Tepotinib is used to treat a certain type of non-small cell lung cancer that has a specific genetic marker (an abnormal "MET" gene). Your doctor will test you for this gene.

Tepotinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to tepotinib, but further studies are needed.

Tepotinib may also be used for purposes not listed in this medication guide.

Tepotinib can cause severe or life-threatening side effects on your lungs. Call your doctor at once if you have a cough, fever, or trouble breathing.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking tepotinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Do not change your dose or stop using this medicine without your doctor's advice.

Store the tablets in the foil blister pack at room temperature, away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

450 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations

Tell your doctor if you have ever had:

• breathing problems before you had lung cancer; or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using tepotinib should use effective birth control to prevent pregnancy. Tepotinib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using tepotinib.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tepotinib may cause serious side effects. Call your doctor at once if you have:

• new or worsening cough or shortness of breath;

• fever; or

• liver problems--loss of appetite, nausea, vomiting, stomach pain or swelling (upper right side), tiredness, confusion, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of tepotinib may include:

• trouble breathing;

• nausea, diarrhea;

• muscle or join pain;

• feeling tired;

• swelling; or

• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect tepotinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to tepotinib. Your doctor will also order a lab test before you begin your treatment to find out if your cancer can be treated with tepotinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.