{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T19:29:58Z","timestamp":1787772598089,"version":"build-2784847793"},"reference-count":13,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>TwinRab\u2122 is a novel life-saving biological containing two monoclonal antibodies (docaravimab and miromavimab) essential for all age victims of category III animal exposures. It effectively neutralizes rabies and similar viruses at the exposure site until the body generates vaccine-induced antibodies. This postmarketing surveillance study assesses the safety of TwinRab\u2122 in current postexposure prophylaxis (PEP) use and aims to reinforce its safety data for future applications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The prospective, open-label observational study was conducted on patients with the World Health Organization category III animal exposures at a government hospital in a northern region of India, by a suspected rabid animal. The study protocol included administering TwinRab\u2122 (40 IU\/kg) and a full course of anti-rabies vaccination as PEP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Out of 405 participants, 404 completed the study as per the protocol. Adverse events (AEs) occurred in 12.35% of cases, with 9.88% local AEs (primarily pain and tenderness) and 2.47% systemic AEs (fever, malaise, and myalgia). All AEs were mild and resolved without complications. Most participants (88.9%) and investigators (89.1%) rated TwinRab\u2122\u2019s tolerability as excellent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The present study demonstrates the evidence of a satisfactory safety profile along with better tolerability of TwinRab\u2122 (40 IU\/kg) for category III animal exposures and supports its continued usage.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/ijabmr.ijabmr_281_24","type":"journal-article","created":{"date-parts":[[2024,8,24]],"date-time":"2024-08-24T09:00:54Z","timestamp":1724490054000},"page":"193-198","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":1,"title":["Assessing the Safety of a Novel Monoclonal Antibody Cocktail for Postexposure Prophylaxis in Category III Animal Exposures"],"prefix":"10.4103","volume":"14","author":[{"given":"Amandev","family":"Singh","sequence":"first","affiliation":[{"name":"Department of Community Medicine, Government Medical College, Patiala, Punjab, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raminderpal Singh","family":"Sibia","sequence":"additional","affiliation":[{"name":"Department of Medicine, Government Medical College, Patiala, Punjab, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simmi","family":"Oberoi","sequence":"additional","affiliation":[{"name":"Department of Community Medicine, Government Medical College, Patiala, Punjab, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lovleen","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Department of Medicine, Government Medical College, Patiala, Punjab, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sachin","family":"Kaushal","sequence":"additional","affiliation":[{"name":"Department of Medicine, Government Medical College, Patiala, Punjab, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trayambak","family":"Dutta","sequence":"additional","affiliation":[{"name":"Zydus Lifesciences Limited, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manish","family":"Mahajan","sequence":"additional","affiliation":[{"name":"Zydus Lifesciences Limited, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir","family":"Desai","sequence":"additional","affiliation":[{"name":"Zydus Lifesciences Limited, Ahmedabad, Gujarat, 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mutans","volume":"31","author":"Kr\u00fcger","year":"2005","journal-title":"Mol Biotechnol"},{"key":"R11-20240902","doi-asserted-by":"crossref","first-page":"e2722","DOI":"10.1093\/cid\/ciaa779","article-title":"Aphase 3, randomized, open-label, noninferiority trial evaluating anti-rabies monoclonal antibody cocktail (TwinrabTM) against human rabies immunoglobulin (HRIG)","volume":"73","author":"Kansagra","year":"2021","journal-title":"Clin Infect Dis"},{"key":"R12-20240902","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1093\/cid\/cix791","article-title":"Comparison of a novel human rabies monoclonal antibody to human rabies immunoglobulin for postexposure prophylaxis:A phase 2\/3, randomized, single-blind, noninferiority, controlled study","volume":"66","author":"Gogtay","year":"2018","journal-title":"Clin Infect Dis"},{"key":"R13-20240902","first-page":"e52163","article-title":"Real-world safety of TwinRab, the world's first novel cocktail of rabies monoclonal antibodies, in a clinical setting","volume":"16","author":"Manna","year":"2024","journal-title":"Cureus"},{"key":"R14-20240902","doi-asserted-by":"crossref","first-page":"443","DOI":"10.4103\/ijcm.ijcm_562_23","article-title":"Post-marketing surveillance of the world's first novel cocktail of rabies monoclonal antibodies:TwinRab\u2122in real \\-world setting","volume":"49","author":"Tambe","year":"2024","journal-title":"Indian J Community Med"}],"container-title":["International Journal of Applied &amp; Basic Medical 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