Injection site reactions of biologics and mitigation strategies

Abstract

Abstract Biological products administered via subcutaneous (SC) injections offer an effective and convenient alternative to those administered via traditional intravenous injections and have gained a significant increase among approved drugs in recent years. However, SC injections may cause injection site reactions (ISRs) especially injection site pain (ISP). Although usually mild and occurring with variable frequency ranging from about 0.8 to 15.5%, ISRs can degrade patient experience and negatively impact patient treatment adherence. In an effort to prevent unnecessary discontinuation of the treatment, this review article aims to provide an overview of the key risk factors reported in published literature that may contribute to ISRs in SC administered biologics. In addition, mitigation strategies are proposed to help reduce the incidence of ISRs, support the development of well-tolerated SC products, and allow patients to take advantage of the full value of the SC route of administration. Graphical abstract

Keywords

• Subcutaneous injection
• Biologics
• Injection site reactions
• Injection site pain
• Risk factor
• Formulation