Generic Name: nilotinib (nye-LOE-ti-nib)
Brand Name: Tasigna
Nilotinib may cause serious and sometimes fatal irregular heartbeat (eg, QT prolongation). Sudden deaths have been reported in patients taking nilotinib. It is thought that serious irregular heartbeat may have contributed to these sudden deaths. Do not take nilotinib if you have low blood potassium or magnesium levels, or a history of QT prolongation. Tell your doctor if you have a history of 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. Your doctor may change or lower your dose of nilotinib if you have liver problems.
Lab tests, including blood electrolyte levels, complete blood cell counts, pancreas function, liver function, and electrocardiograms (ECGs), 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 nilotinib on an empty stomach at least 1 hour before or 2 hours after eating.
Nilotinib 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.
Nilotinib is a kinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use nilotinib if:
- you are allergic to any ingredient in nilotinib
- you have a certain type of irregular heartbeat (QT prolongation, long QT syndrome)
- you have low blood potassium or magnesium levels
- you have galactose intolerance, severe lactase deficiency, glucose-galactose absorption problems, or severe lactose intolerance
- you are taking an antiarrhythmic (eg, amiodarone, dofetilide, procainamide), arsenic, astemizole, a certain azole antifungal (eg, ketoconazole, itraconazole, voriconazole), a barbiturate (eg, phenobarbital), bepridil, carbamazepine, chloroquine, cisapride, citalopram, clozapine, delavirdine, dexamethasone, dolasetron, domperidone, droperidol, halofantrine, haloperidol, a hydantoin (eg, phenytoin), iloperidone, a ketolide (eg, telithromycin), another kinase inhibitor (eg, vandetanib), a macrolide antibiotic (eg, clarithromycin), maprotiline, methadone, nefazodone, ondansetron, paliperidone, pentamidine, a phenothiazine (eg, chlorpromazine), pimozide, a protease inhibitor (eg, atazanavir, boceprevir, ritonavir), quetiapine, a quinolone (eg, moxifloxacin), a rifamycin (eg, rifampin), romidepsin, St. John's wort, tacrolimus, terfenadine, tetrabenazine, toremifene, trazodone, a tricyclic antidepressant (eg, imipramine), or ziprasidone
Contact your doctor or health care provider right away if any of these apply to you.
Before using nilotinib:
Some medical conditions may interact with nilotinib. 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, congestive heart failure, irregular or slow heartbeat), a heart attack, liver or kidney problems, pancreas problems (eg, pancreatitis), 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 or you have had all of your stomach removed (total gastrectomy)
Some MEDICINES MAY INTERACT with nilotinib. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antiarrhythmics (eg, amiodarone, dofetilide, procainamide), arsenic, astemizole, azole antifungals (eg, ketoconazole, itraconazole, voriconazole), bepridil, chloroquine, cisapride, citalopram, clozapine, delavirdine, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, ketolides (eg, telithromycin), other kinase inhibitors (eg, vandetanib), macrolide antibiotics (eg, clarithromycin), maprotiline, methadone, nefazodone, ondansetron, paliperidone, pentamidine, phenothiazines (eg, chlorpromazine), pimozide, protease inhibitors (eg, atazanavir, boceprevir, ritonavir), quetiapine, quinolones (eg, moxifloxacin), romidepsin, tacrolimus, terfenadine, tetrabenazine, toremifene, trazodone, tricyclic antidepressants (eg, imipramine), or ziprasidone because the risk of severe and possibly fatal irregular heartbeat may be increased
- Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), nevirapine, proton pump inhibitors (PPIs) (eg, omeprazole), rifamycins (eg, rifampin), or St. John's wort because they may decrease nilotinib's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if nilotinib 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 nilotinib:
Use nilotinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Nilotinib comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get nilotinib refilled.
- Take nilotinib by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
- Swallow nilotinib whole with a full glass of water. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a teaspoon of applesauce. Mix the medicine with the applesauce and swallow the mixture right away (within 15 minutes), followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
- Do not eat grapefruit or drink grapefruit juice while you use nilotinib.
- Take nilotinib on a regular schedule about 12 hours apart, unless your doctor tells you otherwise.
- If you take an H2 receptor antagonist (eg, ranitidine) or an antacid, talk with your doctor or pharmacist about how to take these medicines together.
- Check with your doctor to see if you should drink extra fluids while you are taking nilotinib.
- Continue to take nilotinib even if you feel well. Do not miss any doses.
- If you miss a dose of nilotinib, 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 nilotinib.
Important safety information:
- Nilotinib may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use nilotinib 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, change your dose, or stop taking nilotinib without checking with your doctor.
- Tell your doctor or dentist that you take nilotinib before you receive any medical or dental care, emergency care, or surgery.
- Nilotinib 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.
- Nilotinib 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.
- A serious and possibly fatal condition called tumor lysis syndrome (TLS) has been reported in certain patients taking nilotinib. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking nilotinib. 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.
- Women who may become pregnant must use an effective form of birth control while taking nilotinib. If you have questions about effective birth control, talk with your doctor.
- Lab tests, including ECG, liver function, pancreas function, blood cholesterol, blood electrolyte levels, and complete blood cell counts, may be performed while you use nilotinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Nilotinib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Nilotinib may cause harm to the fetus. Do not become pregnant while you are taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking nilotinib while you are pregnant. It is not known if nilotinib is found in breast milk. Do not breast-feed while taking nilotinib.
Possible side effects of nilotinib:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; bone, joint, or muscle aches; constipation; diarrhea; dizziness; dry skin; flushing; gas; hair loss; headache; loss of appetite; mild itching; mild muscle cramps or spasms; mild stomach pain or upset; nausea; night sweats; runny or stuffy nose; sneezing; tiredness; trouble sleeping; vomiting; weakness.
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; burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; dark urine; fainting; fast, slow, or irregular heartbeat; fever or chills; light-headedness; mental or mood changes (eg, anxiety, depression); numbness or weakness of an arm or leg; one-sided weakness; pale stools; seizure; severe or persistent cough or sore throat; severe or persistent dizziness, headache, tiredness, or weakness; severe or persistent muscle pain, weakness, or cramps; severe or persistent stomach pain, loss of appetite, 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fever, chills, or sore throat; severe drowsiness or vomiting.Proper storage of nilotinib:
Store nilotinib 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 nilotinib out of the reach of children and away from pets.
- If you have any questions about nilotinib, please talk with your doctor, pharmacist, or other health care provider.
- Nilotinib 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take nilotinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about nilotinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to nilotinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using nilotinib.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.