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 pain | 8 (27) |
| Headache | 4 (13) |
| Fever (Pyrexia) | 4 (13) |
| Pain in extremity | 3 (10) |
| Bruising (Hematoma) | 2 (7) |
| Fatigue | 2 (7) |
| Vomiting | 2 (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 pain | 5 (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).
Reference: 1. KEDRAB [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2021.