Safety Information

• VAPRISOL is indicated for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients
• 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 benefit of raising serum sodium outweighs the increased risk of adverse events
• 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