Tepmetko is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that:

• has spread to other parts of the body (metastatic), and
• whose tumors have an abnormal mesenchymal epithelial transition (MET) gene. Your healthcare provider will perform a test to make sure that Tepmetko is right for you.

It is not known if this medicine is safe and effective in children.

 Tepmetko may cause serious side effects, including:

• Lung problems. Tepmetko may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you develop any new or worsening symptoms of lung problems, including:
  • trouble breathing
  • shortness of breath
  • cough
  • fever

See Tepmetko side effects for more information about side effects.

What is Tepmetko?

Tepmetko is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that:

• has spread to other parts of the body (metastatic), and
• whose tumors have an abnormal mesenchymal epithelial transition (MET) gene. Your healthcare provider will perform a test to make sure that Tepmetko is right for you.

It is not known if this medicine is safe and effective in children.

Before you receive Tepmetko

Tell your healthcare provider about all of your medical conditions, including if you:

• have or have had lung or breathing problems other than your lung cancer
• have or have had liver problems
• are pregnant or plan to become pregnant. Tepmetko can harm your unborn baby.
  Females who are able to become pregnant:
  • Your healthcare provider may do a pregnancy test before you start treatment.
  • You should use effective birth control (contraception) during treatment and for 1 week after the final dose. Talk to your healthcare provider about birth control methods that may be right for you.

Males with female partners who are able to become pregnant should use effective birth control during treatment, and for 1 week after the final dose.

• are breastfeeding or plan to breastfeed. It is not known if Tepmetko passes into your breast milk. Do not breastfeed during treatment and for 1 week after the final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Take Tepmetko exactly as your healthcare provider tells you to.
• Take Tepmetko 1 time a day with food.
• Swallow the tablets whole. Do not chew, crush or split tablets.
• Take your dose of Tepmetko at about the same time each day.
• Do not change your dose or stop treatment unless your healthcare provider tells you to.
• If you miss a dose, take it as soon as you remember. If your next dose is due within 8 hours, skip the missed dose and take your next dose at your regular scheduled time.
• If you vomit after taking a dose, take your next dose at your regular scheduled time.

Tell your healthcare provider about all of your medical conditions, including if you:

• have or have had lung or breathing problems other than your lung cancer
• have or have had liver problems
• are pregnant or plan to become pregnant. Tepmetko can harm your unborn baby.
  Females who are able to become pregnant:
  • Your healthcare provider may do a pregnancy test before you start treatment.
  • You should use effective birth control (contraception) during treatment and for 1 week after the final dose. Talk to your healthcare provider about birth control methods that may be right for you.

Males with female partners who are able to become pregnant should use effective birth control during treatment, and for 1 week after the final dose.

• are breastfeeding or plan to breastfeed. It is not known if Tepmetko passes into your breast milk. Do not breastfeed during treatment and for 1 week after the final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tepmetko may cause serious side effects, including:

• See Important information
• Liver problems. Tepmetko may cause abnormal liver blood test results. Your healthcare provider will do blood tests to check your liver function before you start treatment, and during treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
  • your skin or the white part of your eyes turns yellow
  • dark or “tea colored” urine
  • light-colored stools (bowel movements)
  • confusion
  • tiredness
  • loss of appetite for several days or longer
  • nausea and vomiting
  • pain, aching, or tenderness on the right side of your stomach-area (abdomen)
  • weakness
  • swelling in your stomach-area

The most common side effects include:

• swelling in your face or other parts of your body
• tiredness
• nausea
• diarrhea
• muscle and joint pain
• shortness of breath

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you develop serious side effects during treatment.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with 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.