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Formulary Monograph

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KEDRAB Formulary Monograph

Key Facts About Rabies and Post-exposure Prophylaxis (PEP)

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, a complete description of the efficacy and safety of KEDRAB® (Rabies Immune Globulin [Human]), and how KEDRAB should be used in PEP for rabies.

Important Information Inside the Monograph

Rabies Disease

  1. Human infection occurs when the virus is transmitted through the saliva of an infected animal by either a bite or scratch.1 The virus enters muscle cells, evades detection and destruction by the immune system, replicates, and then travels rapidly within axons to reach the central nervous system (CNS). The rabies virus damages neurons and may also kill some of these cells. This results in brain dysfunction that ultimately leads to death.2
  2. The initial symptoms of rabies are fever and often pain or an unusual or unexplained tingling, pricking, or burning sensation at the wound site.3 Other symptoms, including hyperactivity, agitation, hydrophobia (fear of water), hypersalivation, and seizures, emerge after the virus reaches the CNS. Once these symptoms emerge, no treatment is proven to prevent progression to death.4,5
  3. 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.6

 

Rabies PEP

PEP can prevent death due to rabies infection. For every patient not previously vaccinated against rabies, PEP should include wound cleansing, passive immunization with human rabies immune globulin (HRIG), and administration of rabies vaccine.7 Every year, an estimated 55,000 people in the United States receive PEP after contact with a possibly rabid animal.8

 

KEDRAB at a Glance

  1. KEDRAB is a sterile, non-pyrogenic aqueous solution with a nominal potency of 150 IU/mL of anti-rabies immune globulin (human). It is prepared from a pool of plasma collected from selected adult human donors who have been hyperimmunized with rabies vaccine and have developed high titers of anti-rabies antibody.1,9  Three specific viral inactivation/removal steps are employed in the manufacture of KEDRAB: solvent/detergent (S/D) treatment, heat treatment (pasteurization), and nanofiltration.9
  2. KEDRAB provides passive, transient PEP of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.9
  3. A large-scale study in 118 healthy volunteers indicated that KEDRAB resulted in a rabies virus neutralizing antibody titer ≥0.5 IU/mL (the World Health Organization [WHO] recommended protective level), demonstrating noninferiority of KEDRAB to the comparator marketed HRIG.9

References: 1. Data on file. Kamada Ltd. 2. Scott TP, Nel LH. Subversion of the immune response by rabies virus. Viruses. 2016;8(8):231. 3. World Health Organization. Media centre rabies fact sheet. http://www.who.int/mediacentre/factsheets/fs099/en/. Updated April 2020. Accessed October 19, 2020. 4. Ghosh JB, Roy M, Lahiri K, Bala AK, Roy M. Acute flaccid paralysis due to rabies. J Pediatr Neurosci. 2009;4(1):33-35. 5. 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. 6. Centers for Disease Control and Prevention. Learning about bats and rabies. https://www.cdc.gov/rabies/bats/education/. Updated April 22, 2011. Accessed October 19, 2020. 7. 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. 8. Centers for Disease Control and Prevention. The burden of rabies. https://www.cdc.gov/Features/dsRabies/index.html. Updated September 26, 2016. Accessed October 19, 2020. 9. KEDRAB [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2021.