Full Prescribing Information

Expand ISIIMPORTANT SAFETY INFORMATION ABOUT ZYKADIA™ (ceritinib) CAPSULES AND INDICATION

Expand ISIIMPORTANT SAFETY INFORMATION AND INDICATION

ZYKADIA may cause serious side effects, such as:

  • Stomach and intestinal 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.

IMPORTANT SAFETY INFORMATION ABOUT ZYKADIA™ (ceritinib) CAPSULES AND INDICATION

IMPORTANT SAFETY INFORMATION AND INDICATION

  • ZYKADIA may cause serious side effects, such as:
  • Stomach and intestinal 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 doctor right away if you experience any of the following symptoms:
    • Tiredness (fatigue)
    • Yellowing of skin or the whites of eyes
    • Decreased appetite
    • Urine turns dark or brown
    • Itchy skin
    • Nausea or vomiting
    • Pain on the right side of your stomach
    • 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 doctor right away if you have any new or worsening symptoms, including:
    • Trouble breathing or shortness of breath
    • Cough, with or without mucous
    • 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, 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. Follow your health care provider's instructions about monitoring your blood sugar. Call your health care provider right away if you have any symptoms of high blood sugar, including:
    • Increased thirst
    • Urinating often
    • Increased hunger
    • Blurred vision
    • Headaches
    • Tiredness
    • Trouble thinking or concentrating
    • Your breath smells like fruit

Before you take ZYKADIA, tell your doctor about all of your medical conditions, including if you:

  • Have liver problems
  • Have diabetes or high blood sugar
  • Have heart problems, including a condition called long QT syndrome
  • Are pregnant, think you may be pregnant, or plan to become pregnant. ZYKADIA may harm your unborn baby
  • Women who are able to become pregnant must use an effective method of birth control during treatment with ZYKADIA and for at least 2 weeks after stopping ZYKADIA. Talk to your health care provider about birth control methods that may be right for you
  • Are breastfeeding or plan to breastfeed

It is not known if ZYKADIA passes into your breast milk. You should not breastfeed if you take ZYKADIA.

It is not known if ZYKADIA passes into your breast milk. You should not breastfeed if you take ZYKADIA.

Tell your doctor about the medicines you take, including:

  • Prescription medicines
  • Vitamins
  • Over-the-counter medicines
  • Herbal supplements

The most common side effects of ZYKADIA include:

  • Diarrhea
  • Stomach-area pain
  • Constipation
  • Nausea
  • Tiredness (fatigue)
  • Vomiting
  • Decreased appetite

Tell your doctor 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 doctor 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.

How to take ZYKADIA and what to avoid

  • Take ZYKADIA exactly as your health care provider tells you. Do not change your dose or stop taking unless your health care provider tells you to
  • Take ZYKADIA 1 time each day
  • Take ZYKADIA on an empty stomach, do not eat for 2 hours before and do not eat for 2 hours after taking ZYKADIA
  • If you miss a dose of ZYKADIA, take it as soon as you remember. If your next dose is due within 12 hours, then skip the missed dose. Just take the next dose at your regular time
  • You should not drink grapefruit juice or eat grapefruit during treatment with ZYKADIA. It may make the amount of ZYKADIA in your blood increase to a harmful level

INDICATION

ZYKADIA™ (ceritinib) capsules is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:

  • Is caused by a defect in a gene called anaplastic lymphoma kinase (ALK), and
  • Has spread to other parts of the body, and
  • Who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib

The effectiveness of ZYKADIA in these patients is based on a study that measured two types of response to treatment (response rate and duration of response). There is no clinical information available to show if patients treated with ZYKADIA live longer or if their symptoms improve. There are ongoing studies to find out how ZYKADIA works over a longer period of time.

It is not known if ZYKADIA is safe and effective in children.

Please see the full Prescribing Information and the Patient Information for ZYKADIA™ (ceritinib) capsules.

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