Grifols announced the US launch of HyperHEP B® for hepatitis B postexposure prophylaxis.
HyperHEP B is the Company’s new formulation of its hepatitis B Immune globulin. It is indicated for postexposure prophylaxis in the following settings: acute exposure to blood containing hepatitis B surface antigen (HBsAg), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to an HBsAg-positive person and household exposure to persons with acute HBV infection.
The latest formulation is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. According to the Company, the caprylate chromatography process significantly reduces procoagulant activity and immunoglobulin G aggregates. Additionally, the manufacturing process provides several steps with the capacity for viral inactivation or removal.
HyperHEP B is now available in a 0.5mL neonatal syringe, a 1mL vial, and a 5mL vial, through all major distributors. Each vial or syringe contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a US reference hepatitis B immune globulin (established by the Center for Biologics Evaluation and Research, FDA).
- Grifols introduces HyperHEP B® (hepatitis B immune globulin [human]), a new formulation to treat patients exposed to hepatitis B. [press release]. Research Triangle Park, NC; June 1, 2021.
- HyperHEB B [package insert]. Research Triangle Park, NC: Grifols Therapeutics; 2021.