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,
  • malignancy,
  • and reversible posterior leukoencephalopathy syndrome (RPLS)

associated with STELARA®


These highlights do not include all the information needed to use STELARA® safely and effectively. See full Prescribing Information for STELARA®.


Clinically significant hypersensitivity to ustekinumab or to any of the excipients.


  • Infections: Serious infections have occurred. Do not start STELARA® during any clinically important active infection. If a serious infection develops, stop STELARA® until the infection resolves. (see Section 5.1 of the Prescribing Information)
  • Theoretical Risk for Particular Infections: Serious infections from mycobacteria, Salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Diagnostic tests for these infections should be considered as dictated by clinical circumstances. (See Section 5.2 of the Prescribing Information)
  • Tuberculosis (TB) evaluation: Evaluate patients for TB prior to initiating treatment with STELARA®. Initiate treatment of latent TB before administering STELARA®. (See Section 5.3 of the Prescribing Information)
  • Malignancies: STELARA® may increase risk of malignancy. The safety of STELARA® in patients with a history of or a known malignancy has not been evaluated. (See Section 5.4 of the prescribing Information)
  • Anaphylaxis or other clinically significant hypersensitivity reactions may occur. (See Section 5.5 of the Prescribing Information)
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): One case was reported. If suspected, threat promptly and discontinue STELARA®. (See Section 5.6 of the Prescribing Information)


Most common adverse reactions (incidence >3% and greater than with placebo): Nasopharyngitis, upper respiratory tract infection, headache, and fatigue. (See Section 6.1 of the Prescribing Information)

To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or 1-800-FDA-1088 or www.fda.gov/medwatch.


  • Live vaccines: Should not be given with STELARA®. (See Section 7.1 of the Prescribing Information)
  • Concomitant therapy in psoriasis studies: the safety of concomitant use of STELARA® with immunosuppressants or phototherapy has not been evaluated. (See Section 7.2 of the Prescribing Information)

Please see accompanying full Prescribing Information and Medication Guide for STELARA®