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Important Safety Information Full Prescribing Information

This information is intended for US healthcare professionals

Proven Efficacy

Increased Serum Sodium Concentration Is Maintained After Day 4*

Study design: Results of an open-label study of 251 patients with euvolemic or hypervolemic hyponatremia. Patients were treated for 4 days with Vaprisol 20 mg/day IV or 40 mg/day IV (n=37, n=214, respectively) following a 20-mg loading dose via 30-minute IV infusion. The mean baseline serum sodium concentration in patients treated with Vaprisol 40 mg/day IV was 123.8 mEq/L.

In an open-label study:

Mean changes in serum sodium concentration from baseline to day 4 (end of treatment) in patients receiving Vaprisol 20 mg/day IV or 40 mg/day IV were 9.4 mEq/L and 8.8 mEq/L, respectively¹
78% of patients receiving Vaprisol 20 mg/day IV and 83% of patients receiving Vaprisol 40 mg/day IV achieved a ≥4 mEq/L increase in serum sodium concentration by day 4 (end of treatment)¹
Increased serum sodium concentration was maintained for up to 30 days post treatment^1*

*The effect of Vaprisol on maintenance of serum sodium concentration is not known.

NEXT: Effective Water Clearance

References: 1. Vaprisol Prescribing Information, Astellas Pharma US, Inc. 2. Data on file. Astellas.

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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, ritonavir, 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