FDA Extends Shelf Life of Hizentra to 30 Months
- By BSTQ Staff
TheU.S.Food andDrugAdministration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 24 months to 30 months. Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature (up to 25 degrees Centigrade or 77 degrees Fahrenheit)for up to 30 months, and because no refrigeration is necessary, it can be ready to use without warning, offering patients and physicians convenience and portability.
Hizentra is the first and only 20 percent subcutaneous immune globulin approved in the U.S.It is indicated for the treatment of primary humoral immunodeficiency, a group of disorders that result from a dysfunctional immune system that prevent patients from fighting off infections caused by common germs.