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Precautions and Warnings With Nilotinib

Specific Nilotinib Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Nilotinib may cause abnormally low blood cell counts, including low red blood cells, white blood cells, or platelets. This could increase your risk for anemia, infections, and bleeding problems. Your healthcare provider will monitor your blood counts with a simple blood test every two weeks for the first two months of treatment, and then monthly thereafter. If you develop low blood cell counts, your healthcare provider may need to temporarily stop treatment until the problem resolves.
  • This medication may cause a potentially life-threatening heart rhythm problem known as QT prolongation. Your healthcare provider will check your heart rhythm with an electrocardiogram (ECG) before you start treatment, seven days after you start, each time your dose is changed, and periodically throughout treatment.

People who take nilotinib with food and who take certain other medicines may have an increased risk for QT prolongation. Therefore, take this medicine on an empty stomach, and talk to your healthcare provider about all the medicines you are taking (see Drug Interactions With Nilotinib).

  • You should know that there have been rare reports of sudden death in people taking nilotinib.
  • Nilotinib may increase the risk for pancreatitis, which is inflammation of the pancreas (the gland behind the stomach that releases enzymes to help the body digest food and hormones to help the body process sugars). Your healthcare provider will take blood tests each month to check for high levels of pancreatic enzymes.

Contact your healthcare provider right away if you experience sudden abdominal (stomach) pain with nausea and vomiting, as these may be signs of pancreatitis.

  • Your healthcare provider will check your liver function, using blood tests, at least monthly during treatment to monitor you for potential liver problems from nilotinib. People who already have liver disease before starting treatment will be started on a lower nilotinib dose.
  • This medicine may cause electrolyte problems (high or low blood salts, such as potassium, sodium, calcium, and phosphate). Before you being treatment with nilotinib, your healthcare provider will check your electrolytes with a blood test, and correct any abnormalities. You will also need periodic monitoring of electrolytes during treatment.
  • Taking this medicine with food may cause your body to absorb too much of the drug, which could increase your risk for potentially serious nilotinib side effects. This medication should be taken on an empty stomach. Do not eat for at least two hours before and one hour after taking your dose.
  • People who have had a medical procedure known as total gastrectomy (surgical removal of the stomach) may not be ideal candidates for nilotinib treatment because nilotinib blood levels may be lower in these people. If nilotinib is used, higher doses and close monitoring may be necessary.
  • Like many medications, nilotinib capsules contain lactose. This could be a problem in people with severe lactose intolerance. Mild lactose intolerance is not expected to cause a problem.
  • You will need routine blood tests and other monitoring while taking this medicine, to check for side effects and to make sure nilotinib is working for you. Be sure to keep all of your healthcare provider and laboratory appointments.
  • This medication has been reported to cause bleeding in the brain. Seek immediate medical attention if you develop symptoms such as confusion, vision changes, or a sudden severe headache.
  • Nilotinib is a pregnancy Category D medication, which means it may harm an unborn child. Talk to your healthcare provider about the risks and benefits of using this medication during pregnancy (see Tasigna and Pregnancy).
  • It is unknown whether nilotinib passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Tasigna and Breastfeeding).
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Nilotinib Drug Information

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