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How it is administered
Nilotinib is taken by mouth as a capsule or tablet, usually twice daily, about 12 hours apart. It should be swallowed whole with water. For capsules, if you cannot swallow them, the contents may be mixed in a teaspoon of applesauce and taken immediately (within 15 minutes).
Nilotinib should be taken on an empty stomach—no food for at least 2 hours before and at least 1 hour after each dose. Do not consume grapefruit or grapefruit juice while taking nilotinib, as this can affect how the medication works.
Dosage for adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase is usually 300 mg twice daily. For those resistant or intolerant to prior therapy, the dose is typically 400 mg twice daily. Pediatric dosing is based on body surface area.
Always follow your doctor’s instructions for dosing and administration.
How it works
Nilotinib is a type of targeted cancer therapy known as a kinase inhibitor. It works by blocking the activity of a specific abnormal protein called BCR-ABL, which is produced by cancer cells in certain blood cancers, such as chronic myeloid leukemia (CML). This abnormal protein causes cancer cells to grow and multiply uncontrollably.
By inhibiting BCR-ABL and related kinases, nilotinib helps to stop the growth and spread of cancer cells. It binds to the inactive form of the kinase, preventing it from sending signals that tell the cancer cells to grow. Nilotinib is particularly effective in patients whose cancer cells have developed resistance to other treatments, such as imatinib, because it can block many of the mutations that make the cancer resistant.
Nilotinib is not a chemotherapy drug in the traditional sense; instead, it is a targeted therapy that specifically interferes with molecular pathways involved in cancer cell survival and proliferation. This targeted approach helps to limit the effects on normal, healthy cells.
Common side effects
Common side effects of nilotinib include:
- Nausea
- Rash
- Headache
- Fatigue
- Itching (pruritus)
- Vomiting
- Diarrhea
- Cough
- Constipation
- Joint pain (arthralgia)
- Fever (pyrexia)
- Night sweats
- Low platelet count (thrombocytopenia)
- Low white blood cell count (neutropenia)
- Anemia
- Fluid retention
- Elevated liver enzymes
- High blood sugar
- QT prolongation (heart rhythm changes)
Who Should take it
Nilotinib is approved for adults and children (aged 1 year and older) with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. It is also used for adults and children with chronic phase or accelerated phase Ph+ CML who are resistant to or cannot tolerate prior therapy, including imatinib.
Nilotinib is not specifically indicated for lymphoblastic lymphoma, but it may be used in certain cases of blood cancers where the BCR-ABL abnormality is present. Your doctor will determine if nilotinib is appropriate for your specific diagnosis based on your disease type, genetic markers, and previous treatments.
It is important to have regular follow-up and monitoring while taking nilotinib to ensure it is working and to manage any side effects.
Who should not take it
Nilotinib should not be taken by patients who have low levels of potassium or magnesium in their blood or by those with a condition called long QT syndrome, which affects the heart’s electrical activity and can cause dangerous irregular heartbeats.
If you have a history of heart problems, liver problems, pancreatitis, or have had a total gastrectomy (removal of the stomach), you should inform your doctor before starting nilotinib. Pregnant women should not take nilotinib, as it can harm the unborn baby. Women who are breastfeeding should also avoid nilotinib.
Nilotinib is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption, as the capsules contain lactose.
Commonly used with
Nilotinib may be used in combination with supportive medications such as hematopoietic growth factors (for example, erythropoietin or G-CSF) if clinically indicated. It can also be used with hydroxyurea or anagrelide to help control blood counts.
It is important to avoid using nilotinib with certain other medications that can interact and increase the risk of side effects, especially drugs that affect heart rhythm or are metabolized by the same liver enzymes (CYP3A4). Always inform your healthcare provider about all medications and supplements you are taking.
Commonly tested with
Nilotinib has been studied and compared with other tyrosine kinase inhibitors, such as imatinib, in clinical trials for chronic myeloid leukemia. It is also tested in combination with other supportive therapies like hydroxyurea or growth factors.
In clinical practice, nilotinib is not usually combined with other cancer drugs for CML, but it may be tested in research settings with other targeted therapies or supportive medications to improve outcomes or manage side effects.
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