Tepotinib Oral Tablets

What is this medication?

TEPOTINIB (tep OH ti nib) targets proteins in cancer cells and stops the cancer cells from growing. It treats lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TEPMETKO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• liver disease
• lung disease
• an unusual or allergic reaction to tepotinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. Take it with food. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• certain antibiotics like clarithromycin or telithromycin
• certain antivirals for HIV or hepatitis
• certain medicines for cholesterol like atorvastatin, lovastatin, and simvastatin
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a woman pregnant, there is potential for serious harm to an unborn child. You will need to continue wearing a condom for 1 week after stopping the medicine. Tell your health care provider right away if you think your partner might be pregnant.

Do not become pregnant while taking this medicine or for 1 week after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• edema (sudden weight gain; swelling of the ankles, feet, hands or other unusual swelling; trouble breathing)
• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• lack or loss of appetite
• muscle cramps, pain
• nausea
• stomach pain
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original packaging. Talk to your health care provider about how to dispose of unused medicine. Special directions may apply.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.