Treats a cancer of the white blood cells called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) and accelerated phase (AP) after other treatments, such as imatinib (Gleevec®), have failed. Also used to treat newly diagnosed chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML-CP).
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 in your blood, or 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.
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- It is best to take this medicine on an empty stomach. Take the medicine at least 1 hour before or 2 hours after eating.
- Swallow the capsule whole with water. Do not open the capsule. If you cannot swallow the capsule whole, tell your doctor.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
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 double doses.
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 away from children and 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, rifapentin, 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, bepridil (Vascor®), 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
- Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
- Make sure your doctor knows if you have liver disease, blood or bone marrow problems, heart disease, heart rhythm problems, a history of pancreatitis (inflammation of the pancreas), or high potassium or low calcium, low phosphate, or low sodium 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.
- This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Tell your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
- This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
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, weakness, and muscle twitching.
- Dark-colored urine or pale stools.
- Dry mouth, increased thirst, or muscle cramps.
- Fast, pounding, or uneven heartbeat.
- Fever, chills, cough, sore throat, and body aches.
- Nausea, vomiting, loss of appetite, or pain in your upper stomach.
- Numbness or tingling in your hands, feet, or lips.
- Shortness of breath.
- Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness.
- 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:
- Back pain.
- Bone, joint, or muscle pain.
- Diarrhea, constipation, or stomach pain.
- Hair loss.
- Headache or dizziness.
- Runny or stuffy nose.
- 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
Review Date: 2011-02-04