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What is nilotinib?

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 is the most important information I should know about nilotinib?

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."

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.

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.

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

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 are allergic to any drugs, or if you have:

• heart disease or heart rhythm disorder;

• liver disease;

• a personal history of pancreatitis; or

• a family history of "Long QT syndrome."

If you have any of these conditions, you may need a dose adjustment or special tests to safely take nilotinib.

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).

How should I take nilotinib?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Nilotinib is usually taken every 12 hours.

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.

What happens if I miss a dose?

Skip the missed dose and take your next dose at the regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an nilotinib overdose may include severe muscle cramps.

What should I avoid while taking nilotinib?

Avoid eating for at least 1 hour after you take this medication. Food can increase your blood levels of nilotinib and may increase your risk of harmful side effects.

Grapefruit and grapefruit juice may interact with nilotinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Nilotinib side effects

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 other drugs will affect nilotinib?

Before taking nilotinib, tell your doctor if you are using any of the following drugs:

• arsenic trioxide (Trisenox);

• chloroquine (Arelan) or halofantrine (Halfan);

• droperidol (Inapsine);

• midazolam (Versed);

• a blood thinner such as warfarin;

• HIV/AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);

• narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), pentamidine (NebuPent, Pentam), rifampin (Rifadin, Rifamate, Rimactane), or troleandomycin (Tao);

• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);

• an antidepressant such as amitriptyline (Elavil, Etrafon), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), and others;

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), or thioridazine (Mellaril); or

• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace).

This list is not complete and there may be other drugs that can 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.

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.
• 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.