Generic Name: nilotinib (nye LOE ti nib)
Brand Name: Tasigna

What is nilotinib?

Nilotinib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

Nilotinib is usually given after other medications have been tried without success.

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

What is the most important information I should know about nilotinib?

You should not use nilotinib if you have low blood levels of potassium or magnesium, or a heart rhythm disorder called Long QT syndrome.

Before and during your treatment with nilotinib, your heart function may be checked with an electrocardiograph or ECG (sometimes called an EKG), and you may need frequent blood tests.

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Some medicines can cause unwanted or dangerous effects when used with nilotinib. Your doctor may need to change your treatment plan if you use any of the following drugs: chloroquine, methadone, nefazodone, an antibiotic--clarithromycin, moxifloxacin, telithromycin; antifungal medication--itraconazole, ketoconazole, voriconazole; heart rhythm medicine--amiodarone, disopyramide, dronedarone, procainamide, quinidine, sotalol; HIV or AIDS medicine--atazanavir, indinavir, nelfinavir, ritonavir, saquinavir; or medicine to treat a psychiatric disorder--haloperidol, pimozide, thioridazine, ziprasidone.

Take nilotinib on an empty stomach. Avoid eating anything for at least 2 hours before and 1 hour after you take nilotinib.

What should I discuss with my healthcare provider before taking nilotinib?

You should not use nilotinib if you are allergic to it, or if you have:

  • low blood levels of potassium or magnesium; or

  • a heart rhythm disorder called long QT syndrome.

Some medicines can cause unwanted or dangerous effects when used with nilotinib. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • chloroquine, methadone, nefazodone; or

  • an antibiotic--clarithromycin, moxifloxacin, telithromycin; antifungal medication--itraconazole, ketoconazole, voriconazole; heart rhythm medicine--amiodarone, disopyramide, dronedarone, procainamide, quinidine, sotalol; HIV or AIDS medicine--atazanavir, indinavir, nelfinavir, ritonavir, saquinavir; or medicine to treat a psychiatric disorder--haloperidol, pimozide, thioridazine, ziprasidone.

To make sure nilotinib is safe for you, tell your doctor if you have any of these conditions:

  • heart disease, heart rhythm problems;

  • a personal or family history of Long QT syndrome;

  • liver disease;

  • a history of pancreatitis; or

  • if your stomach has been surgically removed (total gastrectomy).

Nilotinib capsules may contain lactose. Talk to your doctor before using this medication if you have galactose intolerance, or severe problems with lactose (milk sugar).

FDA pregnancy category D. Do not use nilotinib if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy, and tell your doctor if you become pregnant during treatment.

It is not known whether nilotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking nilotinib.

How should I take nilotinib?

Nilotinib is usually taken every 12 hours. Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water. Swallow the nilotinib capsule whole.

Take nilotinib on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take with food. Food can increase your blood levels of nilotinib and may increase your risk of harmful side effects.

To make swallowing easier, you may open the nilotinib capsule and sprinkle the medicine into no more than 1 teaspoon of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Avoid eating anything for at least 2 hours before and 1 hour after you take nilotinib.

Nilotinib is to be taken long-term. You should not stop using nilotinib suddenly. Stopping suddenly may make your condition worse.

Nilotinib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your heart function may be checked with an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. 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.

Overdose symptoms may include drowsiness and vomiting.

What should I avoid while taking nilotinib?

Avoid taking a stomach acid reducers (Axid, Pepcid, Tagamet, Zantac, and others) within 10 hours before or 2 hours after you take nilotinib.

Avoid taking an antacid (Di-Gel, Gaviscon, Maalox, Milk of Magnesia, Mylanta, Rolaids, and others) within 2 hours before or 2 hours after you take nilotinib.

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

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Nilotinib side effects

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

Stop using nilotinib and call your doctor at once if you have:

  • bone marrow suppression--fever, chills, painful mouth sores, pale skin, easy bruising or bleeding, red or pink urine, bloody or tarry stools, cough, trouble breathing, feeling light-headed, rapid heart rate;

  • kidney problems--lower back pain, little or no urinating;

  • pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting;

  • high or low potassium---confusion, slow or uneven heart rate, weak pulse, extreme thirst, increased urination, leg discomfort, tingly feeling, muscle weakness or limp feeling;

  • low calcium--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;

  • low sodium--headache, confusion, slurred speech, hallucinations, vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, seizure (convulsions), shallow breathing;

  • liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • bleeding in the brain--sudden headache, confusion, vision problems, and feeling like you might pass out.

Common side effects may include:

  • diarrhea, constipation, stomach discomfort;

  • mild itching or rash, temporary hair loss;

  • runny or stuffy nose, sneezing, sore throat;

  • mild headache, back pain, joint or muscle pain; or

  • tired feeling.

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 nilotinib?

Many drugs can interact with nilotinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with nilotinib. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about nilotinib.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication 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 1996-2012 Cerner Multum, Inc. Version: 14.02. Revision Date: 2013-08-26, 7:55:35 AM.

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