When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to nilotinib, or if you are pregnant.

How to Use This Medicine:
Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Do not change your dose or stop using this medicine without checking first with your doctor.
• It is best to take this medicine on an empty stomach. Do not eat for 2 hours before or 1 hour after you take your dose.
• Drink extra water to help avoid possible side effects.
• Swallow the capsule whole with water. If you cannot swallow the capsule, you may open the capsule and sprinkle the contents over one teaspoon of applesauce. Do not mix with the medicine with any other food. Swallow the mixture right away. Do not save any of the mixture for later.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and take your next dose when you normally would. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

• Some foods and medicines can affect how nilotinib works. Tell your doctor if you are using any of the following:
  
  • Alfentanil, atazanavir, carbamazepine, chloroquine, clarithromycin, cyclosporine, dexamethasone, dihydroergotamine, ergotamine, esomeprazole, fentanyl, haloperidol, indinavir, itraconazole, ketoconazole, methadone, midazolam, nefazodone, nelfinavir, rifabutin, rifampin, rifampicin, rifapentine, ritonavir, phenobarbital, phenytoin, pimozide, saquinavir, sirolimus, St John's wort, tacrolimus, telithromycin, voriconazole, warfarin
  • Medicine for heart rhythm problems (such as amiodarone, disopyramide, procainamide, quinidine, sotalol)
• Do not take antacids at the same time as nilotinib. If you take medicine to block stomach acid production (such as cimetidine, famotidine, or ranitidine), take it 10 hours before or 2 hours after you take nilotinib. If you take an antacid that contains aluminum, magnesium, or simethicone, take it 2 hours before or 2 hours after you take nilotinib.
• 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.
• Tell your doctor if you are breastfeeding, or if you have liver disease, heart or blood vessel disease, heart rhythm problems (such as long QT syndrome), lung disease, a recent heart attack, or a history of pancreas problems or stroke. Tell your doctor if you had surgery to remove your stomach (total gastrectomy). Tell your doctor if you have problems with lactose.
• This medicine may cause the following problems:
  
  • Heart rhythm problems (such as QT prolongation)
  • Heart or blood vessel problems (such as decreased blood flow to your legs, heart, or brain)
  • Liver or pancreas problems
  • Tumor lysis syndrome (electrolyte and metabolic problems that can be life-threatening)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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.
• 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 an ECG test (electrocardiogram) to check your heart rhythm.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Change in how much or how often you urinate, blood in your urine
• Chest pain or trouble breathing, fast, pounding, or uneven heartbeat
• Confusion, weakness, muscle twitching
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting
• Fainting, dizziness, or lightheadedness
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Pain, swelling, or color changes in your leg
• Rapid weight gain, swelling of your hands, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting, fever
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

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

• Diarrhea or constipation
• Headache
• Joint or muscle pain
• Skin rash, itching, or dry skin

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