What is the most important information I should know about nilotinib?
You should not use nilotinib if you have long QT syndrome, or low blood levels of potassium or magnesium.
Nilotinib can cause a serious heart problem, especially if you use certain other medicines at the same time. Tell your doctor about all your other medicines. Your heart function may need to be checked before and during treatment with nilotinib.
Call your doctor right away or get emergency medical help if you have fast or pounding heartbeats and sudden dizziness (like you might pass out).
Take nilotinib on an empty stomach. Avoid eating anything for at least 2 hours before and 1 hour after you take nilotinib.
What is nilotinib?
Nilotinib is a cancer medicine 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 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.
To make sure nilotinib is safe for you, tell your doctor if you have ever had:
- heart disease, heartbeat problems, or long QT syndrome (in you or a family member);
- a stroke;
- unusual bleeding;
- low blood levels of potassium or magnesium;
- severe problems with lactose (milk sugar);
- liver disease;
- pancreatitis; or
- surgical removal of your stomach (total gastrectomy).
Do not use nilotinib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are taking nilotinib.
It is not known whether nilotinib passes into breast milk or if it could affect 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 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 harmful side effects.
Take this medicine with a full glass of water. Swallow the capsule whole.
To make swallowing easier, you may open the 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 unless your doctor tells you to.
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.
Nilotinib can cause a serious heart problem. Your heart function may be checked with an electrocardiograph or ECG (sometimes called an EKG) before and during your treatment with nilotinib.
Store at room temperature away from moisture and heat.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
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?
Grapefruit and grapefruit juice may interact with nilotinib and cause unwanted side effects. Avoid the use of grapefruit products while taking nilotinib.
Avoid taking a stomach acid reducer (such as Pepcid, Tagamet, or Zantac) within 10 hours before or 2 hours after you take nilotinib.
Avoid taking an antacid (such as Di-Gel, Gaviscon, Maalox, Milk of Magnesia, Mylanta, or Rolaids) within 2 hours before or 2 hours after you take nilotinib.
Nilotinib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's 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.
What are the possible side effects of nilotinib?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Contact your doctor right away or get emergency medical help if you have symptoms of a serious heart problem: fast or pounding heartbeats and sudden dizziness (like you might pass out).
Call your doctor at once if you have:
- unusual bleeding (bruises, blood in your urine or stools);
-
bleeding in the brain --sudden headache, confusion, vision problems, and dizziness;
- swelling, rapid weight gain, feeling short of breath;
-
signs of liver or pancreas problems --upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
-
low blood cell counts --fever, chills, night sweats, mouth sores, pale skin, unusual weakness;
-
signs of decreased blood flow --leg pain or cold feeling, chest pain, numbness, trouble walking, speech problems; or
-
signs of tumor cell breakdown --little or no urination, muscle weakness or twitching, fast or slow heart rate, hallucinations, feeling restless or irritable.
Common side effects may include:
- low blood cell counts;
- nausea, vomiting, diarrhea, constipation;
- rash, temporary hair loss;
- runny or stuffy nose, sneezing, cough, sore throat;
- headache, joint or muscle pain; or
- feeling tired.
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?
Nilotinib can cause a serious heart problem, especially if you use certain medicines at the same time, such as antibiotics, antifungal medicine, antidepressants, anti-malaria medicine, asthma inhalers, antipsychotic medicine, cancer medicine, certain HIV/AIDS medicine, heart or blood pressure medicine, or medicine to prevent vomiting.
This list is not complete and many other drugs can interact with nilotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
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.
Copyright 1996-2018 Cerner Multum, Inc. Version: 17.01. Revision date: 9/19/2017.
