Safety of KEDRAB

KEDRAB® (Rabies Immune Globulin [Human]) has been evaluated in 4 clinical studies and offers established safety and tolerability in children and adults.

Click on the tabs below to view safety profiles for the pediatric population (6 months to 14 years old) and patients ranging in age from 18 to 72 years.1

Established Safety in Pediatric Patients

Twelve pediatric patients experienced mild adverse reactions within 14 days of taking KEDRAB and rabies vaccine. The most common adverse reactions (>5%) observed in pediatric patients were injection site pain, headache, pyrexia, pain in extremity, bruising, fatigue and vomiting.1

ARs Occurring in >5% of Pediatric Subjects Within 14 Days of Post-exposure Prophylaxis with KEDRAB and Active Rabies Vaccine1

KEDRAB + Rabies Vaccine
(N = 30)
Injection site pain8
(27)
Headache4
(13)
Fever (Pyrexia)4
(13)
Pain in extremity3
(10)
Bruising (Hematoma)2
(7)
Fatigue 2
(7)
Vomiting2
(7)
Data are presented as number of subjects (% of subjects).

Established Safety in Adult Patients

KEDRAB was evaluated in 3 single-center, controlled clinical trials of 160 healthy subjects ranging in age from 18 to 72 years. Ninety-one subjects received single intramuscular doses of KEDRAB (20 IU/kg) with or without rabies vaccine.1

  • The most frequent adverse reactions (>5%) observed in adult subjects were injection site pain, headache, muscle pain, joint pain, dizziness, and fatigue.1

Adverse Reactions Occurring in >3% of Subjects in All Combined Studies in Adults1*

All KEDRAB 
(N = 91)
All Comparator HRIG 
(N = 84) 
Saline Placebo + Vaccine
(N = 8)
Injection site pain 30
(33) 
26
(31) 
2
(25) 
Headache 14
(15) 
11
(13) 
3
(38) 
Muscle pain 8
(9) 
6
(7) 
0
(0) 
Joint pain5
(6)
0
(0)
1
(13)
Dizziness 5
(6)
3
(4)
0
(0)
Fatigue 5
(6)
2
(2)
0
(0)
Abdominal pain 4
(4)
1
(1)
0
(0)
Blood in urine (Hematuria)4
(4)
2
(2)
0
(0)
Nausea 4
(4)
3
(4)
0
(0)
Feeling faint 4
(4)
1
(1)
0
(0)

*Adapted from KEDRAB Prescribing Information.1
Data are represented as the number of subjects (% of subjects). 

FDA-approval for use in children

KEDRAB–the Only HRIG With Established Safety and Effectiveness in Pediatric Patients1

Reference: 1. KEDRAB [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2021. 

SAME KEDRAB, IMPROVED PRODUCT PACKAGING

  • Enhanced color packaging for clear identification of 2mL and 10mL dosage options
  • User-friendly vertical barcodes on vials for easier scanning

New KEDRAB packaging, with distinctive vial sizes and colors, designed to reduce chances of error

Over the next several months, you can expect to start receiving KEDRAB® (Rabies Immune Globulin [Human]) with enhanced product packaging, as pictured above. Products with new packaging will be shipped when available, and after distributors' current supplies become depleted. As such, it is likely you may not receive both the new 2mL and 10mL product packaging at the same time.