The US Food and Drug Administration (FDA) has approved a new formulation of Grifols' GamaSTAN immune globulin (human) for prophylaxis following exposure to hepatitis A virus (HAV) and for prevention or modification of measles in susceptible individuals exposed fewer than 6 days previously.
The new formulation is manufactured using a caprylate chromatography process in accord with the highest quality and safety standards, according to the company.
GamaSTAN is the only immune globulin product available in the United States to protect against HAV and measles following exposure, the company said in a news release. GamaSTAN for intramuscular injection comes in two vial sizes (10 mL and 2 mL).
The US Centers for Disease Control and Prevention (CDC) recommends immune globulin as HAV postexposure prophylaxis for people who are immunocompromised, younger than 1 year of age, older than 40 years of age, or have cancer or chronic liver and kidney disease.
"Vaccination, while a valuable option for hepatitis A and measles post-exposure prophylaxis, may take several weeks to take effect as [the] immune system works to build the antibodies it needs to fight these viruses.
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," Stephen Scholand, MD, infectious disease specialist at MidState Medical Center in Meriden, Connecticut, said in the release.
In addition to HAV and measles, GamaSTAN is also approved for postexposure prophylaxis of varicella and rubella. It is not indicated for routine prophylaxis or treatment of viral hepatitis type B, rubella, poliomyelitis, mumps, or varicella.
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.
Thrombosis may occur with immune globulin products, including GamaSTAN. Patients at increased risk for thrombosis may include the elderly, those with prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, indwelling central vascular catheters, hyperviscosity, or cardiovascular risk factors, as well as patients who use estrogens. Full prescribing information for GamaSTAN is available online.