Literature Scan
Continued from page 62
fewer risk factors for thrombosis
and recurrent thrombosis in the
CATCH population. “Further studies are needed to assess whether
the efficacy outcomes would be
different in patients at higher risk of
recurrent VTE,” they noted.
The lower-than-expected
incidence of recurrent VTE led Dr.
Lee and co-authors to identify small
sample size as one of the limitations
of the CATCH trial. Other limitations included the study’s open-label
design (as a source of potential bias),
the 5 percent of patients who withdrew consent or were lost to followup, and that the CATCH study was
not designed to address potential
differences in relative efficacy and
safety of tinzaparin versus warfarin
in subgroups among patients with
different types of cancer.
Overall, tinzaparin did not
outperform warfarin in terms of
efficacy or safety (except for reduction in the risk of clinically relevant
non-major bleeding), the authors
concluded. They added, however,
that “the significant reduction in
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