How it is administered

Nilotinib is taken by mouth as a capsule or tablet, usually twice a day, about 12 hours apart. It should be swallowed whole with water. For the capsule form, if you cannot swallow the capsule, you may open it and mix the contents with one teaspoon of applesauce and take it immediately (within 15 minutes).

For the capsule, take nilotinib on an empty stomach: do not eat for at least 2 hours before and 1 hour after taking each dose. For the tablet (Danziten), it can be taken with or without food. Always follow your healthcare provider's instructions and the specific product directions.

How it works

Nilotinib is a type of targeted therapy known as a tyrosine kinase inhibitor (TKI). It works by blocking the activity of a specific abnormal protein called BCR-ABL, which is produced by leukemia cells in people with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). This abnormal protein causes the leukemia cells to grow and divide uncontrollably.

By inhibiting BCR-ABL, nilotinib helps to slow or stop the growth of these cancer cells and can even lead to their death. Nilotinib is effective in patients who are newly diagnosed as well as those who have not responded to or cannot tolerate other treatments like imatinib. It is also able to overcome certain mutations that make CML resistant to other TKIs. This targeted action means nilotinib specifically attacks cancer cells while having less effect on normal, healthy cells.

Who Should take it

Nilotinib is prescribed for adults and children (age 1 year and older) with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase, especially:

• Patients who are newly diagnosed with Ph+ CML in the chronic phase.
• Patients with chronic phase or accelerated phase Ph+ CML who are resistant to or cannot tolerate prior therapy, including imatinib.
• Pediatric patients (age 1 year and older) with Ph+ CML in the chronic or accelerated phase who are resistant or intolerant to prior tyrosine kinase inhibitor therapy.

Nilotinib is also considered for patients who have achieved a deep and sustained molecular response and may be eligible for treatment discontinuation under close monitoring (treatment-free remission).

Who should not take it

Nilotinib should not be taken by:

• Patients with low levels of potassium (hypokalemia) or magnesium (hypomagnesemia) in their blood.
• Patients with a history or presence of long QT syndrome (a heart rhythm condition that can cause serious irregular heartbeats).
• Patients who are allergic to nilotinib or any of its ingredients.

It should be used with caution in people with significant heart problems, liver problems, pancreatitis, or those who are pregnant or breastfeeding. Always inform your doctor about your full medical history and all medications you are taking before starting nilotinib.

Commonly used with

Nilotinib may be used in combination with supportive medications such as:

• Hematopoietic growth factors (like erythropoietin or G-CSF) if needed for blood cell support.
• Hydroxyurea or anagrelide may be used alongside nilotinib in certain cases for blood count control.

It is not typically combined with other cancer therapies for CML, but always follow your doctor’s advice regarding any additional medications.

Commonly tested with

Nilotinib has been studied in combination or compared with:

• Imatinib (another TKI) in clinical trials for newly diagnosed CML.
• Other supportive medications such as hydroxyurea and anagrelide.

It is also tested with medications that may interact with its metabolism, such as CYP3A4 inhibitors (like ketoconazole) or inducers (like rifampicin), and with drugs that can affect heart rhythm. Your doctor will monitor for potential drug interactions and may adjust your treatment plan accordingly.