FULLY FDA APPROVED
AR TE
YEPDA
WE’RE
5U
FOR THE TREATMENT OF ADULTS WITH NEWLY DIAGNOSED Ph+ CML-CP
THAT
CLOSE
99%
of TASIGNA® (nilotinib) patients
did not progress to AP/BC at 5 years1*
In ENESTnd, 95% of imatinib patients did not progress to AP/BC at 5 years1*
INDICATIONS
• TASIGNA® (nilotinib) is indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome–positive chronic myeloid leukemia
(Ph+ CML) in chronic phase. The effectiveness of TASIGNA is based on major molecular response and cytogenetic response rates
• TASIGNA is indicated for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant to or intolerant to prior therapy that
included imatinib. The effectiveness of TASIGNA is based on hematologic and cytogenetic response rates
WARNING: QT PROLONGATION AND SUDDEN DEATHS
• TASIGNA prolongs the QT interval. Prior to TASIGNA administration and periodically, monitor for hypokalemia or hypomagnesemia and correct
deficiencies. Obtain ECGs to monitor the QTc at baseline, 7 days after initiation, and periodically thereafter, and following any dose adjustments
• Sudden deaths have been reported in patients receiving nilotinib. Do not administer TASIGNA to patients with hypokalemia, hypomagnesemia,
or long QT syndrome
• Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors
• Avoid food 2 hours before and 1 hour after taking dose
IMPORTANT SAFETY CONSIDERATIONS
• Myelosuppression: Treatment with TASIGNA can cause Grade 3/4 thrombocytopenia, neutropenia, and anemia. Complete blood counts should be performed every
2 weeks for the first 2 months and then monthly thereafter
• Cardiac and Arterial Vascular Occlusive Events: Cases of cardiovascular events included ischemic heart disease-related events, peripheral arterial occlusive
disease, and ischemic cerebrovascular events have been reported
• Pancreatitis and Elevated Serum Lipase: TASIGNA can cause increases in serum lipase. Caution is recommended in patients with a history of pancreatitis
• Hepatotoxicity: The use of TASIGNA may result in elevations in bilirubin, AST/ALT, and alkaline phosphatase
Ph+ CML, Philadelphia chromosome–positive chronic myeloid leukemia; CP, chronic phase; AP, accelerated phase; BC, b