Brand Tasigna

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 taking antacids or acid blockers (such as cimetidine), take nilotinib 2 to 3 hours before or after these medicines. The dosage is based on your medical condition, response to treatment, and certain other drugs you may be taking. Your doctor will order blood tests to adjust the dose. 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.

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. Nilotinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using nilotinib, tell your doctor or pharmacist 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 that you are taking this medication. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections. To lower your risk 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 is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately. 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 is not recommended. Consult your doctor before breast-feeding.

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. Many other drugs interact with nilotinib. Some examples are certain HIV medications, antibiotics, antifungals, and medications to treat seizures. Drug interactions may increase serious side effects or cause your medications to stop working properly. Your doctor or pharmacist should check for interactions and may need to adjust your treatment. Therefore, before using nilotinib, tell your doctor and pharmacist of all prescription and nonprescription/herbal products you may use. 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. Therefore, before using nilotinib, report all medications you are currently using to your doctor or pharmacist. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: warfarin. Check the labels on all your nonprescription/herbal medications. They may contain medications that can interact with nilotinib (e.g., the acid blocker cimetidine, proton pump inhibitors (such as omeprazole), herbal products to lower cholesterol, St. John's wort). Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, 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 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. Many people using this medication 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. Tell your doctor immediately if any of these very serious side effects occur: easy bleeding/bruising, bloody/black stool, signs of infection (e.g., fever, chills, persistent sore throat). Seek immediate medical attention if any of these rare but serious side effects occur: fast/pounding/irregular heartbeat, severe dizziness, fainting, shortness of breath. Tell your doctor immediately if any of these rare but very serious side effects occur: confusion, severe abdominal/stomach pain, persistent nausea/vomiting, seizures, unusual tiredness, toe/joint pain, painful urination, change in the amount of urine, bloody/pink urine, dark urine, vision changes, yellowing skin/eyes. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.