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Nilotinib (By mouth)

Nilotinib (nye-LOE-ti-nib)

Treats leukemia. This is an antineoplastic (cancer) medicine.

Brand Name(s):


There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to nilotinib, or if you are pregnant or breastfeeding. Do not use this medicine if you have low potassium or magnesium levels in your blood, or if you have a heart rhythm problem called long QT syndrome.

How to Use This Medicine:


  • Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • It is best to take this medicine on an empty stomach. Take the medicine at least 1 hour before or 2 hours after eating.
  • Drink extra water to help avoid possible side effects. If you have a dry mouth or feel thirsty, then you need to drink more fluids.
  • Swallow the capsule whole with water. If you cannot swallow the capsule whole, the capsules can be opened and the contents can be sprinkled in one teaspoon of applesauce. Swallow the mixture right away (within 15 minutes). Do not keep any of the mixture to use later.
  • Do not change your dose or stop using this medicine without checking first with your doctor.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using certain antibiotics (such as clarithromycin, moxifloxacin, rifabutin, rifampin, rifapentine, telithromycin, Avelox®, Biaxin®, Ketek®, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), medicine to treat fungal infections (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), or medicine to treat HIV or AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Reyataz®, or Viracept®).
  • Tell your doctor if you are also using St John's wort, dexamethasone (Decadron®), haloperidol (Haldol®), methadone (Dolophine®), nefazodone (Serzone®), or pimozide (Orap®). Make sure your doctor knows if you are also using a blood thinner (such as warfarin, Coumadin®), medicine for seizures (such as carbamazepine, midazolam, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Versed®), stomach medicine (such as esomeprazole, Nexium®, Prevacid®, or Prilosec®), medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol, Betapace®, Cordarone®, or Tikosyn®), or medicine to treat malaria (such as chloroquine, halofantrine, Aralen®, or Halfan®).
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
  • Make sure your doctor knows if you have liver disease, blood or bone marrow problems, heart disease, heart rhythm problems, or a history of pancreatitis (inflammation of the pancreas). Tell your doctor if you know that you have high potassium, low calcium, low phosphate, or low sodium levels in your blood. Tell your doctor if you have had a surgery that involves the removal of the entire stomach (total gastrectomy).
  • This medicine contains lactose. Tell your doctor if you have problems when taking lactose.
  • Contact your doctor right away if you have any changes to your heart rhythm. Some possible symptoms are dizziness, fainting, or a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
  • This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Avoid people who are ill, and wash your hands often. Brush and floss your teeth gently, do not play rough sports, and be careful with sharp objects.
  • Call your doctor right away if you have pain in your lower back or side, a change in how much or how often you urinate, rapid weight gain, swelling in your feet or legs, or unusual tiredness or weakness. This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. You will also need to have your heartbeat checked with an ECG test (electrocardiogram).

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Blood in the urine or stool
  • Change in how much or how often you urinate
  • Confusion, body weakness, and muscle twitching
  • Dark-colored urine or pale stools
  • Fainting, dizziness, lightheadedness
  • Fast, pounding, or uneven heartbeat
  • Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach
  • Rapid weight gain
  • Shortness of breath
  • Sudden and severe stomach pain, vomiting, fever
  • Swelling in your hands, ankles, or feet
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

  • Diarrhea or constipation
  • Headache
  • Joint or muscle pain
  • Skin rash or itching

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 4/4/2014

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