The KEDRAB Formulary Monograph provides detailed information about the rabies virus (RABV) and how it damages the nervous system, vectors for infection, current PEP guidelines, and a complete description of the efficacy and safety of KEDRABTM (Rabies Immune Globulin [Human]) and how it should be used in PEP for rabies.
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Rabies can be transmitted by bites from or the saliva of both wild and domestic animals. Bats constitute the most common source of human rabies cases in the United States.1 Rabies infection begins with a bite/scratch contaminated with infected saliva.2 The virus enters muscle cells, evades detection and destruction by the immune system, replicates, and then travels rapidly to reach the central nervous system (CNS).3 Once symptoms emerge, no treatment is proven to prevent progression to death.4
PEP can prevent death due to rabies infection. For every patient not previously vaccinated against rabies, PEP must include wound cleansing, passive immunization with human rabies immune globulin (HRIG), and administration of rabies vaccine.5 Every year, an estimated 40,000 people in the United States receive PEP after contact with a possibly rabid animal.6
KEDRAB is a sterile, aqueous ready-to-use solution with a nominal potency of 150 IU/mL of anti-rabies immune globulin (human).7 It is prepared by chromatographic fractionation from a pool of plasma collected from selected adult human donors who have been immunized with rabies vaccine and have developed high titers of anti-rabies antibody.8 Three specific viral inactivation/removal steps are employed in the manufacture of KEDRAB to provide a safe product: solvent/detergent treatment, heat treatment (pasteurization), and nanofiltration.8
References: 1. Centers for Disease Control and Prevention. Learning about bats and rabies. https://www.cdc.gov/rabies/bats/education/. Updated April 22, 2011. Accessed June 9, 2017. 2. World Health Organization. Media centre rabies fact sheet. http://www.who.int/mediacentre/factsheets/fs099/en/. Updated March 2017. Accessed July 10, 2017. 3. Scott TP, Nel LH. Subversion of the immune response by rabies virus. Viruses. 2016;8(8):E231. 4. Rupprecht C, Kuzmin I, Meslin F. Lyssaviruses and rabies: current conundrums, concerns, contradictions and controversies. F1000Research. 2017;6(F1000 Faculty Rev):184. doi: 10.12688/f1000research.10416.1. 5. Centers for Disease Control and Prevention. Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2010;59(2):1-9. 6. Centers for Disease Control and Prevention. Take a bite out of rabies! https://www.cdc.gov/features/rabies/. Updated September 26, 2016. Accessed June 12, 2017. 7. KEDRAB [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2017. 8. Data on file. Kamada Ltd.