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

• has spread to other parts of the body or cannot be removed by surgery (metastatic), and
• whose tumors have an abnormal mesenchymal epithelial transition (MET) gene

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

• Take Tabrecta exactly as your healthcare provider tells you.
• Take Tabrecta tablets 2 times a day with or without food.
• Swallow the tablets whole. Do not break, chew, or crush the tablets.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you have certain side effects.
• Do not change your dose or stop treatment unless your healthcare provider tells you to.
• If you miss or vomit a dose, do not make up the dose. Take your next dose at your regular scheduled time.

Before taking Tabrecta, 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. Tabrecta can harm your unborn baby.
  Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment.
  • You should use effective birth control during treatment and for 1 week after your last dose. Talk to your healthcare provider about birth control choices that might be right for you during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.
  Males who have female partners who can become pregnant:
  • You should use effective birth control during treatment and for 1 week after your last dose.
are breastfeeding or plan to breastfeed. It is not known if Tabrecta passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose.

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

• Your skin may be sensitive to the sun (photosensitivity) during treatment. Use sunscreen or wear clothes that cover your skin during your treatment to limit direct sunlight exposure.

Tabrecta may cause serious side effects, including:

• lung or breathing problems. Tabrecta may cause inflammation of the lungs that can cause death. Tell your healthcare provider right away if you develop any new or worsening symptoms, including:
  • cough
  • fever
  • trouble breathing or shortness of breath
  Your healthcare provider may temporarily stop or permanently stop Tabrecta if you develop lung or breathing problems during treatment.
• liver problems. Tabrecta may cause abnormal liver blood test results. Your healthcare provider will do blood tests to check your liver function before you start, 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 (jaundice)
  • loss of appetite for several days or longer
  • dark or “tea-colored” urine
  • nausea and vomiting
  • light-colored stools (bowel movements)
  • confusion
  • pain, aching, or tenderness on the right side of your stomach-area (abdomen)
  • tiredness
  • weakness
  • swelling in your stomach-area
  Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you develop liver problems.
• risk of sensitivity to sunlight (photosensitivity). See What should I avoid while taking Tabrecta?

The most common side effects include:

• swelling of your hands or feet
• nausea
• tiredness and weakness
• vomiting
• loss of appetite
• changes in certain blood tests

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.