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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, or an irregular heartbeat. Your doctor may tell you not to take nilotinib. 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.
Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking nilotinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
Do not eat any food for at least 2 hours before and for 1 hour after taking nilotinib capsules.
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.
You will be given the 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 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). Nilotinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein in cancer cells. This helps to stop or slow the spread of cancer cells.
HOW should this medicine be used?
Nilotinib comes as a capsule and a tablet to take by mouth. Take twice a day. Take capsules 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.
Take nilotinib exactly as directed. Ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules and tablets 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. Tell your doctor if you are not able to swallow the tablets whole.
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.
Nilotinib tablets are used in different dosages than the capsules. Do not switch from one to the other without talking to your doctor.
Are there OTHER USES for this medication?
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 do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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 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).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reachhttp://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
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.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 15, 2025.