At Janssen Biotech, Inc., we understand our responsibility to provide knowledge and resources to help ensure continuous safety monitoring and the timely identification and reporting of adverse events. We recognize the importance of education as the foundation of informed Benefit:Risk decisions and this website is dedicated to communicating important safety information about STELARA® to contribute to those decisions.

One method that the FDA can use to convey important safety information about products with known, or potential, serious risks is through a communication plan within a Risk Evaluation and Mitigation Strategy (REMS). A REMS is an overall strategy that focuses on managing risks associated with a drug or biological product.

Janssen Biotech, Inc. has worked with the FDA to develop a program to communicate important safety information about STELARA®. All biologic therapies carry with them certain risks that warrant your consideration prior to initiation of therapy. The goal of this REMS is to communicate and mitigate the risks associated with STELARA® by alerting healthcare professionals and patients about the potential risks of serious infections and malignancy, and Reversible Posterior Leukoencephalopathy Syndrome (RPLS).

Janssen Biotech, Inc. has provided information within this website to increase healthcare professionals' and patients' awareness of these risks. Please review all materials to help ensure that the most informed conversations can occur and to facilitate appropriate utilization of STELARA®.

IMPORTANT HIGHLIGHTS OF PRESCRIBING INFORMATION

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

WARNINGS AND PRECAUTIONS

  • 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)
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): One case was reported. If suspected, treat promptly and discontinue STELARA®. (See Section 5.5 of the Prescribing Information)

ADVERSE REACTIONS

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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Live vaccines: Should not be given with STELARA®. (See Section 7.1 of the Prescribing Information)
  • Concomitant therapy: 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®