Program Description

Hyponatremia is the most common electrolyte disorder, estimated to occur in up to 30% of hospitalized patients.  This Medical Industry Feature of the Week, sponsored by Astellas Pharma US Inc, provides an overview of management of hyponatremia in the hospital setting with a specific focus on a new class of agents, the AVP receptor antagonists. Vaprisol^® (conivaptan hydrochloride injection) is the first FDA approved drug in this class and we will be reviewing some of the data that supported the FDA approval.

Host Dr. Lee Freedman welcomes Dr. Scott Beegle, Assistant Professor of Medicine at Albany Medical College and Dr. Joseph Verbalis, Professor of Medicine and Physiology at Georgetown University Medical Center to provide information about the clinical presentation and treatment of  patients with euvolemic and hypervolemic hyponatremia and the role of Vaprisol in the treatment of these patients.

Indication

• 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

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

For full prescribing information, click here. 

 

Series

Medical Industry Feature of the Week

Guests

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