http://pharmaweblog.com/blog/2006/10/17/januvia-approved/ Pharmaceutical and biotech science and business Fri, 29 Aug 2008 23:23:27 +0000 http://wordpress.org/?v=2.0.2 http://pharmaweblog.com/blog/2006/10/17/januvia-approved/#comment-26 Tue, 17 Oct 2006 18:05:23 +0000 http://pharmaweblog.com/blog/2006/10/17/januvia-approved/#comment-26 Update on the label: I've read through the label. Januvia has a very clean clinical and preclinical toxicity profile based on labeling alone. Its drug interaction potential is low and no dosage reduction is required except in moderate to sever renal impairment. There were no clues in the label regarding investigations to rule out pleiotrophic activity at DDP-IV that might be subclinical in the studies reported in the label but could still be clinically meaningful in a larger, more diverse treatment population. Until such time as this information is made publicly available I advise caution before prescribing Januvia to those at particular risk of adverse effects due to mild suppression of T-cell immunity (i.e. those who are already immunosuppressed for whatever reason). Update on the label: I’ve read through the label. Januvia has a very clean clinical and preclinical toxicity profile based on labeling alone. Its drug interaction potential is low and no dosage reduction is required except in moderate to sever renal impairment. There were no clues in the label regarding investigations to rule out pleiotrophic activity at DDP-IV that might be subclinical in the studies reported in the label but could still be clinically meaningful in a larger, more diverse treatment population. Until such time as this information is made publicly available I advise caution before prescribing Januvia to those at particular risk of adverse effects due to mild suppression of T-cell immunity (i.e. those who are already immunosuppressed for whatever reason).

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