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

Zykadia is used to treat non-small cell lung cancer that has spread to other parts of the body.

Zykadia is used only if your cancer has a specific genetic marker. Your doctor will test you for this gene.

Zykadia can harm an unborn baby. Both men and women using Zykadia should use effective birth control to prevent pregnancy. Keep using birth control for at least 6 months after your last dose of ceritinib if you are a woman, or 3 months after your last dose if you are a man.

Tell your doctor if you have severe or ongoing stomach symptoms (nausea, vomiting, diarrhea, stomach pain).

Zykadia can cause serious side effects on your heart, lungs, or liver. Call your doctor right away if you have: right-sided-stomach pain, loss of appetite, bruising or bleeding, dark urine, yellowing of your skin or eyes, fever, cough, chest pain, irregular heartbeats, shortness of breath, or sudden dizziness.

Zykadia is usually taken once per day with food. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you vomit shortly after taking Zykadia, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

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

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Zykadia is usually given until your body no longer responds to the medication.

Store at room temperature away from moisture and heat.

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.

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

Tell your doctor if you have ever had:

• heart problems;

• long QT syndrome (in you or a family member);

• 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.

Zykadia can harm an unborn baby if the mother or the father is taking this medicine.

• If you are a woman, do not use ceritinib if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control 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.

You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

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

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

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

Zykadia 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.

Also call your doctor at once if you have:

• severe pain in your upper stomach spreading to your back;

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

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

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

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

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• liver problems - right-sided-stomach pain, loss of appetite, unusual tiredness, itching, easy bruising or bleeding, dark urine, or yellowing of the skin or eyes.

Common Zykadia 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.

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 here. Tell your doctor about all your current medicines and any medicine you start or stop using.