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Risk evaluation and mitigation strategies: a focus on belatacept
Teena Sam1, Steven Gabardi, Eric M Tichy
1Yale-New Haven Hospital, New Haven, CT, USA. teena.sam@ynhh.org
Progress in Transplantation (Aliso Viejo, Calif.)
|March 2, 2013
Summary
Belatacept (a costimulation blocker) has a Risk Evaluation and Mitigation Strategy (REMS) to manage risks like infections and PTLD. Healthcare providers must understand belatacept REMS for safe transplant recipient care.
Area of Science:
- Transplantation medicine
- Immunosuppression
- Pharmacovigilance
Background:
- Belatacept is a novel costimulation blocker used for maintenance immunosuppression in organ transplantation.
- While offering superior renal function compared to cyclosporine in trials, belatacept carries risks including posttransplant lymphoproliferative disorder (PTLD) and CNS infections.
Purpose of the Study:
- To review the components of the Risk Evaluation and Mitigation Strategies (REMS) for belatacept.
- To outline the implications of belatacept REMS for healthcare providers managing transplant recipients.
Main Methods:
- Literature search of MEDLINE and EMBASE databases (1990-2012) using terms: risk evaluation and mitigation strategies, REMS, belatacept, organ transplant.
- Supplemented with information from the Federal Register, FDA, and belatacept manufacturer.
Main Results:
- REMS are designed to ensure a medication's benefits outweigh its risks.
- Belatacept's REMS program was mandated by the FDA due to increased risks of PTLD and CNS infections.
- The REMS program aims to optimize belatacept's risk-benefit profile through safe and appropriate use.
Conclusions:
- Belatacept REMS include a medication guide and a communication plan.
- Healthcare providers and patients must recognize belatacept's potential risks for effective management.
- The REMS facilitates careful patient selection, education, and vigilant monitoring.
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