A safety profile you can count on1
Since 2001, safety data have been collected on CroFab® Crotalidae Polyvalent Immune Fab (Ovine) in the treatment of North American pit viper envenomation.
In a recent meta-analysis, the incidence of immediate hypersensitivity reactions and serum sickness was 8% (95% CI = 5% to 11%) and 13% (95% CI = 7% to 21%), respectively.*
- Sensitivity analysis excluding 2 premarketing trials, one with potential Fc contamination, reduced the estimated serum sickness to 8% (95% CI = 4% to 16%)
- To learn more, see Important Safety Information
*Meta-analysis of CroFab® studies from January 1997 (prior to FDA approval in 2000) to September 2010.
Incidence of clinical adverse events in studies of CroFab®
||Number of events (N=42)*
|Body as a whole
||8 Back pain (2), chest pain (1), cellulitis (1), wound infection (1), chills (1), allergic reactions† (1), serum sickness (1)
|Skin and appendages
||16 Urticaria (7), rash (5), pruritus (3), subcutaneous nodule (1)
||3 Asthma (1), cough (1), increased sputum (1)
||4 Nausea (3), anorexia (1)
||4 Coagulation disorder (3), ecchymosis (1)
||3 Circumoral paresthesia (1), general paresthesia (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)
*Of the 42 patients receiving CroFab® in the clinical studies, 25 experienced an adverse event. A total of 40 adverse events were experienced by these 25 patients.
‡ Six of 42 patients experienced an adverse event associated with an early serum reaction, and 4 experienced an adverse event associated with a late serum reaction. Two additional patients were considered to have a late serum reaction by the investigator, although no associated adverse event was reported.
†Allergic reactions consisted of urticaria, dyspnea, and wheezing in 1 patient.
§Serum sickness consisted of severe rash and pruritus in 1 patient.
A retrospective study of postmarketing use of CroFab® reported 36 immediate adverse drug reactions in 6.1% (15/247) of patients, including:
- 11 immediate serious adverse events 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 events 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
In a nonconcurrent, observational, cohort study of 93 patients with North American rattlesnake bites treated with CroFab®: 5 patients (5%) had acute hypersensitivity reactions, 4 (4%) developed a mild, easily treated reaction and could finish the full course of antivenom, and only 1 patient developed a reaction that prevented further antivenom administration.10
||TO REPORT AN ADVERSE EVENT OR FOR 24-HOUR MEDICAL INFORMATION, CALL 1-844-293-0007.