
📊 Tepotinib across the U.S. market
How Tepotinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Tepotinib products
A representative set of FDA-listed product records for Tepotinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 225 mg | Oral | EMD Serono, Inc. × 3 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Tepotinib NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tepotinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tepotinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Tepotinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2477103 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 2477265In current FDA listingsClinical drug / strength (SCD) 225 MGRxCUI 2477266
Look up RxCUI 2477103 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Tepotinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Tepotinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. EMD Serono, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.