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FDA Approves New Formulation of HepA Immune Globulin

— Product also offers post-exposure prophylaxis against measles

MedpageToday

The FDA approved a new formulation of an immune globulin product for hepatitis A and measles post-exposure prophylaxis, by Grifols, the manufacturer.

This new formulation of GamaSTAN immune globulin -- using what Grifols called a "sophisticated caprylate chromatography process" -- is "the only immune globulin product on the U.S. market approved for post-exposure protection against hepatitis A and measles," the company said.

Post-exposure prophylaxis for hepatitis A received special attention recently, when the CDC's Advisory Committee for Immunization Practices (ACIP) voted in February that vaccination against hepatitis A should be given following exposure for all persons age ≥12 months, but added that "immune globulin should be administered to adults ages 40 and older," pending the healthcare professional's risk assessment.

Current CDC guidelines about also state that immune globulin should be used for post-exposure prophylaxis for children ages <12 months, immunocompromised persons, persons with chronic liver disease, and those allergic to the vaccine or its components. Immune globulin is also an option for international travelers heading to an area with "high to intermediate risk" of hepatitis A.

"Vaccination, while a valuable option for hepatitis A and measles post-exposure prophylaxis, may take several weeks to take effect as your immune system works to build the antibodies it needs to fight these viruses," said Stephen Scholand, MD, an infectious disease specialist at MidState Medical Center in Meriden, Conn., in the Grifols statement. "Immune globulins ... have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection."

GamaSTAN is indicated both for hepatitis A post-exposure prophylaxis and "prevention or modification of measles in susceptible persons exposed less than 6 days previously," as well as "modification of varicella, and modification of rubella in exposed women who will not consider a therapeutic abortion." It is contraindicated in patients with anaphylactic or severe systemic hypersensitivity reactions to immune globulin and in "IgA-deficient patients with antibodies against IgA and a history of hypersensitivity," said Grifols.