Tepotinib (tep-OH-ti-nib)

Treats non-small cell lung cancer.

Brand Name(s):

Tepmetko

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk. Take the medicine at the same time each day.
• Swallow the tablet whole. Do not crush, break, or chew it.
• If you are unable to swallow the tablet whole:
  • Place the tablet in a glass with 30 mL of non-carbonated water. Do not use any other liquid.
  • Stir the mixture until the tablet is dispersed into small pieces. Do not crush the tablet.
  • Swallow the mixture right away of within 1 hour of mixing. Do not chew the tablet.
  • Rinse the glass with another 30 mL of non-carbonated water and swallow the mixture until no pieces of tablet are left in the glass.
• You may also give the medicine through a nasogastric tube:
  • Place the tablet in a glass with 30 mL of non-carbonated water. Do not use any other liquid.
  • Give the mixture right away into the feeding tube or within 1 hour.
  • Add 30 mL of non-carbonated water into the same glass and flush through the tube. Repeat this step to make sure that no pieces of tablet are left in the glass or syringe.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, wait until then to use the medicine and skip the missed dose. Do not take extra medicine to make up for the missed dose. If you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular scheduled time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tepotinib works. Tell your doctor if you are using dabigatran.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed while you are using this medicine and for at least 1 week after your last dose.
• Tell your doctor if you have kidney disease, liver disease, other lung or breathing problems, or pancreas problems.
• This medicine may cause the following problems:
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • Liver problems
  • Pancreatitis (swelling of the pancreas)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, cough, fever, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Muscle or bone pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088