Indications for: KEDRAB

Post-exposure prophylaxis of rabies infection, to be given with a full course of rabies vaccine.

Clinical Trials:

The efficacy of Kedrab given concurrently with the rabies vaccine was studied in a single-center, randomized, comparator human rabies immune globulin (HRIG)-controlled clinical study. Patients were healthy adults 18–72 years of age who had no significant acute or chronic illness. A total of 118 patients (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 mean age of study patients was 45 years. 

  • The efficacy variable was rabies virus neutralizing activity (RVNA), as assessed by Rapid Fluorescent Focus Inhibition Test (RFFIT), on Day 14.
  • Efficacy analyses were performed on the As-Treated Population, which comprised 116 study patients 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 patients (98.2%) in the Kedrab group versus 59/59 patients (100%) 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.

Kedrab was also evaluated in a two-center, open-label clinical trial in 30 pediatric patients exposed or possibly exposed to rabies virus for whom post-exposure prophylaxis was indicated. Patients were treated with Kedrab at a dose of 20 IU/kg on Day 0 and active rabies vaccine on Days 0, 3, 7, and 14 as per ACIP recommendations for rabies post-exposure prophylaxis. The patients ranged in age from 0.5–14.9 years. 

  • The efficacy variables were RVNA as assessed by RFFIT on Day 14 and occurrence of rabies disease through Day 84 after administration of Kedrab.
  • Efficacy analyses were performed on the As-Treated Population, which comprised all 30 study patients.
  • In the As-Treated Population, the geometric mean (SD) Day-14 RVNA titer was 18.89 (31.61) IU/mL and the median Day-14 RVNA titer was 8.81 (range 0.21–153.62) IU/mL.
  • Of the 30 treated pediatric patients, 28 patients (93.3%) had a Day-14 RVNA titer ≥0.5 IU/mL, the WHO recommended level. None of the 28/30 patients who were followed for the duration of the study developed rabies infection through day 84.

Adults and Children:

Prior to administration, follow recommendations for local treatment of wounds. Not previously vaccinated: administer as soon as possible after exposure; may give up to 7 days after first vaccine dose. 20 IU/kg as single dose with first dose of rabies vaccine. If feasible, infiltrate dose into and around the wound; inj remainder, if any, via IM into an anatomical site distant from the rabies vaccine site. Avoid repeat doses of Kedrab once vaccine treatment is initiated. Use separate syringes, needles, and anatomical inj sites for Kedrab and for rabies vaccine.

KEDRAB Warnings/Precautions:

Previously completed pre- or post-exposure vaccination and confirmed adequate rabies titer: not recommended. Have epinephrine available. History of allergic reactions to human immunoglobulins; monitor. IgA deficiency. Contains human plasma; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Pregnancy. Nursing mothers.

KEDRAB Classification:

Immune globulin.

KEDRAB Interactions:

Avoid measles vaccine within 4 months of Kedrab; avoid other live attenuated vaccines within 3 months. May interfere with serologic tests (eg, Coombs’ test).

Adverse Reactions:

Inj site pain, headache, muscle pain, joint pain, dizziness, fatigue, pyrexia, extremity pain, bruising, vomiting; anaphylaxis.

Drug Elimination:

Half-life: ~17.9 days. 

Generic Drug Availability:


How Supplied:

Single-use vial (2mL, 10mL)—1