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Important Safety Information Full Prescribing Information

This information is intended for US healthcare professionals

Proven Efficacy

Vaprisol Promotes Prompt, Effective Water Clearance

Study design: Results from a double-blind, placebo-controlled, randomized, multicenter study in patients with euvolemic or hypervolemic hyponatremia (serum sodium 115-130 mEq/L). Fluid restricted to ≤2.0 L/day in all patients.

Patients receiving Vaprisol 40 mg/day IV achieved a cumulative effective water clearance of more than 3.8 L by day 4 (end of treatment) compared with 1.3 L for patients receiving placebo¹*
- Water clearance seen as early as day 1¹

*Baseline-corrected.

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Reference: 1. Vaprisol Prescribing Information. Astellas Pharma US, Inc.

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Vaprisol Works Differently—Find Out How

Learn more about how first-in-class Vaprisol targets AVP to lower serum [Na⁺].

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Using Vaprisol in Your Patients

Learn how to use Vaprisol in a wide range of patients with dilutional hyponatremia.

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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