Company: Kedrion Biopharma
Approval Status: Approved August 2017
Specific Treatments: post-exposure prophylaxis of rabies infection
Therapeutic Areas Infections and Infectious Diseases
KedRab is a human rabies immunoglobulin (HRIG).
KedRab is specifically indicated for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal.
KedRab is supplied as a solution for intramuscular injection. KedRab should be administered concurrently with a full course of rabies vaccine. Do not administer additional (repeat) doses of KedRab once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine. Do not administer KedRab to persons with a history of a complete preexposure or post-exposure rabies vaccination and confirmed adequate rabies antibody titer. For wound infiltration and intramuscular use: Post-exposure prophylaxis consists of a single dose of KedRab and a full course of rabies vaccine. Administer KedRab and the rabies vaccine as soon as possible after exposure. Dosage: 20 IU/kg body weight. Infiltrate as much of the dose as possible into and around the exposure site (if visible); administer the remainder intramuscularly at sites distant from the site of vaccination.
The FDA approval of KedRab was based on a single center, randomized, comparator HRIG-controlled clinical study. Study subjects were healthy adults 18 to 72 years of age who were without significant acute or chronic illness. A total of 118 subjects (59 per treatment group) received intramuscular KedRab or comparator HRIG at a dose of 20 IU/kg on Day 0, and rabies vaccine on Days 0, 3, 7, 14 and 28. The efficacy variable was RVNA, as assessed by RFFIT, on Day 14. Efficacy analyses were performed on the As-Treated Population, which comprised the 116 study subjects who received KedRab or comparator HRIG and at least 3 of the 5 doses of rabies vaccine before Day 14. Efficacy, considered when RVNA titer is 0.5 IU/mL or higher on Day 14 (as established by the WHO), was met by 56/57 subjects (98.2%) in the KedRab group and 59/59 subjects in the comparator HRIG group. The lower limit of the 90% CI was greater than the pre-specified non-inferiority margin of -10%; thus, KedRab was non-inferior to comparator HRIG.
Adverse effects associated with the use of KedRab may include, but are not limited to, the following:
- injection site pain
- muscle pain
- upper respiratory tract infection
Mechanism of Action
KedRab is a human rabies immunoglobulin (HRIG). Rabies is a zoonotic disease caused by RNA viruses in the family Rhabdoviridae, genus Lyssavirus. Virus is typically present in the saliva of rabid mammals and is transmitted primarily through a bite. KedRab is infiltrated into the inoculation site (i.e., at the beginning of anti-rabies PEP) to previously unvaccinated persons, to provide immediate passive rabies virus neutralizing antibody protection until the patient’s immune system responds to vaccination by actively producing antibodies.
For additional information regarding KedRab or rabies infection/prophylaxis, please visit http://www.kedrab.com/KEDRAB-prescribing-information.pdf