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Ceritinib

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

Ceritinib is used for:

Treating a certain type of lung cancer. It may also be used for other conditions as determined by your doctor.

Ceritinib is a kinase inhibitor. It works by killing the cancer cells.

Do NOT use ceritinib if:

  • you are allergic to any ingredient in ceritinib
  • you are taking carbamazepine, phenytoin, rifampin, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using ceritinib:

Some medical conditions may interact with ceritinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems, lung or breathing problems, diabetes or high blood sugar, abnormal blood electrolyte levels (eg, potassium, sodium), or heart problems (eg, heart failure, slow heartbeat, a type of irregular heartbeat called long QT syndrome)
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with ceritinib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone) because the risk of high blood sugar may be increased
  • Beta-blockers (eg, propranolol), clonidine, digoxin, diltiazem, or verapamil because they may increase the risk of slow heartbeat may be increased
  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), nefazodone, protease inhibitors (eg, ritonavir), or telithromycin because they may increase the risk of ceritinib's side effects
  • Alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or warfarin because the risk of their side effects may be increased by ceritinib
  • Carbamazepine, phenytoin, rifampin, or St. John's wort because they may decrease ceritinib's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if ceritinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ceritinib:

Use ceritinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take ceritinib on an empty stomach, at least 2 hours before or 2 hours after a meal.
  • Do not eat grapefruit or drink grapefruit juice while you use ceritinib.
  • Continue to use ceritinib as you have been told, even if you feel well. Do not miss any doses.
  • If you miss a dose of ceritinib, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses at once or extra doses.

Ask your health care provider any questions you may have about how to use ceritinib.

Important safety information:

  • Tell your doctor or dentist that you take ceritinib before you receive any medical or dental care, emergency care, or surgery.
  • If you have nausea, vomiting, or diarrhea, talk with your doctor. There be ways to lessen these side effects.
  • Ceritinib may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Check your blood sugar as you have been told by your doctor.
  • Severe and sometimes fatal lung or breathing problems have happened with ceritinib. Call your doctor right away if you have new or worsening trouble breathing, shortness of breath, or cough.
  • You will need to have your blood pressure and heart rate checked often while taking ceritinib. Talk with your doctor.
  • You may need to have an electrocardiogram (ECG) checked while taking ceritinib. Talk with your doctor.
  • Lab tests may be performed while you use ceritinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • If you may become pregnant, use an effective form of birth control while you take ceritinib and for at least 2 weeks after you stop it. If you have questions about effective birth control, talk with your doctor.
  • PREGNANCY and BREAST-FEEDING: Ceritinib may cause harm to the fetus. Avoid becoming pregnant while you take ceritinib and for at least 2 weeks after you stop it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using ceritinib while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking ceritinib.

Possible side effects of ceritinib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; decreased appetite; diarrhea; heartburn; nausea; stomach pain; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); burning, numbness, or tingling; change in balance; chest pain or discomfort; dizziness or light-headedness; fainting; fast, slow, or irregular heartbeat; muscle weakness; severe or persistent nausea, vomiting, or diarrhea; symptoms of liver problems (eg, dark urine; feeling tired; unusual loss of appetite, nausea, or vomiting; right-sided stomach pain; pale stools; yellowing of the skin or eyes; easy bruising or bleeding); vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ceritinib:

Store ceritinib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep ceritinib out of the reach of children and away from pets.

General information:

  • If you have any questions about ceritinib, please talk with your doctor, pharmacist, or other health care provider.
  • Ceritinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ceritinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ceritinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ceritinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using ceritinib.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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