Hyponatremia is the most common electrolyte disorder, reported to occur in 15% to 22% of hospitalized pateints and affecting anywhere from 3 to 6 million patients in the United States each year.
A unique modality to help restore salt and water balance in hospitalized patients

Euvolemic Hyponatremia

Hyponatremia is the most common form of fluid electrolyte imbalance seen in hospitalized patients, characterized by abnormally low sodium levels in the plasma, usually defined as a concentration of <135 mEq/L.1 Hyponatremia is usually diagnosed after primary medical disorders have been identified, and although most cases are mild, acute severe hyponatremia can result in neurological disturbances and increase the risk of morbidity and mortality in underlying disease states.2-4

Depending upon the patient's fluid volume status, hyponatremia can be classified in different ways. VAPRISOL is indicated for the treatment of 2 of these categories: euvolemic hyponatremia and hypervolemic hyponatremia.5,6

  • Euvolemic hyponatremia: The most common type of hyponatremia seen in hospitalized patients. It is defined by normal total body sodium stores and increased total body water and no edema. It may develop in patients with syndrome of inappropriate antidiuretic hormone (SIADH), hypothyroidism, adrenal insufficiency, and pulmonary disorders.2,7-9
  • Hypervolemic hyponatremia: Characterized by an increase in total body water and an increase in total body sodium stores and is evidenced by the presence of edema. Patients with hypervolemic hyponatremia may have underlying congestive heart failure, cirrhosis of the liver, nephrotic syndrome, or renal failure.2,3

There are as many as 6 million people who suffer from hyponatremia annually, incurring costs of up to $3.6 billion.10 A potentially serious condition, hyponatremia remains largely undiagnosed. In a study of more than 120,000 patients, 28% of patients undergoing acute hospital care and 21% of patients undergoing ambulatory care had hyponatremia.11 Another study evaluating hospitalized patients demonstrated that only one-third of hyponatremia cases were properly identified.12 If not managed appropriately, hyponatremia can lead to significant morbidity or mortality.9

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Important 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

References: 1. Janicic N, Verbalis JG. Evaluation and management of hypo-osmolality in hospitalized patients. Endocrinol Metab Clin North Am. 2003;32:459-481. 2. Verbalis JG. Disorders of body water homeostasis. Best Pract Res Clin Endocrinol Metab. 2003;17:471-503. 3. Goh KP. Management of hyponatremia. Am Fam Physician. 2004;69:2387-2394. 4. Goldsmith SR. Current treatments and novel pharmacologic treatments for hyponatremia in congestive heart failure. Am J Cardiol. 2005;95(suppl):14B-23B. 5. Baylis PH. The syndrome of inappropriate antidiuretic hormone secretion. Int J Biochem Cell Biol. 2003;35:1495-1499. 6. Vaprisol Prescribing Information. Astellas Pharma US, Inc. 7. Robertson GL, Aycinena P, Zerbe RL. Neurogenic disorders of osmoregulation. Am J Med. 1982;72:339-353. 8. Bartter FC, Schwartz WB. The syndrome of inappropriate secretion of antidiuretic hormone. Am J Med. 1967;42:790-806. 9. Wong LL, Verbalis JG. Vasopressin V2 receptor antagonists. Cardiovasc Res. 2001;51:391-402. 10. Boscoe A, Paramore C, Verbalis JG. Cost of illness of hyponatremia in the United States. Cost Effectiveness and Resource Allocation. 2006;4:10. doi:10.1/186/1478-7547-4-10. 11. Hawkins RC. Age and gender as risk factors for hyponatremia and hypernatremia. Clin Chim Acta. 2003;337:169-172. 12. Movig KLL, Leufkens HGM, Lenderink AW, Egberts ACG. Validity of hospital discharge International Classification of Diseases (ICD) codes for identifying patients with hyponatremia. J Clin Epidemiol. 2003;56:530-535.