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Understanding Side Effects

ZYKADIA® (ceritinib)

Treatment for anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) means staying on therapy as long as it continues to work or until you develop side effects that do not allow you to continue. When taking ZYKADIA® (ceritinib), there is the potential for side effects to occur. That's why it's important to understand how best to manage them. Some side effects would require ZYKADIA to be discontinued.

Talk to your health care provider about your side effects

What are the possible side effects of ZYKADIA?

ZYKADIA may cause serious side effects, including:

Stomach and intestinal (gastrointestinal) problems. ZYKADIA may cause stomach and intestinal problems, including diarrhea, nausea, vomiting, and stomach-area pain. Follow your health care provider's instructions about taking medicines to help with these symptoms. Call your health care provider for advice if your symptoms are severe or cannot be tolerated.

Liver problems. ZYKADIA may cause liver injury. Your health care provider should do blood tests at least every month to check your liver during treatment with ZYKADIA. Tell your health care provider right away if you get any of the following:

  • you feel tired
  • you have itchy skin
  • your skin or the whites of your eyes turn yellow
  • you have nausea or vomiting
  • you have a decreased appetite
  • you have pain on the right side of your stomach-area
  • your urine turns dark or brown (tea color)
  • you bleed or bruise more easily than normal

Lung problems (pneumonitis). ZYKADIA may cause severe or life-threatening swelling (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:

  • trouble breathing or shortness of breath
  • cough with or without mucus
  • fever
  • chest pain

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:

  • increased thirst
  • increased hunger
  • headaches
  • trouble thinking or concentrating
  • urinating often
  • blurred vision
  • tiredness
  • your breath smells like fruit

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 do blood tests to check your pancreatic enzyme blood levels before you start ZYKADIA and as needed during your treatment.

The most common side effects of ZYKADIA include:

  • stomach and intestinal (gastrointestinal) problems, including: diarrhea, nausea, vomiting, and stomach-area pain
  • tiredness, decreased appetite, and weight loss

Be sure to tell your heath care provider how you are feeling or if you have any concerns about your treatment, especially if you think you are experiencing any treatment side effects.

The recommended 450-mg daily dose of ZYKADIA with food had fewer and less severe gastrointestinal (GI) side effects compared with patients who took a higher dose on an empty stomach.

A few tips for managing some of the stomach and intestinal (gastrointestinal) side effects

You can try taking something to help these types of side effects, such as:

  • Medications to help with nausea or vomiting
  • Medications to help with diarrhea
  • Fluid replacement

Consult your health care provider to create an appropriate side effects management plan. Your health care provider may temporarily interrupt, reduce, or discontinue your dose of ZYKADIA.

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.