Nilotinib

Indications and Usage

Nilotinib is FDA approved for the treatment of

• Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
• Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
• Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.

Side effects needing medical attention

Eligible newly diagnosed patients with Ph+ CML-Chronic Phase who have received nilotinib for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) and patients with Ph+ CML-Chronic Phase resistant or intolerant to imatinib who have received nilotinib for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation.

 

Side effects needing medical attention

Irregularity in heartbeat; fainting; unexplained bleeding or bruising; blood in urine or stool; unexplained weakness; yellow skin and eyes; shortness of breath; swelling of hands, ankles, feet, or face; sudden stomach area pain with nausea and vomiting; low blood count; rash; nausea; headache; itching; tiredness; diarrhea; constipation.