Nilotinib Oral capsule

What is this medicine?

NILOTINIB (nil OT i nib) is a chemotherapy drug. It targets a specific protein within cancer cells and stops the cells from growing. This medicine is used to treat chronic myelogenous leukemia (CML).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes
• heart disease
• history of pancreatitis
• immune system problems
• infection (especially a virus infection such as chickenpox, cold sores, or herpes)
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• low magnesium or potassium levels in the body
• QT prolongation
• an unusual or allergic reaction to nilotinib, lactose, gelatin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, do not make up the missing dose. Take your next dose as scheduled. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• amoxapine
• astemizole
• bupivacaine
• cisapride
• clozapine
• cyclobenzaprine
• disopyramide
• droperidol
• flecainide
• grapefruit or grapefruit juice
• halofantrine
• haloperidol
• maprotiline
• methadone
• perphenazine
• pimozide
• quinidine
• ranolazine
• risperidone
• sunitinib
• tacrolimus
• terfenadine
• thioridazine
• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS
• certain antibiotics like clarithromycin, erythromycin, telithromycin, troleandomycin
• dexamethasone
• medicines for blood pressure, heart disease, irregular heart beat
• medicines for depression, anxiety, or psychotic disturbances
• medicines for fungal infections like ketoconazole, itraconazole, voriconazole, fluconazole
• medicines for seizures like carbamazepine, phenobarbital, phenytoin
• medicines for sleep
• mifepristone
• propoxyphene
• rifabutin
• rifampin
• rifapentine
• St. John's Wort
• tamoxifen
• warfarin
• zafirlukast

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for checks on your progress. You will need to have regular blood tests while on this medicine. Report any new symptoms promptly.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or palpitations
• dizziness or fainting
• fast, irregular heartbeat
• fever or chills, sore throat
• increased hunger or thirst
• increased urination
• light-colored stools
• swelling of the ankles, feet, hands
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• headache
• loss of appetite
• nausea, vomiting
• muscle aches
• stomach pain
• trouble sleeping
• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.