Safety | Novartis Egypt

Cosentyx 150 mg provided a favorable and consistent safety profile through 5 years of treatment in patients with AS.²

Adapted from reference 3

Safety and experience

Uncommon and easily managed Candida infections³
No increase in incidence of IBD (UC and CD) over time³
No new safety signals, across any indication. ³
Less than 1% immunogenicity⁴

Cosentyx is not recommended for patients with Inflammatory bowel disease.⁴

Cosentyx API

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Footnotes:

*Rates for system organ class.
†Rates for high-level terms.
‡ Opportunistic infections were bronchopulmonary aspergillosis, cytomegalovirus gastroenteritis, gastrointestinal candidiasis, herpes zoster cutaneous disseminated, herpes zoster infection neurological, Mycobacterium avium complex infection, esophageal candidiasis, Pneumocystis jirovecii pneumonia, toxoplasmosis, tuberculosis.
§Rates for preferred terms.
|| Rates for Novartis MedDRA Query terms.
¶Rates for standardized MedDRA Query terms—“malignancies and unspecified tumor.”
AS=ankylosing spondylitis; AEs=adverse events; EAIR=exposure-adjusted incidence rate; IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; PY=patient-years; MedDRA=Medical Dictionary for Regulatory Activities; CD=Crohn’s disease; IBD=inflammatory bowel disease; UC=ulcerative colitis.

References

Egyptian Drug Authority (EDA) Cosentyx 150,300 mg leaflet approval date: 23/03/2025.
Baraliakos X, Braun J, Deodhar A, Poddubnyy D, Kivitz A, Tahir H, Van den Bosch F, Delicha EM, Talloczy Z, Fierlinger A. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD open. 2019 Sep 1;5(2):e001005.
Gottlieb AB, Deodhar A, Mcinnes IB, Baraliakos X, Reich K, Schreiber S, Bao W, Marfo K, Richards HB, Pricop L, Shete A. Long-term safety of secukinumab over five years in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis: update on integrated pooled clinical trial and post-marketing surveillance data. Acta Dermato Venereologica. 2022 Apr 27;102.
Cosentyx Summary of Products characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf, Last Accessed: 18/06/2025. Last updated: 10/07/2023.
EMA Cosentyx Overview. Available at :https://www.ema.europa.eu/en/documents/overview/cosentyx-epar-medicine-overview_.pdf, Last Accessed: 18/06/2025. Last Updated :03/06/2023.

Approved by Egyptian Drug Authority:BF0424OA4792/092025. Invalidation date: 06/12/2026.
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