FDA Approves Astellas' Vaprisol Premixed In Dextrose
Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of Vaprisol: Vaprisol (conivaptan hydrochloride injection) Premixed in 5% Dextrose. Discovered and developed by Astellas, Vaprisol, an arginine vasopressin (AVP) receptor antagonist, is the first and only approved drug indicated for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients. Hyponatremia is a potentially life-threatening condition that occurs when the body's blood sodium level falls significantly below normal. Vaprisol was originally approved by the FDA in an ampule formulation for the treatment of euvolemic hyponatremia in December 2005 and hypervolemic hyponatremia in February 2007.
The 100mL, single-use premixed formulation of Vaprisol comes in an INTRAVIA Container, a product of Baxter Healthcare Corporation, containing 20 mg of conivaptan hydrochloride in 5% Dextrose solution. Lactic acid, USP is added for pH adjustment to pH 3.4 to 3.8. The new formulation will make preparation easier for health care providers as it is requires no measuring or mixing. Additionally, it has an expiration date of 24 months, six months longer than the original ampule formulation.
"Vaprisol Premixed in 5% Dextrose will be helpful in quickly preparing treatment for hyponatremia patients," said Dr. Joseph Verbalis, M.D., Professor of Medicine and Physiology at Georgetown University. "This ready-to- use product will be useful for hospitals and emergency rooms."
Hyponatremia is present in approximately 28 percent of patients upon admission into acute hospital care and another 14 percent acquire the condition while in acute care. Severe cases are medical emergencies that can result in swelling of the brain, respiratory arrest, catastrophic brain damage and death.
In the treatment of hyponatremia associated with congestive heart failure, Vaprisol is indicated only for those patients for whom the expected benefit of raising serum sodium outweighs the increased risk of adverse events. Vaprisol is contraindicated in patients with hypovolemic hyponatremia.
Hyponatremia, a condition of low serum sodium concentration, often results from elevated levels of the hormone arginine vasopressin (AVP), which regulates water and salt balance in the body. It is the most common electrolyte disorder in clinical medicine and one of the most difficult to treat. Syndrome of inappropriate antidiuretic hormone (SIADH), advanced kidney failure, hypothyroidism and cancer are common causes of hyponatremia. Dilutional hyponatremia, which includes euvolemic and hypervolemic hyponatremia, is the most common form of the condition, and occurs when retained water dilutes serum sodium content. Patients with hyponatremia are classified as hypervolemic if swelling of body tissues (edema) is present or euvolemic if there is an increase in total body water content without edema.