Prolongation of the QT interval and sudden death have been reported. Do not use nilotinib in the presence of hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to nilotinib administration and monitored during treatment. Avoid drugs that prolong the QT interval and strong CYP3A4 inhibitors. Avoid food 2 hours before and one hour after taking nilotinib. A dose reduction is recommended in patients with hepatic impairment. ECGs should be obtained to monitor the QTc .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Tyrosine Kinase Inhibitor
Nilotinib belongs to the group of medicines called antineoplastics. It is used to treat a type of cancer called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) after other treatments, such as imatinib (Gleevec®), have failed. CML is a disease where your body makes too many abnormal white blood cells. This can cause you to become sick more often and to feel weak or tired. Nilotinib helps your body stop making these abnormal white blood cells.
Nilotinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, 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 good nilotinib will do as well as the possible risks of using it.
nilotinib is available only with your doctor's prescription.
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 nilotinib, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to nilotinib 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 the pediatric population. 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.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
Using nilotinib 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.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using nilotinib 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 nilotinib, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of nilotinib. Make sure you tell your doctor if you have any other medical problems, especially:
Take nilotinib 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 nilotinib without checking first with your doctor.
nilotinib should come with a medication guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
It is best to take nilotinib on an empty stomach (at least 1 hour before or 2 hours after a meal).
Swallow the capsule whole with water. Do not open the capsule. If you have trouble swallowing the capsule, tell your doctor.
The dose of nilotinib 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 nilotinib. 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 nilotinib, take it as soon as possible. However, if it is almost time for your next dose, 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.
It is very important that your doctor check your progress at regular visits to make sure that nilotinib is working properly. Blood tests may be needed to check for unwanted effects.
nilotinib can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Check with your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
Using nilotinib while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Nilotinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Do not eat grapefruit or drink grapefruit juice while you are using nilotinib. Grapefruit and grapefruit juice may change the amount of nilotinib that is absorbed in the body.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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