Nilotinib Oral Capsule

What is this medicine?

NILOTINIB (nil OT i nib) is a medicine that targets proteins in cancer cells and stops the cells from growing. It is used to treat chronic myelogenous leukemia (CML).

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 or with grapefruit juice. Take H2-blockers at least 10 hours before or 2 hours after this medicine. Avoid taking antacids within 2 hours of taking this medicine. Do not cut, crush, or chew this medicine. If you cannot swallow the capsules whole, you may open the capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce. Immediately swallow the mixture. Do not store for future use.

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. While this drug may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

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

• confusion, trouble speaking or understanding

• dizziness or fainting

• fast, irregular heartbeat

• fever or chills, sore throat

• light-colored stools

• pain, swelling, warmth in the leg

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.

• sudden numbness or weakness of the face, arm or leg

• swelling of the ankles, feet, hands

• trouble walking, dizziness, loss of balance or coordination

• unusually weak

• weight gain

• 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

What may interact with this medicine?

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

• cisapride

• dronedarone

• flibanserin

• fluconazole

• lomitapide

• pimozide

• posaconazole

• saquinavir

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antacids

• antiviral medicines for HIV or AIDS

• certain antibiotics like clarithromycin, erythromycin, telithromycin, troleandomycin

• dexamethasone

• dofetilide

• grapefruit or grapefruit juice

• medicines for blood pressure, heart disease, irregular heart beat

• medicines for depression, anxiety, or psychotic disturbances

• medicines for fungal infections like ketoconazole, itraconazole, voriconazole

• medicines for seizures like carbamazepine, phenobarbital, phenytoin

• medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole

• medicines for sleep

• mifepristone

• other medicines that prolong the QT interval (an abnormal heart rhythm)

• propoxyphene

• rifabutin

• rifampin

• rifapentine

• St. John's Wort

• tamoxifen

• warfarin

• zafirlukast

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.

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.

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

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

• circulation problems in legs

• diabetes

• heart disease

• history of irregular heartbeat

• history of pancreatitis

• history of surgery

• liver disease

• long QT syndrome

• low magnesium or potassium levels in the body

• total gastrectomy

• an unusual or allergic reaction to nilotinib, lactose, gelatin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

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. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

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.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

Height and weight growth of a child taking this medicine will be monitored closely.

Do not become pregnant while taking this medicine or for at least 14 days after. 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 or for at least 14 days after the last dose.