The approval of Romiplostim (Nplate®), as well as Eltrombopag (PROMACTA®) included a mandatory Risk Evaluation and Mitigation Strategy (REMS) for the following reasons. There has been some concern raised with regards to long term risks associated with TPO receptor agonists, in particular bone marrow reticulin formation and risk for bone marrow fibrosis. These adverse events however were not noted in the phase III clinical trials. The Risk Evaluation and Mitigation Strategy is intended to ensure that the product is safely used with proper informed consent. It is therefore mandatory that all parties including the prescribers, patients, as well as institutions and pharmacies that wish to provide these drugs, register through the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) program for Romiplostim (Nplate®) and through PROMACTA® CARES for Eltrombopag (PROMACTA®) respectively. These patient registries are meant to monitor long term safety of these agents. REMS will soon be be mandated for ESA’s as well.
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