KEDRAB MONOGRAPH—A COMPREHENSIVE RESOURCE

FORMULARY MONOGRAPH

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

Information Inside this Monograph

Rabies disease

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

Rabies PEP

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 at a Glance

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

1. KEDRAB provides passive, transient PEP of rabies infection, when given immediately after contact with a rabid or possibly rabid animal and should be administered concurrently with a full course of rabies vaccine.⁷
2. A large-scale study in 118 healthy volunteers indicated that KEDRAB resulted in rabies virus neutralizing antibody titer ≥0.5 IU/mL, demonstrating noninferiority of KEDRAB to the comparator marketed HRIG.⁷