Tepmetko

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 Tepmetko is safe and effective in children.

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

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 "What are possible side effects of Tepmetko?" for more information about side effects.

What should I tell my healthcare provider before taking Tepmetko?

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 with Tepmetko.
  • You should use effective birth control (contraception) during treatment and for 1 week after the final dose of Tepmetko. 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 with Tepmetko and for 1 week after the final dose of Tepmetko.
• 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 of Tepmetko.

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

How should I take Tepmetko?

• Take Tepmetko exactly as your healthcare provider tells you to.
• Take Tepmetko 1 time a day with food.
• Swallow Tepmetko tablets. 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 taking Tepmetko unless your healthcare provider tells you to.
• If you miss a dose of Tepmetko, 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 of Tepmetko, take your next dose at your regular scheduled time.

What are the possible side effects of Tepmetko?

Tepmetko may cause serious side effects, including:

• See “What is the most important information I should know about Tepmetko?"
• 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 with Tepmetko. 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 of Tepmetko 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 with Tepmetko if you develop serious side effects during treatment.
These are not all of the possible side effects of Tepmetko. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Tepmetko

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tepmetko for a condition for which it was not prescribed. Do not give Tepmetko to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Tepmetko that is written for health professionals.

How should I store Tepmetko?

• Store Tepmetko at room temperature between 68°F to 77°F (20°C to 25°C).
• Tepmetko tablets come in blister cards with child-resistant blister foil.
• Store Tepmetko in original package.

Keep Tepmetko and all medicines out of the reach of children.

What are the ingredients in Tepmetko?

Active ingredient: tepotinib

Inactive ingredients: mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, and colloidal silicon dioxide.

Tablet coating: hypromellose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin, and red iron oxides.

For more information, call toll-free 1-844-662-3631 or go to www.TEPMETKO.com.