ASH Clinical News February 2016 | Page 21

FOR THE TREATMENT OF ADULTS WITH NEWLY DIAGNOSED Ph+ CML-CP AND ADULTS WITH RESISTANT OR INTOLERANT Ph+ CML-CP/AP TAKE ON Ph+ CML Help patients reach their treatment goals with TASIGNA® (nilotinib) ‘‘ I relied on the skyhook. ‘‘ InIn basketball, treating my Ph+ CML, I rely on TASIGNA. - KAREEM ABDUL-JABBAR NBA LEGEND Kareem Abdul-Jabbar is an actual Ph+ CML patient taking TASIGNA and is compensated by Novartis. 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. Please see additional Important Safety Information and brief summary of Prescribing Information, including Boxed WARNING, on the following pages.