Pharmacy & Therapeutics - June 2008 - (Page 306)

WITH VAPRIS OL , THE BUT THE WATER FALLS, S A LT R E M A IN S VAPRISOL is i n d i c a t e d i n h o s p i t a l i z e d p a t i e n t s w i t h e u v o l e m i c or h y p e r v o l e m i c hyponatremia VAPRISOL is not indicated for the treatment of congestive heart failure. It should only be used for the treatment of hyponatremia in patients with underlying heart failure when the expected clinical benefit of raising serum sodium outweighs the increased risk of adverse events for heart failure patients Unique modality of arginine vasopressin (AVP) blockade • VAPRISOL blocks the V2 receptors in the collecting ducts of the kidneys, resulting in aquaresis—the electrolyte-sparing excretion of free water1 Effective aquaresis • VAPRISOL achieved a cumulative increase in effective water clearance of over 3800 mL vs approximately 1300 mL with placebo by day 4 (end of treatment)1,2 Increased serum sodium 1,2 10 8 6 4 2 0 VAPRISOL 40 mg/day IV n=29 Placebo IV n=29 p<.05 at all timepoints -2 0 8 16 24 32 40 48 56 64 72 80 88 96 Hours Important Safety Information • VAPRISOL is contraindicated in patients with hypovolemic hyponatremia. In addition, coadministration of VAPRISOL with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritanovir, and indinavir, is contraindicated • Serum sodium, volume, and neurological status must be monitored frequently because VAPRISOL potentially can cause overly rapid correction of sodium leading to serious sequelae • The use of VAPRISOL in patients with hepatic impairment (including ascites, cirrhosis, or portal hypertension) or renal impairment has not been systematically evaluated. Use caution when administering VAPRISOL to these patients • The most common adverse reactions reported were infusion site reactions (incidence of 73% and 63% for 20 mg/day and 40 mg/day, respectively) which were also the most common type of adverse reaction leading to discontinuation of VAPRISOL. Discontinuations from treatment due to infusion site reactions were more common among VAPRISOL-treated patients (3%) than among placebo-treated patients (0%). Other common adverse reactions were headaches (8%, 10%), hypokalemia (22%, 10%), orthostatic hypotension (14%, 6%), and pyrexia (11%, 5%) for VAPRISOL 20 mg/day and 40 mg/day, respectively Please refer to adjacent Brief Summary of Prescribing Information. ©2007 Astellas Pharma US, Inc. VAP02058 09/07 http://www.vaprisol.com

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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