Europeiska kommissionen har godkänt BIMZELX® (bimekizumab) för behandling av måttlig till svår hidradenitis suppurativa

BIMZELX® ▼ (bimekizumab) - viktig säkerhetsinformation

De vanligast rapporterade biverkningarna av bimekizumab var övre luftvägsinfektioner (14,5 % vid plackpsoriasis, 14,6 % vid psoriasisartrit, 16,3 % vid axial spondylartrit (axSpA) och 8,8 % vid hidradenitis suppurativa) och candidainfektion i munnen (7,3 % vid plackpsoriasis, 2,3 % vid psoriasisartrit, 3,7 % vid axial spondylartrit och 5,6 % vid HS). Vanligt förekommande biverkningar (≥1/100 till <1/10) var candidainfektion i munnen, svampinfektioner, öroninfektioner, herpes simplex-infektioner, oropharyngeal candida, gastroenterit, follikulit, svampinfektion i slidan (inklusive vulvovaginal candida), huvudvärk, utslag, dermatit och eksem, akne, reaktioner på injektionsstället, trötthet. Äldre löper större risk att uppleva vissa biverkningar såsom svampinfektioner i munnen, dermatit och eksem vid användning av bimekizumab.

Bimekizumab är kontraindicerat hos patienter med överkänslighet mot den aktiva substansen eller något hjälpämne och hos patienter med kliniskt betydelsefulla aktiva infektioner (t.ex. aktiv tuberkulos).

Bimekizumab kan öka risken för infektioner. Behandling med bimekizumab får inte ges till patienter med någon kliniskt viktig aktiv infektion. Patienter som behandlas med bimekizumab ska instrueras att söka medicinsk rådgivning om det uppstår tecken eller symtom på infektion. Om en patient utvecklar en infektion ska patienten övervakas noggrant. Om infektionen blir allvarlig eller inte svarar på traditionell terapi ska behandlingen med bimekizumab avbrytas tills infektionen läkt ut. Innan behandling med bimekizumab påbörjas bör patienten undersökas med avseende på tuberkulosinfektion (TB). Bimekizumab ska inte ges till patienter med aktiv TB. Patienter som får bimekizumab bör övervakas avseende tecken och symtom på aktiv TB.

Allvarliga överkänslighetsreaktioner, inklusive anafylaktiska reaktioner, har observerats med IL-17-hämmare. Om en allvarlig överkänslighetsreaktion inträffar ska administrering av bimekizumab sättas ut omedelbart och lämplig behandling påbörjas.

Levande vacciner ska inte ges till patienter som behandlas med bimekizumab.

För mer information om bimekizumab, se fullständig produktresumé: www.fass.se

Revisionsdatum för europeisk produktresumé: April 2024. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product- information_en.pdf

• Detta läkemedel är föremål för utökad övervakning. Detta kommer att göra det möjligt att snabbt identifiera ny säkerhetsinformation. Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning.

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För ytterligare information kontakta:

Nathalie Holmén, medicinsk chef immunologi UCB ABN, Alperna, Benelux och Norden, Head of Medical Immunology ABN region, nathalie.holmen@ucb.com, 070-965 54 91

Patric Berling, vd UCB Sverige, patric.berling@ucb.com, 070-552 90 98

Referenser

1. BIMZELX^® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf April 2024.

2. Jemec GB. Clinical practice: hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-64.

3. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.

4. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991–1001