Approved Use
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 TABRECTA is safe and effective in children.
Important Safety Information
TABRECTA may cause serious side effects. Tell your health care provider right away if you get any of the following:
- Lung or breathing problems. TABRECTA may cause inflammation of the lungs that can cause death. Tell your health care provider right away if you develop any new or worsening symptoms, including:
- cough
- fever
- trouble breathing or shortness of breath
- Liver problems. TABRECTA may cause abnormal liver blood test results. Your health care provider will do blood tests to check your liver function before you start treatment and during treatment with TABRECTA. Tell your health care provider right away if you develop any signs or symptoms of liver problems, including the following:
- your skin or the white part of your eyes turns yellow (jaundice)
- dark or “tea-colored” urine
- light-colored stools (bowel movements)
- confusion
- 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
- Pancreas problems. TABRECTA may cause changes in your blood amylase or lipase levels that may indicate a problem with your pancreas. Your health care provider will do blood tests to check your pancreatic function before you start treatment and during treatment with TABRECTA. Tell your health care 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 eating
- weight loss
- nausea
- vomiting
- Risk of sensitivity to sunlight (photosensitivity). Your skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Use sunscreen or wear clothes that cover your skin during your treatment with TABRECTA to limit direct sunlight exposure
Before you take TABRECTA, tell your health care provider about all 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 health care provider should do a pregnancy test before you start your treatment with TABRECTA
- You should use effective birth control during treatment and for 1 week after your last dose of TABRECTA. Talk to your health care provider about birth control choices that might be right for you during this time
- Tell your health care provider right away if you become pregnant or think you may be pregnant during treatment with TABRECTA
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 of TABRECTA
- 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 of TABRECTA
Tell your health care provider about all the medicines you take or start taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of TABRECTA 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
Your health care provider may change your dose, temporarily stop, or permanently stop treatment with TABRECTA if you develop certain side effects.
These are not all the possible side effects of TABRECTA. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information for TABRECTA, including Patient Information.
