† The majority of adverse reactions to CroFab 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 therapy due to an allergic reaction.

In the 42 patients treated with CroFab 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.

Studies of drug interactions have not been conducted with CroFab.

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