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bimekizumab

Bimzelx · ATC code L04AC21

Key facts
Active substance
bimekizumab
Drug class
Immunosuppressive drug
ATC code
L04AC21
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Bimzelx 160 mg solution for injection in pre-filled syringe / Bimzelx 320 mg solution for injection in pre-filled syringe / Bimzelx 160 mg solution for injection in pre-filled pen
Marketing authorisation holder
UCB Pharma S.A.
Information as of
2026-10-27

Key facts

Bimekizumab is a monoclonal antibody that inhibits IL-17A and IL-17F. It is used in adults with plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and hidradenitis suppurativa.

What it is used for

  • Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
  • Active psoriatic arthritis after inadequate response to DMARDs, alone or with methotrexate
  • Active non-radiographic axial spondyloarthritis and ankylosing spondylitis
  • Active moderate to severe hidradenitis suppurativa after inadequate response to conventional systemic therapy

Dosing

  • Plaque psoriasis: 320 mg subcutaneously at week 0, 4, 8, 12, 16 and every 8 weeks thereafter.
  • Psoriatic arthritis and axial spondyloarthritis: 160 mg every 4 weeks; with coexistent moderate to severe psoriasis, as for plaque psoriasis.
  • Hidradenitis suppurativa: 320 mg every 2 weeks up to week 16, then every 4 weeks.
  • Psoriasis with body weight ≥120 kg and incomplete clearance at week 16: 320 mg every 4 weeks may improve response.
  • Consider stopping if no improvement by 16 weeks; no adjustment for elderly or renal/hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Clinically important active infections, e.g. active tuberculosis

Important warnings

  • Increased risk of infections (e.g. upper respiratory tract infections, oral candidiasis); interrupt if infection becomes serious
  • Evaluate for tuberculosis before treatment; do not give in active TB
  • Caution in chronic or recurrent infection
  • Record the batch number for traceability

Side effects

  • Very common: upper respiratory tract infections
  • Common: oral candidiasis, tinea infections, ear infections, herpes simplex infections
  • Common: oropharyngeal candidiasis, gastroenteritis, folliculitis

Interactions

  • No interaction studies have been performed
  • CYP450 levels may normalise; consider monitoring with narrow-therapeutic-index CYP450 substrates (e.g. warfarin)

Pregnancy and breastfeeding

  • Women of childbearing potential: effective contraception during treatment and for at least 17 weeks after.
  • Limited data in pregnancy; as a precaution, use is preferably avoided.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • BimzelxUCB Pharma S.A. · EMEA/H/C/005316

Source: European Medicines Agency (EMA), product information

Turkey

  • BimzelxUCB PHARMA A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Bimzelx
Liechtenstein
Bimzelx
Norway
Bimzelx

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Bimzelx – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AC.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.