Nilotinib may cause QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death). Tell your doctor if you or anyone in your family has or has ever had long QT syndrome (an inherited condition in which a person is more likely to have QT prolongation) or you have or have ever had low levels of potassium or magnesium in your blood, an irregular heartbeat, or liver disease. Tell your doctor and pharmacist if you are taking amiodarone (Cordarone, Pacerone); antifungals such as ketoconazole (Nizoral), itraconazole (Sporanox), or voriconazole (Vfend); chloroquine (Aralen); cisapride (Propulsid); clarithromycin (Biaxin, in Prevpac); disopyramide (Norpace); erythromycin (E.E.S., E-Mycin, Erythrocin); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); haloperidol; methadone (Dolophine, Methadose); moxifloxacin (Avelox); nefazodone; pimozide (Orap); procainamide (Procanbid, Pronestyl); quinidine; sotalol (Betapace, Betapace AF); telithromycin (Ketek); and thioridazine. If you experience any of the following symptoms, stop taking nilotinib and call your doctor immediately: fast, pounding, or irregular heartbeat; fainting; loss of consciousness; or seizures.
Take nilotinib on an empty stomach, at least 1 hour before or 2 hours after eating any food.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, such as blood tests and electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and during your treatment to be sure that it is safe for you to take nilotinib.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with nilotinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking nilotinib.
Nilotinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells), including treatment in people whose disease could not be treated successfully with imatinib (Gleevec) or people who cannot take imatinib. Nilotinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
Nilotinib comes as a capsule to take by mouth. It is usually taken without food twice a day. Nilotinib should be taken on an empty stomach, at least 1 hour before or 2 hours after eating any food. Take nilotinib at around the same times every day. Try to space your doses about 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nilotinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole with a glass of water; do not split, chew, or crush them. If you are not able to swallow the capsules whole, mix the contents of a capsule in one teaspoon of applesauce. Swallow the mixture immediately (within 15 minutes.) Do not store the mixture for future use.
Your doctor may decrease your dose of nilotinib during your treatment. This will depend on how well the medication works for you and any side effects you may experience. Continue to take nilotinib even if you feel well. Do not stop taking nilotinib without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Do not eat grapefruit, drink grapefruit juice, or take any supplement containing grapefruit extract while taking this medication.
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
loss of appetite
difficulty falling asleep or staying asleep
back, bone, joint, limb, or muscle pain
dry or reddened skin
numbness, burning, or tingling in the hands or feet
unusual bleeding or bruising
blood in urine
bloody or black, tarry stools
unusual tiredness or weakness
fever, chills, sore throat, ongoing cough and congestion, or other signs of infection
shortness of breath
swelling of hands, ankles, feet, or face
sudden stomach area pain
yellowing of the skin and eyes
Nilotinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
fever, sore throat, chills, or other signs of infection
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 05/15/2014
AHFS® Consumer Medication Information. © Copyright, 2014. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.