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:

• Alcohol use
• Bleeding problems
• Blood circulation problems
• Have had a stroke
• Have had pancreatitis
• Heart disease
• Heart failure
• High or low levels of electrolytes, such as magnesium or potassium, in your blood
• Irregular heartbeat or rhythm
• Liver disease
• Slow heartbeat
• Surgery to remove your stomach
• An unusual or allergic reaction to nilotinib, lactose, gelatin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

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 2 hours before or 1 hour 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. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication with grapefruit juice.

Take acid reducers called H2 blockers and antacids 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
• Live virus vaccines
• Lomitapide
• Lonafarnib
• Pimozide
• Posaconazole
• Saquinavir
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Antacids
• Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole
• Grapefruit juice
• Other medications that cause heart rhythm changes
• St. John's wort

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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. Report any side effects. Continue your course of treatment even if you have side effects unless your care team tells you to stop.

You may need blood work done before or while taking this medication. Your care team may also give you a test called an electrocardiogram (ECG) to check your heart before and during treatment.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or 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 medication.

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 their growth.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 14 days after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 14 days after the last dose. Your care team can help find the option that works for you.

Do not breastfeed 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
• 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
• Swelling of the ankles, hands, or feet, shortness of breath or trouble breathing, sudden weight gain
• 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 these 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 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, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another 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.