HEPZATO KIT™ Risk Evaluation and Mitigation Strategy (REMS)
What Is the HEPZATO KITTM REMS?
A risk evaluation and mitigation strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the US Food and Drug Administration (FDA).
The FDA has determined that a REMS is necessary to ensure that the benefits of HEPZATO KIT outweigh the risks of severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events associated with HEPZATO KIT.
Healthcare Settings must be certified in the HEPZATO KIT REMS in order to dispense HEPZATO KIT.
Please see the HEPZATO KIT prescribing information for more information, including complete boxed warning.
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