FDA Approves New Formulation of Immune Globulin for Post-Exposure Prophylaxis of Hepatitis A & Measles

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.

In addition to hepatitis A and measles, the immune globulin is also approved for rubella and varicella post-exposure prophylaxis.

GamaSTAN will be available in 10 mL and 2 mL vials and is injected intramuscularly. The drug should not be administered intravenously due to the potential for renal failure and lung injuries.

Because the immune globulin is made from human blood, it has the potential to transmit infectious agents. The injection can potentially transmit the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, according to a statement issued by Grifols. The injection may also result in Thrombosis which has been reported in immune globulin products.

Antibodies in the injection may interfere with response to live virus vaccines, therefore, administration of live vaccines should be deferred for up to 6 months following the injection.

The most common adverse reaction related to the drug was fatigue.

In February, the FDA approved Griols’ immune globulin for rabies post-exposure prophylaxis.