Posted from: Monday, October 08, 2018 - 12:33 PM - Present

New Formulation of GamaSTAN Approved

September 4, 2018 – The U.S. FDA has approved a new formulation of GamaSTAN® (immune globulin [human]), manufactured by Grifols, to provide post-exposure prophylaxis for hepatitis A virus (HAV) infection and measles. It is the only immune globulin product on the U.S. market to carry this indication.

Unlike vaccinations, which may require several weeks to take full effect, GamaSTAN can provide immediate protection to individuals who have been exposed to HAV or measles. To be effective against HAV, GamaSTAN must be given prior to the patient exhibiting clinical signs of infection, and no more than two weeks following exposure. For measles, GamaSTAN should only be given to individuals who have not been previously vaccinated against the disease and who have never contracted measles in the past. It must be administered no more than six days following exposure. Immunocompromised children who have not been vaccinated against measles should receive GamaSTAN immediately upon exposure.

GamaSTAN requires intramuscular injection, and its recommended dosing depends on the indication, as well as patient weight and other factors. Individuals treated with GamaSTAN for prevention of measles should not receive a measles vaccine for at least three months following treatment. According to a black box warning, immune globulins like GamaSTAN may cause thrombosis (blood clots).

In addition to its new indications for HAV and measles, GamaSTAN is FDA-approved to provide passive immunization against the varicella-zoster virus (chicken pox), and to modify rubella in exposed pregnant women. Human immune globulin, the active ingredient, first received FDA approval in 1944.

 

Last Updated Friday, October 19, 2018 - 06:08 PM.