Tepotinib

Tepotinib is used to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Tepotinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Tepotinib comes as a tablet to take by mouth. It is usually taken once daily with food. Take tepotinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tepotinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you cannot swallow the tablets whole, place the tablets in a glass of 1 ounce (30 mL) of non-carbonated water. Do not use any other liquids other than water. Stir until the tablets are in small pieces. Do not crush the tablets; they will not completely dissolve. Drink the mixture right away or within 1 hour of preparing. Do not chew pieces of the tablet. Rinse the glass with an additional 1 ounce (30 mL) of water and drink to make sure that you have taken the full dose.

If you have a nasogastric (NG) tube, your doctor or pharmacist will explain how to give tepotinib through a NG tube.

If you vomit after taking tepotinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose or temporarily or permanently stop your treatment depending on if you experience any side effects. Be sure to tell your doctor how you are feeling during your treatment with tepotinib.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tepotinib,

• tell your doctor and pharmacist if you are allergic to tepotinib, any other medications, or any of the ingredients in tepotinib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had lung or breathing problems other than lung cancer, pancreatitis (swelling of the pancreas), or kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking tepotinib. You will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your treatment and for at least 1 week after your final dose. If you are a male with a female partner who may become pregnant, you should use birth control to prevent pregnancy during you treatment and for at least 1 week after your final dose. Talk to your doctor about birth control methods that will work for you. Tepotinib may harm your unborn baby. If you or your partner become pregnant during your treatment with tepotinib, call your doctor immediately.
• tell your doctor if you are breast-feeding. You should not breast-feed while you are taking tepotinib and for at least 1 week after your final dose.

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

Take the missed dose as soon as you remember it. However, if it is within 8 hours of your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tepotinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling of the arms, hands, feet, or lower legs
• nausea
• diarrhea
• constipation
• vomiting
• loss of appetite
• abdominal pain
• tiredness
• muscle, joint, or bone pain
• rash or itching
• dizziness
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• shortness of breath, trouble breathing, fever, or cough
• pain in right upper part of the stomach, swelling in your stomach area, unusual bruising or bleeding, dark urine, light colored stools, yellowing of the skin and eyes, or weakness
• confusion
• ongoing pain that begins in the stomach area, but may spread to the back; nausea; vomiting; weight loss

Tepotinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

• Tepmetko^®