ASH Clinical News September 2015 | Page 10

Calendar 2015 European Cancer Congress September 25 – 29, 2015 Vienna, Austria The European Cancer Congress (ECC 2015) is a biennial congress that combines the efforts of the most important European oncology professionals with the aim of improving the prevention, diagnosis, treatment, and care of cancer patients. Improving MDS Outcomes from Diagnosis to Treatment: A Multidisciplinary Approach Co-hosted by ASH, the American Society for Clinical Pathology, and the France Foundation, these complimentary CME summits on MDS are designed with the goal of improving performance diagnosis and treatment of MDS patients. There are two remaining workshops being offered this year: American Society for Radiation Oncology Annual Meeting The 53rd Annual Meeting of the Japan Society of Clinical Oncology This year, ASTRO invites more than 11,000 attendees to its 57th Annual Meeting to discuss the theme of “Technology Meets Patient Care.” Japan’s largest multidisciplinary academic society of clinical oncology will hold its annual meeting as an open discussion of the latest advances in current cancer treatment. October 18 – 21, 2015 San Antonio, TX October 24 – 26, 2015 Kyoto, Japan October 9, 2015 New York, NY October 16, 2015 Tampa, FL TASIGNA® (nilotinib) Capsules for oral use Initial U.S. Approval: 2007 BRIEF SUMMARY: Please see package insert for full prescribing information. 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 (5.2). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments (5.2, 5.3, 5.7, 5.15). • Sudden deaths have been reported in patients receiving nilotinib (5.3). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (4, 5.2). • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors (5.8). • Avoid food 2 hours before and 1 hour after taking the dose (5.9). 1 INDICATIONS AND USAGE 1.1 Newly Diagnosed Ph+ CML-CP Tasigna (nilotinib) is indicated for the treatment of adult patients with newly diagnosed 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 [see Clinical Studies (14.1) in the full prescribing information]. 1.2 Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates [see Clinical Studies (14.2) in the full prescribing information]. 4 CONTRAINDICATIONS Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning]. 5 WARNINGS AND PRECAUTIONS 5.1 Myelosuppression Treatment with Tasigna can cause Grade 3/4 thrombocytopenia, neutropenia and anemia. Perform complete blood counts every 2 weeks for the first 2 months and then monthly thereafter, or as clinically indicated. Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction [see Dosage and Administration (2.2) in the full prescribing information]. 5.2 QT Pro