Medications and Drugs

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Brand Names: Tasigna

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

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

What is nilotinib (Tasigna)?

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

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

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.

Stop using nilotinib and call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out, fast or pounding heartbeat, seizure (convulsions);
• pale skin, weakness, feeling light-headed, rapid heart rate, trouble concentrating;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• feeling short of breath, even with mild exertion;
• swelling, rapid weight gain;
• redness or crusting around your hair follicles;
• sudden headache, confusion, or problems with vision;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe pain in your upper stomach spreading to your back; or
• cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath.

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

• mild skin rash or itching;
• diarrhea, constipation;
• headache, neck or back pain;
• weight changes;
• tired feeling; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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)?

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

You should not breast-feed while you are taking nilotinib.

Before using nilotinib, tell your doctor if you have heart disease or a heart rhythm disorder, liver disease, a personal history of pancreatitis, a family history of "Long QT syndrome," or if your stomach has been surgically removed (total gastrectomy).

You will need regular medical tests to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Call your doctor at once if you have a serious side effect such as feeling light-headed with a fast or pounding heartbeat, pale skin, easy bruising or bleeding, fever, flu symptoms, cough with stabbing chest pain, mouth sores, feeling light-headed or short of breath, swelling, sudden headache or vision problems, upper stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

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