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Tasigna (Nilotinib Hydrochloride)
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
This drug can rarely cause serious (possibly fatal) irregular heartbeats (QT prolongation). Nilotinib should not be used in people with low blood levels of certain minerals (potassium, magnesium) or a certain heart problem (long QT syndrome). To lower your risk, your doctor will order certain blood tests (potassium/magnesium levels, liver function tests) before and during treatment with nilotinib. You should have a heart test (EKG) before starting nilotinib.
The EKG should be repeated 7 days after your first dose, when your dose is changed, and periodically while you are taking nilotinib. To decrease the risk of this effect, do not eat for 2 hours before or 1 hour after taking your dose. Other drugs/foods may increase the risk of an irregular heartbeat. Therefore, before taking this drug, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. See also How to Use and Drug Interactions sections.
Nilotinib is used to treat a certain type of blood cancer (chronic myelogenous leukemia-CML). It works by slowing or stopping the growth of cancer cells.
Read the Medication Guide provided by your pharmacist before you start using nilotinib and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details. Take this medication by mouth on an empty stomach, usually twice daily about 12 hours apart or as directed by your doctor.
Swallow the capsule whole with water. Do not open, break, or chew the capsules. Do not eat any food for at least 2 hours before or for 1 hour after taking your dose. Taking this medication with food can increase the amount of drug in your body and increase the risk of serious side effects. If unable to swallow the capsules, the capsules may be opened and the contents sprinkled in 1 teaspoon of applesauce. This mixture should be swallowed right away (within 15 minutes). Use only 1 teaspoon of applesauce.
Do not sprinkle the contents onto other types of food. Drink plenty of fluids during treatment with this medication, unless otherwise directed by your doctor. If you are also taking an antacid, take it 2 hours before or after nilotinib. If you are also taking an H2 blocker (such as cimetidine, famotidine), take it 10 hours before or 2 hours after nilotinib. The dosage is based on your medical condition, response to treatment, laboratory tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Children’s dosage is also based on body size. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the contents of the capsules.
See also Warning section. Nausea, vomiting, headache, tiredness, constipation, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body’s ability to fight an infection, or cause easy bruising/bleeding.
Tell your doctor right away if you develop any of the following serious symptoms: severe tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding (such as bloody/black stool, bloody/pink urine). Nilotinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, change in the amount of urine), muscle spasms/weakness.
Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, toe/joint pain, swelling hands/ankles/feet, unusual/rapid weight gain, symptoms of high blood sugar (such as increased thirst/urination), signs of liver disease (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine).
Get medical help right away if you have any very serious side effects, including: fast/pounding/irregular heartbeat, severe dizziness, fainting, seizures, signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), signs of bleeding in the brain (such as sudden severe headache, sudden vision changes, confusion, loss of consciousness), signs of blood circulation disease (such as numbness/pain in the legs, leg pain with physical activity, decrease in walking distance).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking nilotinib, tell your doctor or pharmacist if you are allergic to it; or to lactose/galactose; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, pancreatitis, heart disease (such as coronary artery disease, chest pain, heart attack), high blood pressure, high cholesterol, diabetes, stroke (including “mini-strokes” or transient ischemic attacks), blood circulation disease (peripheral arterial disease), blood vessel disease (hardening of the arteries/atherosclerosis), stomach surgery (such as gastrectomy).
Nilotinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using nilotinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using nilotinib safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Nilotinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection.
Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
This medication may affect a child’s bone growth and development. Consult the doctor or pharmacist for more details. Children may be more sensitive to the side effects of this drug, especially liver disease. Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nilotinib. Nilotinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 14 days after stopping treatment.
If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 14 days after stopping treatment is not recommended. Consult your doctor before breast-feeding.
See also How to Use. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Some products that may interact with this drug include: antacids, H2 blockers (such as cimetidine/famotidine), proton pump inhibitors (such as omeprazole).
Other medications can affect the removal of nilotinib from your body, which may affect how nilotinib works. Examples include azole antifungals (such as itraconazole, ketoconazole), HIV protease inhibitors (such as ritonavir), macrolide antibiotics (such as clarithromycin), rifamycins (such as rifabutin), St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. Many drugs besides nilotinib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others. Laboratory and/or medical tests (such as bone growth and development in children, complete blood count, EKG, electrolyte levels, liver function, lipase levels, uric acid level, cholesterol and blood sugar levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember, but do not take if it is less than 2 hours before or 1 hour after a meal. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
NILOTINIB – ORAL