A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh the risks.
In order for Janseen Biotech, Inc., to communicate certain risks about STELARA®, we have worked with the FDA to develop materials to communicate the potential risks of:
- serious infections,
- and reversible posterior leukoencephalopathy syndrome (RPLS)
associated with STELARA®