A Safety Profile You Can Count On1
Incidence of clinical adverse reactions in studies of CroFab®
||Number of Adverse Reactions (N=42)*
*Of the 42 patients receiving CroFab® in the clinical studies, 19 experienced an adverse reaction. A total of 26 adverse reactions were experienced by these 19 patients.
†Allergic reactions consisted of urticaria, dyspnea, and wheezing in 1 patient.
‡Serum sickness consisted of severe rash and pruritus in 1 patient.
§Six of 42 patients experienced an adverse reaction associated with an early serum reaction, and 4 experienced an adverse reaction associated with a late serum reaction. Two additional patients were considered to have a late serum reaction by the investigator, although no associated adverse reaction was reported.
|Body as a Whole
||4 - Back pain (2), allergic reactions† (1), serum sickness‡ (1)
|Skin and Appendages
||13 - Urticaria (7), rash (3), pruritus (2), subcutaneous nodule (1)
||1 - Cough (1)
||4 - Nausea (3), anorexia (1)
||2 - Coagulation disorder (1), ecchymosis (1)
||1 - Myalgia
||1 - Nervousness (1)
|Early Serum Reactions§
||7 - Urticaria (5), cough (1), allergic reactions† (1)
|Late Serum Reactions§
||5 - Rash (2), pruritus (1), urticaria (1), serum sickness‡ (1)
Since 2001, safety data have been collected on CroFab® in the treatment of North American pit viper envenomation.
In a meta-analysis of 11 studies involving 504 patients treated with CroFab® that included 2 pre-marketing studies, the incidence of immediate hypersensitivity reactions and serum sickness was 8% (95% CI = 5% to 11%) and 13% (95% CI = 7% to 21%), respectively.2¶
- Sensitivity analysis excluding 2 premarketing trials, one with potential Fc contamination, reduced the estimated serum sickness to 8% (95% CI = 4% to 16%)
In the American College of Medical Toxicology’s North American Snakebite Registry, a prospective case registry of snake‐envenomed patients, 373 patients were treated with CroFab® over a 3‐year period (2013‐2015).3
- Acute adverse events were observed in 10 of the 373 patients (2.7%)
- Rash, including urticaria, was the most common event, occurring in 6 patients (1.6%)
- Hypotension, bronchospasm, and angioedema occurred in 4 patients (1.1%)
- Limitations of this publication include that it is based on a post-marketing registry, which is limited by the voluntary nature of the reporting
A Retrospective Study of Postmarketing Use of CroFab®
Reported 36 Immediate Adverse Drug Reactions in 6.1% (15/247) of Patients, Including4:
- 11 immediate serious adverse reactions related to CroFab® in 4 patients: 2 episodes each of hypotension and tongue swelling, and 1 episode each of chest discomfort, angioedema, bronchospasm, wheezing, tracheal edema, dyspnea, and lip swelling
- 22 immediate nonserious adverse reactions related to CroFab® in 12 patients: 4 episodes each of rash and pruritus, 3 of urticaria, and 1 each of tachycardia, tachypnea, erythema, swelling, hyperhidrosis, dizziness, headache, musculoskeletal chest pain, chills, feeling cold, and nervousness
- 2 patients reported delayed hypersensitivity reactions
CroFab® is produced with purity, precision, and purpose.
1. CroFab® [prescribing Information]. BTG International Inc; January 2018. 2. Schaeffer TH, Khatri V, Reifler LM, Lavonas EJ. Incidence of immediate hypersensitivity reaction and serum sickness following administration of crotalidae polyvalent immune fab antivenom: A meta-analysis. Acad Emerg Med. 2012;19:121-131. 3. Ruha AM, Kleinschmidt KC, Greene S, et al. The epidemiology, clinical course, and management of snakebites in the North American Snakebite Registry. J Med Toxicol. 2017;13(4):309-320. 4. Lavonas EJ, Kokko J, Schaeffer TH, Mlynarchek SL, Bogdan GM, Dart RC. Short-term outcomes after Fab antivenom therapy for severe crotaline snakebite. Ann Emerg Med. 2011;57(2):128-137.e3.