Nilotinib is inhibitor of the Bcr-Abl kinase.

400 mg orally twice daily, approximately 12 hours apart and should not be taken with food.

Indicated for the treatment of chronic phase (CP) and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib.

The most commonly reported drug-related adverse reactions were rash, pruritis, nausea, fatigue, headache, constipation, diarrhea and vomiting. Serious reactions included thrombocytopenia, neutropenia and elevated lipase, hepatic and electrolyte abnormalities.

Sudden deaths have been reported in patients receiving nilotinib. It should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome.

CBC should be done every 2 weeks for the first 2 months, then monthly.

Hypokalemia or hypomagnesemia must be corrected prior to nilotinib administration and should be periodically monitored. Use with caution in patients with hepatic impairment.

ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments. Nilotinib prolongs the QT interval.

The capsules should be swallowed whole with water. No food should be consumed for at least 2 hours before the dose is taken and no food should be consumed for at least one hour after. Drug interactions: Avoid concomitant use of strong inhibitors or inducers of CYP3A4. If patients must be co-administered, a strong CYP3A4 inhibitor, dose reduction should be considered and the QT interval should be monitored closely.

Should not be used during pregnancy or breast-feeding. Sexually active female patients should use effective contraception during treatment.