Consumer Drug Information

Tasigna

Generic Name: Nilotinib Capsules (NYE-lo-ti-nib)
Brand Name: Tasigna

Tasigna may cause serious and sometimes fatal irregular heartbeat (eg, QT prolongation). Tell your doctor if you have a history of QT prolongation, low blood potassium or magnesium levels, or heart or liver problems. Certain medicines may increase the risk of irregular heartbeat. Tell your doctor about any other medicines or supplements you take. Tell your doctor or seek medical care at once if irregular heartbeat or fainting occurs.

Lab tests, including liver function, electrocardiogram (ECG), and blood electrolyte levels, may be performed before and during treatment. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Take Tasigna on an empty stomach at least 1 hour before or 2 hours after you eat.

Tasigna is used for:

Treating certain types of leukemia (eg, chronic myelogenous leukemia). It may also be used for other conditions as determined by your doctor.

Tasigna is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Tasigna if:

you are allergic to any ingredient in Tasigna
you have a history of QT prolongation
you have low blood potassium or magnesium levels
you have galactose intolerance, severe lactase deficiency, or glucose-galactose absorption problems
you are taking an antiarrhythmic (eg, amiodarone, dofetilide, procainamide), arsenic, astemizole, cisapride, methadone, perflutren, certain quinolones (eg, levofloxacin), or terfenadine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tasigna :

Some medical conditions may interact with Tasigna . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you are lactose intolerant
if a member of your family has a history of QT prolongation
if you have a history of heart problems (eg, irregular heartbeat), liver or kidney problems, pancreas problems, or abnormal blood electrolyte (eg, phosphate, calcium, sodium) levels
if you have bone marrow problems, low white blood cell levels, low blood platelet levels, or anemia
if you also have another type of cancer

Some MEDICINES MAY INTERACT with Tasigna . Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Tasigna
Antiarrhythmics (eg, amiodarone, dofetilide, procainamide), arsenic, astemizole, azole antifungals (eg, itraconazole, ketoconazole), cisapride, delavirdine, HIV protease inhibitors (eg, atazanavir, ritonavir), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, clarithromycin, erythromycin), methadone, nefazodone, perflutren, quinolones (eg, levofloxacin), terfenadine, or trazodone because they may increase the risk of Tasigna 's side effects, including severe irregular heartbeat
Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, dexamethasone), hydantoins (eg, phenytoin), rifabutin, rifapentin, rifampin, or St. John's wort because they may decrease Tasigna 's effectiveness
Midazolam because the risk of its side effects may be increased by Tasigna

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tasigna may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tasigna :

Use Tasigna as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tasigna comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tasigna refilled.
Take Tasigna by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Swallow Tasigna whole. Do not break, crush, or chew before swallowing.
Take Tasigna with a full glass of water.
Do not eat grapefruit or drink grapefruit juice while you use Tasigna .
Take Tasigna on a regular schedule about 12 hours apart, unless your doctor tells you otherwise.
Continue to take Tasigna even if you feel well. Do not miss any doses.
If you miss a dose of Tasigna , skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tasigna .

Important safety information:

Tasigna may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tasigna with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do NOT take more than the recommended dose or stop taking Tasigna without checking with your doctor.
Tell your doctor or dentist that you take Tasigna before you receive any medical or dental care, emergency care, or surgery.
Tasigna may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
Tasigna may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Tasigna . Talk with your doctor before you receive any vaccine.
If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
If you may become pregnant, you must use an effective form of birth control while you take Tasigna . If you have questions about effective birth control, talk with your doctor.
Lab tests, including ECG, liver function, blood electrolyte levels, and complete blood cell counts, may be performed while you use Tasigna . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Tasigna should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Tasigna may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tasigna while you are pregnant. It is not known if Tasigna is found in breast milk. Do not breast-feed while taking Tasigna .

Possible side effects of Tasigna :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone, joint, or muscle aches; constipation; diarrhea; dizziness; flushing; gas; hair loss; headache; loss of appetite; mild itching; mild muscle cramps; nausea; stomach pain or upset; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; blood in the urine; change in the amount of urine produced; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever or chills; mental or mood changes (eg, anxiety, depression); numbness, tingling, or weakness of an arm or leg; seizure; severe or persistent cough or sore throat; severe or persistent headache, tiredness, or weakness; severe or persistent muscle pain or cramps; severe stomach pain, nausea, or vomiting; shortness of breath; slurred speech; sudden unusual weight gain; swelling of the hands, feet, ankles, or around the eyes; unusual bruising or bleeding; vision changes; vomit that looks like coffee grounds; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Tasigna :

Store Tasigna at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tasigna out of the reach of children and away from pets.

General information:

If you have any questions about Tasigna , please talk with your doctor, pharmacist, or other health care provider.
Tasigna is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tasigna . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: December 3, 2008

Database Edition 08.4.1.003