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May 20, 2021Kedrab Approval Expanded to Prevent Rabies in Children
May 20, 2021 – The U.S. FDA has approved an expanded indication for Kedrab® [rabies immune globulin (human)] solution for wound infiltration and intramuscular injection. The product, which is manufactured by Kedrion Biopharma, was previously indicated to provide passive, transient post-exposure prophylaxis (PEP) of rabies infection in adults when given immediately after contact with a rabid or possibly rabid animal. It is now approved for this indication in people of all ages.
Caused by a virus, rabies is almost always fatal without proper treatment. It’s primarily transmitted to humans through a bite or scratch from an infected animal. The safety of Kedrab in pediatric patients was established in a clinical study where it was used as part of rabies PEP in children up to 17 years of age who had exposure or suspected exposure to an animal suspected or confirmed to be rabid.
Post-exposure prophylaxis requires a single dose of Kedrab (20 IU/kg of the patient’s body weight) administered as soon as possible after exposure. It should be used in conjunction with a full course of rabies vaccine. According to the prescribing information, a healthcare provided should infiltrate as much of the dose as possible into and around the exposure site if feasible and give the remainder via intramuscular (IM) injection at sites distant from the site of rabies vaccination. If infiltration is not feasible, the full dose should be given by IM injection at a site distant from the vaccination site.
Kedrab first received FDA approval in 2017.