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Crotalidae polyvalent immune Fab: in patients with North American crotaline envenomation.

Abstract
Crotalidae polyvalent immune Fab is an antivenom comprising purified, sheep-derived, Fab IgG fragments and is indicated for use in patients with North American crotaline envenomation. Crotalidae polyvalent immune Fab is produced using four North American snake venoms: Crotalus atrox, Crotalus adamanteus, Crotalus scutulatus, and Agkistrodon piscivorus. Intravenous crotalidae polyvalent immune Fab was effective in patients aged ≥10 years who had minimal or moderate envenomation by a North American crotaline, who presented within 6 hours of the snakebite, and who had progression of the envenomation syndrome, according to the results of two prospective trials. One trial was a noncomparative, multicenter pilot study and the other trial was a randomized, open-label, multicenter trial in which patients received scheduled or 'as needed' administration of crotalidae polyvalent immune Fab after initial control had been achieved. A prospective, postmarketing trial demonstrated the efficacy of crotalidae polyvalent immune Fab in confirmed Crotalus viridis helleri envenomation (indicating cross-protection against a venom not used in its production). Results of these prospective trials are supported by the findings of additional (mainly retrospective) studies demonstrating the efficacy of crotalidae polyvalent immune Fab in patients with crotaline envenomation, including patients with severe envenomation, pediatric patients, and patients with symptoms of neurotoxicity. Despite treatment with crotalidae polyvalent immune Fab, patients may experience delayed-onset or recurrent venom effects (e.g. coagulopathy). Intravenous crotalidae polyvalent immune Fab was generally well tolerated; acute hypersensitivity reactions (e.g. urticaria, rash, pruritus) were the most commonly occurring adverse event.
AuthorsGillian M Keating
JournalBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (BioDrugs) Vol. 25 Issue 2 Pg. 69-76 (Apr 01 2011) ISSN: 1179-190X [Electronic] New Zealand
PMID21443271 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Review)
Copyright© 2011 Adis Data Information BV. All rights reserved.
Chemical References
  • Antivenins
  • Crotalid Venoms
  • Crotalidae Polyvalent immune Fab
  • Immunoglobulin Fab Fragments
  • Immunoglobulin Fragments
Topics
  • Animals
  • Antivenins (adverse effects, therapeutic use)
  • Crotalid Venoms (antagonists & inhibitors)
  • Crotalus
  • Humans
  • Immunoglobulin Fab Fragments
  • Immunoglobulin Fragments (adverse effects, therapeutic use)
  • Pilot Projects
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Snake Bites (therapy)
  • Treatment Outcome

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