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How it is administered
Nilotinib is taken by mouth as a capsule or tablet. It is usually taken twice daily, about 12 hours apart. For most patients, it should be taken on an empty stomach—no food should be eaten for at least 2 hours before and at least 1 hour after taking each dose. Swallow the capsules or tablets whole with water; do not open, crush, or chew them. If you cannot swallow capsules, the contents may be mixed in a teaspoon of applesauce and taken immediately (within 15 minutes).
For pediatric patients, the dose is based on body surface area and rounded to the nearest 50 mg (up to a maximum single dose of 400 mg).
How it works
Nilotinib is a type of targeted therapy known as a tyrosine kinase inhibitor. It works by blocking the activity of a specific protein called BCR-ABL, which is produced by cancer cells in certain types of leukemia, most notably Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). This protein causes the cancer cells to grow and multiply uncontrollably.
By inhibiting BCR-ABL and related kinases, nilotinib helps to stop the growth and spread of these cancer cells. It is especially effective in patients whose leukemia is resistant to or intolerant of prior therapies, such as imatinib. Nilotinib can also overcome some mutations that make leukemia cells resistant to other treatments. This targeted approach helps to control the disease and can lead to remission in many patients.
Common side effects
Common side effects of nilotinib include:
- Nausea
- Rash
- Headache
- Fatigue
- Itching (pruritus)
- Vomiting
- Diarrhea
- Cough
- Constipation
- Joint pain (arthralgia)
- Runny or stuffy nose (nasopharyngitis)
- Fever (pyrexia)
- Night sweats
Who Should take it
Nilotinib is approved for adults and children (aged 1 year and older) with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, both newly diagnosed and those who are resistant or intolerant to previous therapies, including imatinib.
It is also indicated for adults with accelerated phase Ph+ CML who are resistant or intolerant to prior therapy. Nilotinib may be used as a long-term treatment and, in some cases, patients who achieve a sustained deep molecular response may be eligible to discontinue therapy under close medical supervision (treatment-free remission).
Who should not take it
Nilotinib should not be taken by patients who have low levels of potassium or magnesium in their blood (hypokalemia or hypomagnesemia) or those with a condition called long QT syndrome, which affects the heart's electrical activity and can cause dangerous irregular heartbeats.
It is also not recommended for patients with severe lactose intolerance or certain rare hereditary problems of sugar metabolism, as the capsules contain lactose. Pregnant women should avoid nilotinib due to the risk of harm to the unborn baby. Always inform your healthcare provider about all your medical conditions and medications before starting nilotinib.
Commonly used with
Nilotinib may be used with supportive medications such as hematopoietic growth factors (like erythropoietin or G-CSF) to help manage low blood counts. It can also be used with hydroxyurea or anagrelide if clinically indicated to control blood cell counts.
Patients should avoid taking nilotinib with strong CYP3A4 inhibitors or inducers, as these can affect how the drug is metabolized. Always discuss all medications and supplements with your healthcare provider.
Commonly tested with
Nilotinib has been compared and tested with other tyrosine kinase inhibitors, especially imatinib, in clinical trials for chronic myeloid leukemia. It is also tested alongside supportive care agents like hydroxyurea, anagrelide, and hematopoietic growth factors.
In clinical studies, nilotinib has been evaluated for its effectiveness in patients who are resistant or intolerant to imatinib, and for its ability to achieve deep molecular responses that may allow for treatment discontinuation (treatment-free remission).
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