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ZYKADIA is a NEW FDA-APPROVED 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 is based on response rate and duration of response. There are no data demonstrating an improvement in patient reported outcomes or survival with ceritinib.

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IMPORTANT INFORMATION AND INDICATION FOR ZYKADIA™ (ceritinib) CAPSULES

What is the most important information I should know about ZYKADIA?

ZYKADIA may cause serious side effects, including:

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 health care provider right away if you get any of the following:

  • you feel tired
  • your skin or the whites of your eyes turn yellow
  • you have a decreased appetite
  • your urine turns dark or brown (tea color)
  • have itchy skin
  • you have nausea or vomiting
  • you have pain on the right side of your stomach-area
  • 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
  • fever
  • cough with or without mucous
  • 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.

See "What are possible side effects of ZYKADIA?" for more information about side effects.

What is ZYKADIA?

ZYKADIA 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

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

What should I tell my health care provider before taking ZYKADIA?

Before you take ZYKADIA, tell your health care provider 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 or plan to become pregnant. ZYKADIA may harm your unborn baby. Women that are able to become pregnant should use an effective method of birth control during treatment with ZYKADIA and for up to 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

Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

How should I take ZYKADIA?

  • 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

What should I avoid while taking ZYKADIA?

  • 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

What are the possible side effects of ZYKADIA?

ZYKADIA may cause serious side effects, including:

  • See "What is the most important information I should know about ZYKADIA?"
  • 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

The most common side effects of ZYKADIA include:

  • stomach and intestinal problems. See "What is the most important information I should know about ZYKADIA?"
  • tiredness, decreased appetite, and constipation

These are not all of the possible side effects of ZYKADIA. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ZYKADIA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZYKADIA 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 health care provider or pharmacist for more information about ZYKADIA.

Click here for full Prescribing Information.