Grifols announced that the Food and Drug Administration (FDA) has approved a new higher potency formulation of HyperRAB (rabies immune globulin [human]) for rabies post-exposure prophylaxis. 

The new formulation has twice the potency (300 IU/mL) of currently available rabies immune globulin options. This allows for fewer injections, along with a significantly lower volume of the drug administered in each dose.

“Because patients are required to be dosed by weight, the increased potency of this new formulation allows more rabies antibodies per mL to go directly into wounds in delicate areas, such as the extremities or face. Administration in these areas has proven to be very uncomfortable for patients, especially children, and challenging for healthcare professionals in administration of the full dose,” said Dr. Charles Rupprecht, expert technical advisor on rabies for the PAHO/WHO, and former chief of the rabies program at the Centers for Disease Control and Prevention (CDC). 

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Currently, the Advisory Committee on Immunization Practice (ACIP) recommends unvaccinated individuals to receive immediate prophylaxis upon exposure to rabies, including a rabies immune globulin injection directly into the wound site to prevent the virus from entering the central nervous system. 

HyperRAB for intramuscular injection will be supplied as 1mL/300 IU and 5mL/1500 IU sizes in single-dose vials.

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