Efficacy

CroFab® is Proven to Control Envenomation in Pediatric and Adult Patients

Gaining Initial Control with CroFab®

In two open-label trials with 42 patients with mild or moderate envenomation1,2*:

  • 98% of patients administered CroFab® gained initial control1,2
  • 95% of patients showed a clinical response 1 hour after initial control1,2
 

*This study excluded envenomation by copperhead snakes. In study 1, patients were given up to 2 doses of 4 vials each to gain initial control. In study 2, patients were given up to 6 vials each to gain initial control. Initial control is achieved when local signs of envenomation are arrested (leading edge of local injury is not progressing), systemic symptoms are resolved, and coagulation parameters have normalized or are trending toward normal.

Clinical response = pretreatment signs and symptoms of envenomation were arrested or improved


Demonstrated efficacy in gaining initial control

In a placebo-controlled trial of 74 patients with copperhead envenomation published in 2017, CroFab® administration resulted in improved limb function vs. placebo on Day 14 post envenomation.3

Trial data was drawn specifically from patients suffering from mild or moderate copperhead snake envenomation.

Continuing Control with CroFab®

Scheduled maintenance dosing after initial control lowered incidence of coagulation abnormalities due to residual venom.1

Fewer coagulation abnormalities with scheduled maintenance dosing1

Chart demonstrating fewer abnormalities with scheduled maintenance dosing

No local progression with scheduled maintenance dosing4

Chart demonstrating no logical progression with scheduled maintenance dosing

§P=0.04.
||Not statistically significant vs. placebo.
Follow-up data not available for 1 patient.
P=0.002.

Review the safety profile you can count on.

References:

1. CroFab® [prescribing Information]. BTG International Inc; May 2017. 2. Data on file. Conshohocken, PA; BTG International Inc. 2015. 3. Gerardo CJ, Quackenbush E, Lewis B, et al. The efficacy of crotalidae polyvalent immune fab (ovine) antivenom versus placebo plus optional rescue therapy on recovery from copperhead snake envenomation: A randomized, double-blind, placebo-controlled clinical trial. Ann Emerg Med. 2017; 70(2):233-244. 4. Dart RC, Seifert SA, Boyer LV, et al. A randomized multicenter trial of crotalinae polyvalent immune Fab (ovine) antivenom for the treatment for crotaline snakebite in the United States. Arch Intern Med. 2001;161(16):2030-2036.