Serious allergic reactions have been reported in the post-marketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious allergic reaction occurs, administration of STELARA should be discontinued immediately and appropriate treatment instituted.
It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and GuÉrin [BCG]) should not be given concurrently with STELARA.
No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Special Warnings and Precautions for Use
Concomitant immunosuppressive therapy: Caution should be exercised when considering concomitant use of other immunosuppressants and ustekinumab or when transitioning from other immunosuppressive biologics.
For complete EU prescribing information, please visit http://www.emea.europa.eu.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
1) Augustin M, Herberger K, Hintzen S, Heigel H, Franzke N, ShÄfer I. Prevalence of skin lesions and need for treatment in a cohort of 90880 workers. Br
J Dermatol. 2011;165(4):865-873. 2) Parisi R, Symmons DP, Griffiths CE, Ashcroft DM, on behalf of the Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377-385. 3) Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004;14:41-45. 4) About Psoriasis: Statistics. National Psoriasis Foundation. http://www.psoriasis.org/learn_statistics. Accessed September 10, 2013. 5) About Psoriatic Arthritis. National Psoriasis Foundation. http://www.psoriasis.org/psoriatic-arthritis , Accessed September 102013. 6) FitzGerald O, Winchester R. Psoriatic arthritis: from pathogenesis to therapy. Arthritis Res Ther 2009;11(1):214. 7) Chandran V, Raychaudhuri SP. Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis. J Autoimmun 2010;34(3):J314-321. 8) Amherd-Hoekstra A, NÄher H, Lorenz H-M, Enk AH. Psoriatic arthritis: a review. JDDG 2010;8(5):332-339. 9) Stelara Summary of Product Characteristics, September 2013.
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