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tepotinib

Pronunciation: tep OH ti nib

Brand: Tepmetko

What is the most important information I should know about tepotinib?

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.

What is tepotinib?

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 this medicine, but further studies are needed.

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

What should I discuss with my healthcare provider before taking tepotinib?

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 this medicine 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.

How should I take tepotinib?

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.

What happens if I miss a 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.

What happens if I overdose?

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

What should I avoid while taking tepotinib?

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

What are the possible side effects of tepotinib?

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

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 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.

What other drugs will affect tepotinib?

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.

Where can I get more information?

Your pharmacist can provide more information about tepotinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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