Grifols, a leading global producer of plasma-derived medicines, announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of its GamaSTAN® immune globulin (human) for hepatitis A virus (HAV) and measles postexposure prophylaxis. GamaSTAN® is now available to healthcare providers across the country.
GamaSTAN® is the only immune globulin product on the U.S. market approved for immediate protection against HAV and measles. The FDA approval is an important R&D milestone for Grifols as a global leader in postexposure prophylaxis (the treatment of a person after exposure to a virus) and immune globulin products for patients.
GamaSTAN® is contraindicated in patients who have had anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human) and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.
“Vaccination, while a valuable option for hepatitis A and measles postexposure prophylaxis, may take several weeks to take effect as your immune system works to build the antibodies it needs to fight these viruses,” said Dr. Stephen Scholand, Infectious Disease Specialist at MidState Medical Center. “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 states that for persons aged more than 40 years, an immune globulin is preferred for HAV postexposure prophylaxis. The CDC also recommends that immune globulin should be used for children aged less than 12 months, immunocompromised persons, persons with chronic liver disease, and persons who are allergic to the vaccine or a vaccine component. When administered within 2 weeks after exposure to HAV, immune globulin is 80 to 90 percent effective in preventing hepatitis A infection.
In addition to HAV and measles, GamaSTAN® is also approved for rubella and varicella postexposure prophylaxis.
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