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Nilotinib (oral route)

Available brands

Tasigna

About this medication

Nilotinib is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults and children who are newly diagnosed. It is also given to adults and children with Ph+ CML in chronic phase (CP) or accelerated phase (AP) who have taken other medicines (eg, imatinib, tyrosine-kinase inhibitor) but did not work well. Leukemia is a type of cancer where the body makes too many abnormal white blood cells. Nilotinib belongs to the general group of medicines known as antineoplastics or cancer medicines. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by nilotinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Before you begin treatment with nilotinib, you and your doctor should talk about the benefits this medicine will do as well as the possible risks of using it. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

Before using this medication

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of nilotinib in children younger than 1 year of age. Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nilotinib in the elderly. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

How to use this medication

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change the dose or stop using this medicine without checking first with your doctor. This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. It is best to take this medicine on an empty stomach (at least 1 hour before or 2 hours after a meal). Swallow the capsule whole with water. If you have trouble swallowing the capsule, open it and sprinkle the contents in one teaspoon of applesauce (puréed apple). Do not sprinkle Tasigna® on other foods. This mixture must be taken right away within 15 minutes and should not be stored for later use. If you are taking an H2 blocker medicine (eg, famotidine), take itat least 10 hours before or 2 hours afterusing nilotinib. If you are taking an antacid that contains aluminum, magnesium, or simethicone, take itat least 2 hours before or 2 hours afterusing nilotinib. Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of the medicine that is absorbed in the body. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

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