Nilotinib Oral Capsule

What is this medication?

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).

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

COMMON BRAND NAME(S): Tasigna

What should I tell my care team before I take this medication?

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

How should I use this medication?

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.

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 medication?

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

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 medication?

Visit your health care provider for regular check ups on your progress. It may be some time before you see the benefit from this medicine.

You may need blood work done while you are taking this medicine.

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

This medicine may slow your child's growth if it is taken for a long time at high doses. Your health care provider will monitor your child's growth.

Do not become pregnant while taking this medicine or for 14 days after stopping it. Women should inform their health care provider 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 provider for more information. Do not breast-feed an infant while taking this medicine and for 14 days after the last dose.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• bleeding (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 eyes, gums, or nose)
• chest pain
• edema (sudden weight gain; swelling of the ankles, feet, hands or other unusual swelling; trouble breathing)
• heartbeat rhythm changes (chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• infection (fever, chills, cough, sore throat, pain or difficulty passing urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; yellowing of the eye or skin)
• pancreatitis (stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting)
• slow growth in children (if used for long periods of time)
• sudden numbness or weakness of the face, arm or leg
• trouble speaking or understanding
• trouble walking
• unusually weak or tired

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
• nausea
• vomiting

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.