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Generic Name: ceritinib (se RI ti nib)
Brand Name: Zykadia

Medically reviewed on June 6, 2017

What is ceritinib?

Ceritinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Ceritinib is used to treat non-small cell lung cancer that has spread to other parts of the body. Ceritinib is used only if your tumor has a specific genetic marker, for which your doctor will test.

Ceritinib may also be used for purposes not listed in this medication guide.

Important Information

Ceritinib can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using ceritinib and for several months after your last dose, whether you are a man or a woman. Ceritinib use by either parent may cause birth defects.

Ceritinib can cause liver problems. Call your doctor right away if you have right-sided-stomach pain, nausea, loss of appetite, unusual tiredness, easy bruising or bleeding, dark urine, or yellowing of the skin or eyes.

Ceritinib can also cause lung or heart problems. Call your doctor right away if you have chest pain, dizziness, irregular heartbeats, trouble breathing, cough, fever, or if you feel light-headed.

Before taking this medicine

You should not use ceritinib if you are allergic to it.

To make sure ceritinib is safe for you, tell your doctor if you have ever had:

  • heart disease, a heart rhythm disorder, or long QT syndrome;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • a pancreas disorder;

  • diabetes or high blood sugar; or

  • liver disease.

Ceritinib can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Men should use condoms. Ceritinib use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 6 months after your last dose of ceritinib. If you are a man, keep using condoms for at least 3 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ceritinib.

It is not known whether ceritinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

How should I take ceritinib?

Ceritinib is usually taken once per day. Follow all directions on your prescription label. Do not use ceritinib in larger or smaller amounts or for longer than recommended.

Take ceritinib on an empty stomach, at least 1 hour before or 2 hours after a meal.

You may be given medication to prevent nausea or vomiting while you are receiving ceritinib.

If you vomit shortly after taking ceritinib, do not take another dose. Stay on your regular schedule.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. If you have heart disease, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ceritinib?

Grapefruit and grapefruit juice may interact with ceritinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking ceritinib.

Ceritinib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow heartbeats, weak pulse, weak or shallow breathing;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • severe diarrhea;

  • severe stomach pain, ongoing nausea or vomiting;

  • sudden chest pain or discomfort, fever, dry cough or cough with mucus, feeling short of breath;

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • signs of pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • liver problems--right-sided-stomach pain, nausea, loss of appetite, unusual tiredness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or

  • high blood sugar--increased thirst, increased urination, hunger, fruity breath odor, headaches, thinking problems, blurred vision, feeling tired.

Ceritinib usually causes side effects on your stomach (nausea, vomiting, diarrhea, stomach pain) that can be severe. Call your doctor if you have severe or ongoing stomach symptoms.

Common side effects may include:

  • stomach pain, loss of appetite;

  • nausea, vomiting, diarrhea;

  • feeling tired; or

  • weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ceritinib dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

750 mg orally once daily on an empty stomach.

Duration of therapy: Until disease progression or unacceptable toxicity

-If a dose is missed, make it up unless it is 12 hours or less until the next dose.
-Discontinue in patients unable to tolerate 300 mg a day.
-An improvement in survival or disease-related symptoms has not been established

Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

What other drugs will affect ceritinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with ceritinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.