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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 (Nexterone, Pacerone); antifungals such as ketoconazole, itraconazole (Onmel, Sporanox), or voriconazole (Vfend); chloroquine (Plaquenil); clarithromycin (Biaxin, in Prevpac); disopyramide (Norpace); erythromycin (E.E.S., Eryc, PCE); 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 (Haldol); methadone (Dolophine, Methadose); moxifloxacin (Avelox); nefazodone; pimozide (Orap); procainamide; quinidine (in Nuedexta); sotalol (Betapace, Betapace AF, others); 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.
Do not eat any food for at least 2 hours before taking nilotinib and for 1 hour after taking this medication.
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.
WHY is this medicine prescribed?
Nilotinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) who have recently found to have this condition in adults and children 1 year of age and older. It is also used to treat certain types of CML whose disease could not be treated successfully with imatinib (Gleevec) or adults who cannot take imatinib. Nilotinib is also used to treat certain types of CML in children 1 year of age or older whose disease could not be treated successfully with other tyrosine kinase inhibitor therapies. 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.
HOW should this medicine be used?
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 2 hours before or 1 hour 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 nilotinib dose or stop your treatment depending on how well the medication works for you and if you experience any side effects. Continue to take nilotinib even if you feel well. Do not stop taking nilotinib without talking to your doctor.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking nilotinib,
What SPECIAL DIETARY instructions should I follow?
Do not eat grapefruit, drink grapefruit juice, or take any supplement containing grapefruit extract while taking this medication.
What should I do IF I FORGET to take a dose?
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Nilotinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
Nilotinib may cause children to grow more slowly. Your child's doctor will watch your child's growth carefully while your child is taking nilotinib. Talk to your child's doctor about the risks of giving this medication to your child.
Nilotinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What should I know about STORAGE and DISPOSAL of 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).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
What OTHER INFORMATION should I know?
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.
AHFS® Consumer Medication Information. © Copyright, 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.
Selected Revisions: April 15, 2018.
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