First- and Second-Line Nilotinib in CML

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Nilotinib was initially approved as a second-line therapy for patients with chronic myelogenous leukemia (CML) in October 2007. In this setting, nilotinib is administered at 400 mg twice daily. In June 2010, nilotinib at 300 mg twice daily was approved for newly diagnosed patients with CML. In this setting, nilotinib demonstrated a major molecular response rate of 77% compared with 60% with imatinib.

When administering nilotinib, there are several key factors that need to be considered, explains B. Douglas Smith, MD. The first- and second- line doses for nilotinib are different, which requires adjustment. Additionally, unique side effects are associated with nilotinib, which can be utilized to tailor treatment selection, Smith suggests.

Nilotinib should be taken on an empty stomach, to avoid side effects associated with absorption, Smith warns. Patients should avoid food two hours before and one hour after taking the drug. This window without food consumption makes treatment with nilotinib challenging for patients with type 2 diabetes mellitus or poor blood sugar control, notes Smith.

Nilotinib is associated with prolongation in QT intervals, as is indicated in a Boxed Warning. To monitor this, an ECG should be performed to monitor the QTc at baseline, seven days after the initiation of treatment, following dose adjustments, and at intervals throughout therapy. Additionally, nilotinib should not be used in patients with hypokalemia, hypomagnesaemia, or long QT syndrome.