Zykadia

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

What is Zykadia?

Zykadia (ceritinib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

Zykadia 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 Zykadia can improve symptoms or lengthen survival time.

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

Important information

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.

Slideshow: Flashback: FDA Drug Approvals 2013

Before taking this medicine

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

To make sure Zykadia 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);

  • diabetes; or

  • liver disease.

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

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Zykadia.

How should I take Zykadia?

Zykadia 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 Zykadia 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 Zykadia.

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.

Zykadia 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

Comments:
-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 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 Zykadia?

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

Zykadia side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Zykadia: 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);

  • 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 Zykadia 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.

See also: Side effects (in more detail)

What other drugs will affect Zykadia?

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 Zykadia, especially:

  • St. John's wort;

  • an antibiotic - clarithromycin, rifampin, telithromycin;

  • cancer medicine - arsenic trioxide, enzalutamide, mitotane, nilotinib, toremifene, vandetanib, vemurafenib;

  • an antidepressant - citalopram, nefazodone;

  • anti-fungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;

  • anti-malaria medication - lumefantrine;

  • heart rhythm medicine - amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol;

  • hepatitis C medicine - boceprevir, telaprevir;

  • HIV or AIDS medicine - atazanavir, cobicistat (Stribild), delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir;

  • medicine to treat a psychiatric disorder - iloperidone, pimozide, thioridazine, ziprasidone, others; or

  • seizure medicine - carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone.

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 Zykadia.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zykadia only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-07-15, 8:27:24 AM.

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