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certolizumab pegol

Cimzia · ATC code L04AB05

Also known as: Sertolizumab pegol

Key facts
Active substance
certolizumab pegol
Drug class
Immunosuppressive drug
ATC code
L04AB05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Cimzia 200 mg solution for injection in pre-filled syringe · Cimzia 200 mg solution for injection in pre-filled pen
Marketing authorisation holder
UCB Pharma
Information as of
2026-10-28

Key facts

Certolizumab pegol (Cimzia) is a pegylated TNF-alpha inhibitor given by subcutaneous injection. It is used in adults with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and plaque psoriasis.

What it is used for

  • Moderate to severe active rheumatoid arthritis with inadequate response to DMARDs (with methotrexate, or as monotherapy if MTX is not tolerated), and severe, active, progressive RA not previously treated with MTX.
  • Severe active axial spondyloarthritis (ankylosing spondylitis and non-radiographic form) with inadequate response to or intolerance of NSAIDs.
  • Active psoriatic arthritis after inadequate response to DMARDs.
  • Moderate to severe plaque psoriasis in candidates for systemic therapy.

Dosing

  • Loading dose for all indications: 400 mg (2 injections of 200 mg) subcutaneously at weeks 0, 2 and 4.
  • Maintenance in rheumatoid and psoriatic arthritis: 200 mg every 2 weeks; once response is confirmed, 400 mg every 4 weeks can be considered.
  • Axial spondyloarthritis: 200 mg every 2 weeks or 400 mg every 4 weeks; after at least 1 year in sustained remission, 200 mg every 4 weeks may be considered.
  • Plaque psoriasis: 200 mg every 2 weeks; 400 mg every 2 weeks can be considered with insufficient response.
  • Should not be used in children and adolescents below 18 years.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Active tuberculosis or other severe infections such as sepsis or opportunistic infections.
  • Moderate to severe heart failure (NYHA classes III/IV).

Important warnings

  • Monitor for infections including tuberculosis before, during and for up to 5 months after treatment; do not start during an active infection.
  • Hepatitis B reactivation, sometimes fatal; test for HBV before starting.
  • A possible risk of lymphoma, leukaemia and other malignancies cannot be excluded.
  • Rare cases of demyelinating disease have been reported.
  • Live vaccines should not be given concurrently.

Side effects

  • Common: bacterial infections (including abscess) and viral infections (including herpes zoster, papillomavirus, influenza).
  • Uncommon: sepsis, tuberculosis, fungal infections, blood and lymphatic malignancies and non-melanoma skin cancers.
  • Severe hypersensitivity reactions have been reported rarely.

Interactions

  • Combination with anakinra or abatacept is not recommended.
  • Methotrexate, corticosteroids, NSAIDs and analgesics do not affect its pharmacokinetics.
  • Live vaccines should not be administered concurrently.

Pregnancy and breastfeeding

  • Data from more than 1500 pregnancies exposed in the first trimester indicate no malformative or feto/neonatal toxicity.
  • If Cimzia is to be cleared before conception, continue contraception for 5 months after the last dose.

Summary of the official product information, written with AI on 2026-10-29. 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

This product has no separate US patient information.

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)

  • CimziaUCB Pharma · EMEA/H/C/001037

Source: European Medicines Agency (EMA), product information

Turkey

  • CimziaUCB 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
Cimzia
Liechtenstein
Cimzia
Norway
Cimzia

EMA – Article 57 product data (EU/EEA), 2026-10-29

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. Cimzia – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/cimzia-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 L04AB.

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.