FDA OKs New Immune Globulin Formulation for Hepatitis A, Measles Post-Exposure Prophylaxis

The US Food and Drug Administration (FDA) has approved Grifols’ new formulation of immune globulin (GamaSTAN) for hepatitis A virus and measles post-exposure prophylaxis.

Currently, the new formulation is the only immune globulin available in the United States that is approved for post-exposure protection against hepatitis A and measles.

The immune globulin is a new formulation that uses a caprylate chromatography process which removes prions. The drug is contraindicated in patients who have anaphylaxis or severe sensitivity reactions to immune globulin and in IgA-deficient patients with antibodies against IgA.

"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," Stephen Scholand, MD, infectious disease specialist at MidState Medical Center, said in a recent

statement

. "Immune globulins such as GamaSTAN

^®

have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection."

The CDC recommends immune globulin as hepatitis A post-exposure prophylaxis treatment for individuals who have weakened immune systems, infants <1 year, adults over 40, and individuals with cancer or chronic liver or kidney disease. When administered within 2 weeks after exposure to hepatitis A, immune globulin is 80% to 90% effective in preventing hepatitis A infection.

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