- The majority of adverse reactions to CroFab (crotalidae polyvalent immune fab ovine) reported in clinical studies were mild or moderate in severity.
- The most common adverse events reported in the clinical studies were urticaria and rash. Adverse events involving the skin and appendages (primarily rash, urticaria, and pruritus) were reported in 14 of the 42 patients (Table 6).
- Of the 25 patients who experienced adverse reactions, 3 patients experienced severe or serious adverse reactions. The 1 patient who experienced a serious adverse event had a recurrent coagulopathy due to envenomation, which required re-hospitalization and additional antivenin administration. This patient eventually made a complete recovery. The other 2 had severe adverse reactions that consisted of 1 patient who developed severe hives following treatment and 1 patient who developed a severe rash and pruritus several days following treatment. Both patients recovered following treatment with antihistamines and prednisone.
- One patient discontinued CroFab (crotalidae polyvalent immune fab ovine) therapy due to an allergic reaction.
Table 6. Incidence of Clinical Adverse Events in Studies of CroFab (crotalidae polyvalent immune fab ovine) by Body System
Number of Events
|Body as a Whole|
|Skin and Appendages|
|*Of the 42 patients receiving CroFab (crotalidae polyvalent immune fab ovine) in the clinical studies, 25 experienced an adverse event. A total of 40 adverse events was experienced by these 25 patients.
†Allergic reaction consisted of urticaria, dyspnea and wheezing in 1 patient.
In the 42 patients treated with CroFab (crotalidae polyvalent immune fab ovine) for minimal or moderate crotalid envenomations, there were 7 events classified as early serum reactions and 5 events classified as late serum reactions, and none were serious (Table 7). In the clinical studies, serum reactions consisted mainly of urticaria and rash, and all patients recovered without sequelae.
Table 7. Incidence of Early and Late Serum Reactions (Reactions Associated with CroFab (crotalidae polyvalent immune fab ovine) Infusion)
Number of Events
|Early Serum Reactions|
|Late Serum Reactions|
|*6 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 reaction consisted of urticaria, dyspnea and wheezing in 1 patient.
†Serum sickness consisted of severe rash and pruritus in 1 patient.