5PSQ-103 Extravasation and oncohaematological biological drugs: analysis of reports in the national Italian pharmacovigilance network

<h3>Background and Importance</h3> Extravasation, the unintended leakage of intravenous drugs into surrounding tissues, can cause serious complications, especially with antineoplastic and biological therapies, with an incidence of 0.1% to 6% in chemotherapy patients.¹ Current guidelines² often overlook extravasation management for new biological agents, highlighting the need for updated protocols and education. Hospital pharmacists play a key role in assessing risks and providing antidote information, using data sheets, guidelines, literature, and the National Pharmacovigilance Network (RNF).³ <h3>Aim and Objectives</h3> The study aimed to analyse pharmacovigilance data to better understand extravasation as an adverse event in oncohaematological treatments, focusing on new biological drugs. <h3>Material and Methods</h3> Data were extracted from the RNF through August 2024. Reports included data coded with a Lowest Level Term (LLT) linked to ‘extravasation’ and classified as suspected adverse reactions associated with drugs according to the Anatomical Therapeutic Chemical (ATC) classification ’L- Antineoplastic and Immunomodulating Agents.’ Qualitative and quantitative analyses were conducted, focusing on LLTs for each active substance, particularly biological drugs.The data sheets of the biological agents were reviewed to assess whether they included instructions or recommendations for managing extravasation. <h3>Results</h3> A total of 344 reports were analysed, including 887 LLTs. The analysis included 41 active substances, including 12 biological drugs, representing 7% of the total LLTs. There were 23 reports involving biological drugs, accounting for 60 LLTs. Serious LLTs were noted in 134 cases, associated with 28 active substances, including four biological drugs. Reactions to biological agents included pain, swelling, and irritation. Notably, one report of durvalumab extravasation documented serious LLTs such as hyperbilirubinaemiaand neutropenia. <h3>Conclusion and Relevance</h3> In conclusion, extravasation-related adverse events associated with biological drugs are occurring but may be underreported due to misclassification as general incidents. Notably, only 2 of the 12 biological agents analysed included specific references to extravasation in their data sheets. Improving the recognition and reporting of extravasation through clearer guidelines may promote patient safety and clinical outcomes. <h3>References and/or Acknowledgements</h3> Kreidieh Firas Y, <i>et al</i>. Overview, prevention and management of chemotherapy extravasation. <i>World J Clin Oncol</i>. 2016;<b>7</b>(1):87–97 Pérez Fidalgo JA, <i>et al</i>. Management of chemotherapy extravasation: ESMO-EONS clinical practice guidelines. <i>Ann Oncol</i>. 2012;<b>23</b>(Suppl 7):VIIi167–73 www.statements.eahp.eu/statements/final-statements.(5.4;5.9) <h3>Conflict of Interest</h3> No conflict of interest