A safety profile on idarucizumab for dabigatran reversal: an update

INTRODUCTION: Idarucizumab has been widely adopted since its approval as the only reversal agent for dabigatran. Since then, evidence on its effectiveness, safety, and real-world use has continued to accumulate. AREAS COVERED: This review summarizes the pharmacological characteristics of idarucizumab, the clinical evidence supporting its use, and practical considerations for administration, including post-reversal care. We also provide expert opinion on its role as reversal agent. Key literature on clinical evidence, pharmacology, and safety was identified through PubMed searches and screening of reference lists. EXPERT OPINION: Idarucizumab remains the only approved targeted antidote for dabigatran and is likely to retain this position in the near term. However, evidence for clinical benefit remains limited to observational data and a single-arm trial conducted without a comparator. High cost and lower dabigatran use compared with other DOACs may make routine stocking of idarucizumab impractical in rural or resource-limited settings. In our expert opinion, its indication can be complex, particularly because trial-based bleeding definitions may not align with clinical practice; therefore, multidisciplinary input may be required to support appropriate use. Furthermore, we advocate that multidisciplinary care should extend beyond hemostasis is achieved, dedicated aftercare and anticoagulation stewardship could optimize clinical outcomes.