Astellas Pharma US has announced that the FDA has approved a new premixed formulation of Vaprisol: Vaprisol premixed in 5% dextrose.
Discovered and developed by Astellas, Vaprisol, an arginine vasopressin receptor antagonist, is said to be the first and only approved drug indicated for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.
The 100ml, single-use premixed formulation of Vaprisol comes in an Intravia container, a product of Baxter Healthcare, containing 20mg of conivaptan hydrochloride in 5% dextrose solution. Lactic acid, USP is added for pH adjustment to pH 3.4 to 3.8.
According to the company, 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.
Joseph Verbalis, professor of medicine and physiology at Georgetown University, said: "Vaprisol premixed in 5% dextrose will be helpful in quickly preparing treatment for hyponatremia patients. This ready-to- use product will be useful for hospitals and emergency rooms."