Nilotinib Capsules

What is this medication?

NILOTINIB (nil OT i nib) treats leukemia. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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
• Having or recent surgery
• Heart disease
• History of pancreatitis
• Irregular heartbeat or rhythm
• Liver disease
• Low levels of magnesium or potassium in the blood
• Total gastrectomy
• An unusual or allergic reaction to nilotinib, lactose, gelatin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it on an empty stomach, at least 1 hour before or 2 hours after food. Do not cut, crush, or chew this medication. Swallow the capsules whole. You may open the capsule and put the contents in 1 teaspoon of applesauce. Swallow the medication and applesauce right away. Do not chew the medication or applesauce. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Take products with H2 blockers or antacids in them at a different time of day than this medication. Take H2 blockers 10 hours before or 2 hours after this medication. Take antacids 2 hours before or 2 hours after this medication.

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 care team about the use of this medication in children. While it may be prescribed for children as young as 1 year 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, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Flibanserin
• Fluconazole
• Lomitapide
• Pimozide
• Posaconazole
• Saquinavir
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Antacids
• Certain antibiotics, such as clarithromycin, erythromycin, telithromycin, troleandomycin
• Certain antivirals for HIV or AIDS
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for depression, anxiety, or other mental health conditions
• Certain medications for fungal infections, such as ketoconazole, itraconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole
• Dexamethasone
• Dofetilide
• Grapefruit juice
• Medications that help you fall asleep
• Mifepristone
• Other medications that cause heart rhythm changes
• 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 care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work while taking this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

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

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 14 days after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 14 days after the last dose. Talk to your care team about reliable forms of contraception.

Do not breast-feed while taking this medication 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Burning, pain, tingling, or color changes in the hands, arms, legs, or feet
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High potassium level—muscle weakness, fast or irregular heartbeat
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Shortness of breath or trouble breathing
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden weight gain
• Swelling of the ankles, hands, or feet
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

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

• Constipation
• Cough
• Diarrhea
• Fatigue
• Headache
• Joint pain
• Nausea

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 medication after the expiration date.

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication 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.