Tepotinib

Tepotinib is used in adults to treat non-small cell lung cancer that has spread to other parts of the body (metastatic).

Your doctor will ensure that you have the right tumor type to be treated with tepotinib.

Tepotinib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your doctor will perform tests to make sure tepotinib is the right treatment for you.

Tepotinib is usually taken once per day with food at the same time each day. You may need to take 2 tablets for your full dose. Follow your doctor's instructions.

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

Read and carefully follow the instructions provided to you on how to use tepotinib to prepare a mixture if you are unable to swallow tablets whole. This mixture may also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

If you vomit shortly after taking tepotinib, do not take another dose. Take your next dose as scheduled.

You will need frequent medical tests, and your dose or medication schedule may be changed based on the results.

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

Store in the original package at room temperature away from moisture and heat.

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

Tell your doctor if you have or have ever had:

• lung or breathing problems other than lung cancer;
• problems with your pancreas; or
• liver disease.

Tepotinib can harm an unborn baby if the mother or the father is using tepotinib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 week after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
• Tell your doctor right away if a pregnancy occurs.

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

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 right away if you have:

• sudden chest pain, wheezing, dry cough, feeling short of breath; or
• signs of liver or pancreas problems—loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed, reduced, or permanently stopped if you have certain side effects.

Common side effects of tepotinib may include:

• shortness of breath;
• nausea, diarrhea, loss of appetite;
• muscle or joint pain;
• skin rash;
• tiredness;
• swelling in your face or any other part of your body; 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.

Usual Adult Dose for Non-Small Cell Lung Cancer:

450 mg orally once a dayDuration of therapy: Until disease progression or unacceptable toxicityUse: For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations

Take the medicine as soon as you can, but skip the missed dose if your next dose is due within 8 hours. Do not take two doses at one time.

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

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

Other drugs may affect tepotinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.