Nilotinib (nye-LOE-ti-nib)

Treats leukemia.

Brand Name(s):

Tasigna

When This Medicine Should Not Be Used:

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 at least 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 it and sprinkle the contents over one teaspoon of applesauce (puréed apple). Do not mix the medicine with any other food. Swallow the mixture right away within 15 minutes. Do not save any of the mixture for later use.
• 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 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, phenobarbital, phenytoin, pimozide, rifabutin, rifampin, rifampicin, rifapentine, ritonavir, saquinavir, sirolimus, St John's wort, tacrolimus, telithromycin, voriconazole, warfarin
  • Medicine for heart rhythm problems (including amiodarone, disopyramide, procainamide, quinidine, sotalol)
  • Proton pump inhibitor (including esomeprazole)
• If you are also using medicine to block stomach acid production (including cimetidine, famotidine, or ranitidine), take it at least 10 hours before or 2 hours after you take nilotinib. If you are using an antacid that contains aluminum, magnesium, or simethicone, take it at least 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. Use an effective form of birth control during treatment with this medicine and for at least 14 days after your last dose.
• Do not breastfeed during treatment with this medicine and for at least 14 days after the last dose.
• Tell your doctor if you have liver disease, heart or blood vessel disease, heart rhythm problems (including 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) or if you have problems with lactose.
• This medicine may cause the following problems:
  • Heart rhythm problems (including QT prolongation)
  • Heart or blood vessel problems (including decreased blood flow to your legs, heart, or brain)
  • Pancreatitis (swelling of pancreas)
  • Liver problems
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
  • Increased risk of bleeding
• 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.
• After at least 3 years of treatment with this medicine, your doctor may do certain tests to check if you continue to show no symptoms of your cancer (remission) and may let you stop taking it. However, you may need to restart treatment, at a later time, if you are no longer in remission.
• 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
• Fainting, dizziness, or lightheadedness
• Fever, chills, cough, runny or stuffy nose, sore throat, 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
• 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, 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