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U.S. Department of Health and Human Services


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Stelara (ustekinumab) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012


Summary View



6.1 Clinical Studies Experience
  • The safety data reflect exposure to STELARA in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, ......


  • Among 3117 subjects treated in 4 In the controlled and non-controlled portions of psoriasis clinical trials of STELARA (1129 subjects treated for at least 3 years, and 619 subjects for at least 4 years), (median follow up of 2.6 years, representing 6791 subject-years of exposure), 1.3% of STELARA-treated subjects reported ...
6.2 Immunogenicity
  • Table 2 .... data changed


7.4  Allergen Immunotherapy
  • STELARA has not been evaluated in patients who have undergone allergy immunotherapy. STELARA may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.