Tabrecta

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.

• 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.

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
• have or have had pancreatic 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.

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

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.
• allergic reactions. Tabrecta can cause an allergic reaction. Stop taking Tabrecta and tell your healthcare provider right away if you get any signs and symptoms of an allergic reaction, including:feverchillsitchingrashdizziness or feeling faintnauseavomiting
• pancreas problems. Tabrecta may cause increases in your blood amylase and/or lipase levels that may indicate a problem with your pancreas. Your healthcare provider will do blood tests to check your pancreatic function before you start treatment and during treatment. Tell your healthcare provider right away if you develop any signs and symptoms of pancreas problems, including:upper stomach (abdominal) pain that may spread to your back and get worse with eatingweight lossnauseavomiting
• 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
• muscle or bone pain
• tiredness and weakness
• vomiting
• trouble breathing
• cough
• 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.

• Store Tabrecta at room temperature between 68°F to 77°F (20°C to 25°C).
• Store tablets in the original package with the drying agent (desiccant) cartridge.
• Protect the tablets from moisture.
• Throw away (discard) any unused Tabrecta you have left after 6 weeks of first opening the bottle.

Keepall medicines out of the reach of children and pets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.

Active ingredient: capmatinib Inactive ingredients: Tablet core: colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate. Tablet coating (150 mg): ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. Tablet coating (200 mg): ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide.