Calendar
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 three remaining workshops
being offered this year:
September 17, 2015 (prior to ASH Meeting on
Hematologic Malignancies)
Chicago, IL
ASH Meeting on Hematologic Malignancies
2015 European Cancer Congress
October 9, 2015
New York, NY
At the inaugural ASH Meeting on Hematologic Malignancies experts will discuss the latest developments in
clinical care and evidence-based treatment approaches
in core malignancies.
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.
October 16, 2015
Tampa, FL
September 17–19, 2015
Chicago, IL
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 Prolongation
Tasigna has been shown to prolong cardiac ventricular repolarization as
measured by the QT interval on the surface ECG in a concentrationdependent manner [see Adverse Reactions (6.1), Clinical Pharmacology
(12.6) in the full prescribing information]. Prolongation of the B