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Brand Names: Tasigna

Generic Name: nilotinib (Pronunciation: nye LOE ti nib)

• What is nilotinib (Tasigna Capsules)?
• What are the possible side effects of nilotinib (Tasigna Capsules)?
• What is the most important information I should know about nilotinib (Tasigna Capsules)?
• What should I discuss with my healthcare provider before taking nilotinib (Tasigna Capsules)?
• How should I take nilotinib (Tasigna Capsules)?
• What happens if I miss a dose (Tasigna Capsules)?
• What happens if I overdose (Tasigna Capsules)?
• What should I avoid while taking nilotinib (Tasigna Capsules)?
• What other drugs will affect nilotinib (Tasigna Capsules)?
• Where can I get more information?

What is nilotinib (Tasigna Capsules)?

Nilotinib interferes with the growth of some cancer cells.

Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML).

Nilotinib is usually given to people who cannot take certain other leukemia medications, or who have tried other medications without successful treatment.

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

What are the possible side effects of nilotinib (Tasigna Capsules)?

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

Call your doctor at once if you have any of these serious side effects:

• dizziness and fast or pounding heartbeat;
• shortness of breath;
• swelling in your hands or feet;
• seizure (convulsions);
• warmth, redness, or tingly feeling under your skin;
• nausea, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe pain in your upper stomach spreading to your back; or
• dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, muscle pain or weakness, uneven heart rate, or feeling like you might pass out.

Less serious side effects may be more likely to occur, such as:

• skin rash or itching;
• diarrhea, constipation;
• headache, spinning sensation;
• tired feeling;
• numbness or tingling;
• sleep problems (insomnia);
• joint or muscle pain; or
• runny or stuffy nose, cough, sore throat, hoarseness.

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 is the most important information I should know about nilotinib (Tasigna Capsules)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not use nilotinib while you are breast-feeding a baby.

You should not use this medication if you are allergic to nilotinib, or if you have low blood levels of potassium or magnesium, or a history of "Long QT syndrome."

Before using nilotinib, tell your doctor if you have heart disease or a heart rhythm disorder, liver disease, a personal history of pancreatitis, or a family history of "Long QT syndrome." Tell your doctor about all other medications you use.

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

Call your doctor at once if you have any serious side effects, such as dizziness, fainting, fast or pounding heartbeat, feeling short of breath, swelling, seizure, warmth, redness, or tingly feeling under your skin, jaundice (yellowing of the skin or eyes), or severe pain in your upper stomach spreading to your back, with nausea and vomiting.

There are many other medicines that can cause interact with nilotinib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

To be sure this medication is not causing harmful effects, your blood and bone marrow will need to be tested on a regular basis. Your heart rate may also be checked using electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Do not miss any scheduled appointments.