FDA approves GamaSTAN for HAV, measles exposure
The FDA has approved a new formulation of Grifols’ GamaSTAN immune globulin for hepatitis A virus and measles post-exposure prophylaxis, the company announced.
“GamaSTAN is the only immune globulin product on the U.S. market approved for post-exposure protection against hepatitis A (HAV) and measles,” Nikhil Gandhi, director of marketing for specialty products at Grifols, told Infectious Disease News.
The CDC recommends immune globulin for treatment after exposure to HAV in adults aged 40 years or older, children younger than age 12 months, immunocompromised persons, persons with cancer or chronic liver and disease and persons who are allergic to the HAV vaccine or a vaccine component.
“When administered within 2 weeks after exposure to HAV, immune globulin is 80% to 90% effective in preventing hepatitis A infection,” Gandhi explained.
GamaSTAN is contraindicated in patients who have had anaphylactic or severe systemic hypersensitivity reactions to immune globulin and patients with immunoglobulin A (IgA) deficiency with antibodies against IgA and a history of hypersensitivity, according to a news release.
GamaSTAN is also approved for rubella and varicella post-exposure prophylaxis. Grifols offers vials of GamaSTAN in 10-mL and 2-mL sizes.
“GamaSTAN was first approved in 1944. However, this new formulation is now manufactured using a sophisticated caprylate chromatography process,” Gandhi said. “Grifols is committed to continuously improving its products.” – by Marley Ghizzone
Disclosure: Gandhi works for Grifols.