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Important Safety Information
Full Prescribing Information




This information is intended for US healthcare professionals

Safety and Tolerability

Vaprisol has a demonstrated safety profile, with studies conducted in more than 1100 hospitalized patients.1

Discontinuations from treatment due to infusion site reactions were more common among Vaprisol-treated patients (3%) than among placebo-treated patients (0%).2

It is important to note that there was no demonstrated osmotic demyelination in clinical trials with Vaprisol.2 In controlled clinical trials of Vaprisol, about 9% of patients who received Vaprisol in doses of 20-40 mg/day IV met laboratory criteria for overly rapid correction of serum sodium, but none of these patients had permanent neurologic sequelae.2

Most common adverse events with Vaprisol2*
% Placebo
(n=69)		 % Vaprisol 20 mg
(n=37)		 % Vaprisol 40 mg
(n=315)
Anemia NOS† 3 5 6
Atrial fibrillation 0 5 2
Confusional state 3 0 5
Constipation 3 8 6
Diarrhea NOS† 0 0 7
Edema peripheral 1 3 8
Electrocardiogram
ST segment
depression		 0 5 0
Headache 3 8 10
Hypertension NOS† 0 8 6
Hypokalemia 3 22 10
Hypomagnesemia 0 5 2
Hyponatremia 1 8 6
Hypotension NOS† 3 8 5
Infusion
site erythema		 0 0 6
Infusion site pain 1 0 5
Infusion
site phlebitis 		1 51 32
Infusion
site reaction		 0 22 19
Insomnia 0 5 4
Nausea 4 3 5
Orthostatic
hypotension		 0 14 6
Pharyngolaryngeal
pain		 4 5 1
Pneumonia NOS† 0 5 2
Postprocedural
diarrhea		 0 5 0
Pruritus 0 5 1
Pyrexia 0 11 5
Thirst 1 3 6
Urinary tract
infection NOS†		 3 5 4
Vomiting NOS† 0 5 7

*Incidence of ≥5% and higher than placebo from the Prescribing Information for Vaprisol.
†Not otherwise specified.

Safety in geriatric patients
  • In clinical studies of intravenous Vaprisol, 89% (20 mg/day regimen) and 60% (40 mg/day regimen) of participants were at least 65 years of age and 60% (20 mg/day regimen) and 40% (40 mg/day regimen) were at least 75 years of age2
  • Adverse event profile in this patient group was similar to the general study population2

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

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Vaprisol Provides Proven Efficacy

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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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