ceritinib

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Pronunciation: se RI ti nib

Brand: Zykadia

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is ceritinib?

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

Ceritinib is used to treat non-small cell lung cancer caused by a defect in a certain gene. Ceritinib is used when the cancer has spread to other parts of the body. Ceritinib is usually given after other cancer medicines have been tried without success.

Ceritinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, non-small cell lung tumors responded to this medicine. However, it has not been shown that ceritinib can improve symptoms or lengthen survival time.

Ceritinib is available only from a certified pharmacy. You must be registered in the program and understand the risks of taking this medicine.

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

What should I discuss with my healthcare provider before taking ceritinib?

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:

  • congestive heart failure;
  • 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.

Do not use ceritinib if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control while you are using this medicine and for at least 2 weeks after your treatment ends.

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.

How should I take ceritinib?

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

Take ceritinib on an empty stomach. Do not eat within 2 hours before or 2 hours after you take this medicine.

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

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.

What are the possible side effects of ceritinib?

Get emergency medical help if you have any of these 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 --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

  • stomach pain, loss of appetite;
  • nausea, vomiting;
  • diarrhea, constipation;
  • tired feeling; or
  • abnormal liver tests (high liver enzyme levels).

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.

What other drugs will affect ceritinib?

Many drugs can interact with ceritinib. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with ceritinib, especially:

  • celecoxib;
  • nefazodone;
  • St. John's wort;
  • tolbutamide;
  • warfarin (Coumadin, Jantoven);
  • an antibiotic --clarithromycin, telithromycin;
  • antifungal medicine --itraconazole, ketoconazole, posaconazole, voriconazole;
  • heart or blood pressure medicine --nicardipine, quinidine;
  • antiviral medicine to treat hepatitis or HIV/AIDS --atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir;
  • seizure medicine --carbamazepine, phenytoin; or
  • tuberculosis medicine --isoniazid, rifampin.

This list is not complete and many other drugs can interact with ceritinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about ceritinib.

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.

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