Two decades of pharmacovigilance and clinical experience with highly purified rabies immunoglobulin F(ab')2fragments.
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')2fragments from equine rabies immunoglobulin (F(ab')2pERIG; FavirabTM) 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')2pERIG, 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')2pERIG 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')2pERIG (FavirabTM) in rabies PEP.
a Sanofi Pasteur , Lyon , France.
Elisa
E
Reveneau
a Sanofi Pasteur , Lyon , France.
Pascale
P
Cottin
a Sanofi Pasteur , Lyon , France.
Anvar
A
Rasuli
D000707:Anaphylaxis / Q000209:etiology; D000818:Animals; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D060735:Pharmacovigilance; D056990:Post-Exposure Prophylaxis; D011358:Product Surveillance, Postmarketing; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D012189:Retrospective Studies
D007140:Immunoglobulin Fab Fragments; D011819:Rabies Vaccines
Rabies; immunization; immunoglobulin; post-exposure prophylaxis; vaccine