For US residents only.
ZYKADIA is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:
It is not known if ZYKADIA is safe and effective in children.
Before you take ZYKADIA, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
ZYKADIA may cause serious side effects, such as:
Stomach and intestinal (gastrointestinal) problems. ZYKADIA causes stomach and intestinal problems in most people, including diarrhea, nausea, vomiting, and stomach-area pain. These problems can sometimes be severe. Follow your health care provider's instructions about taking medicines to help these symptoms. Call your health care provider for advice if your symptoms are severe or do not go away.
Liver problems. ZYKADIA may cause liver injury. Your health care provider should do blood tests at least every month to check your liver while you are taking ZYKADIA. Tell your health care provider right away if you get any of the following:
Lung problems (pneumonitis). ZYKADIA may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your health care provider right away if you have any new or worsening symptoms, including:
Heart problems. ZYKADIA may cause very slow, very fast, or abnormal heartbeats. Your health care provider may check your heart during treatment with ZYKADIA. Tell your health care provider right away if you feel new chest pain or discomfort, dizziness or lightheadedness, if you faint, or have abnormal heartbeats. Tell your health care provider if you start to take or have any changes in heart or blood pressure medicines
High blood sugar (hyperglycemia). People who have diabetes or glucose intolerance or who take a corticosteroid medicine have an increased risk of high blood sugar with ZYKADIA. Your health care provider will check your blood sugar level before starting ZYKADIA and as needed during treatment with ZYKADIA. Call your health care provider right away if you have any symptoms of high blood sugar, including:
Inflammation of the pancreas (pancreatitis). ZYKADIA can cause pancreatitis that has led to death. You may develop increased pancreatic enzyme blood levels, which may be a sign of pancreatitis. Signs and symptoms of pancreatitis include upper abdominal pain that may spread to the back and get worse with eating. Your health care provider should perform blood tests to check your pancreatic enzyme blood levels before you start ZYKADIA and as needed during your treatment
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ZYKADIA. For more information, ask your health care provider or pharmacist.
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.
Keep ZYKADIA and all medicines out of the reach of children.
Active ingredient: ceritinib
Inactive ingredients: colloidal anhydrous silica, L‐hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
Capsule shell contains: gelatin, indigotine, and titanium dioxide