Two decades of pharmacovigilance and clinical experience with highly purified rabies immunoglobulin F(ab')₂ fragments

ABSTRACT

Introduction: Rabies is a worldwide zoonotic viral disease with no specific treatment once symptoms occur; manifest disease is almost always fatal. WHO recommendations for exposed individuals include immediate attention to the wound and use of rabies immunoglobulin and/or vaccine for post-exposure prophylaxis (PEP). Here, we provide an overview of the clinical experience with a highly purified preparation of F(ab’)₂ fragments from equine rabies immunoglobulin (F(ab’)₂ pERIG; Favirab^TM) in rabies PEP.

Areas covered: Our review comprises a retrospective analysis of adverse event reports in the Sanofi Pasteur global pharmacovigilance database for F(ab’)₂ pERIG, including adverse event reports from eight Sanofi Pasteur-sponsored clinical trials and post-market surveillance data collected between 1995 and 2014. The general safety profile of F(ab’)₂ pERIG is discussed, as are the occurrence of rare anaphylactic reactions, and suspected intervention failure.

Expert commentary: Over 20 years of clinical development and post-licensure experience has established the safety and effectiveness of F(ab’)₂ pERIG (Favirab^TM) in rabies PEP.

KEYWORDS:

• Rabies
• immunoglobulin
• vaccine
• immunization
• post-exposure prophylaxis

Acknowledgements

The authors thank Jean-Sébastien Persico for critical review of the manuscript.

Declaration of interest

E Reveneau, P Cottin and A Rasuli are all employees of Sanofi Pasteur. Editorial assistance with the preparation of this paper was provided to the authors by Richard Glover of inScience Communications, Springer Healthcare. Funding for this assistance was provided by Sanofi Pasteur. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Notes

1. Category I: touching or feeding animals, licks on intact skin, contact of intact skin with secretions or excretions of a rabid animal or human. Category II: nibbling of uncovered skin, minor scratches or abrasions without bleeding. Category III: single or multiple transdermal bites or scratches, licks on broken skin, contamination of mucous membrane with saliva from licks and exposure to bats.

Additional information

Funding

This paper was funded by Sanofi Pasteur.