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abatacept

Orencia · ATC code L04AA24

Key facts
Active substance
abatacept
Drug class
Immunosuppressive drug
ATC code
L04AA24
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ORENCIA 250 mg powder for concentrate for solution for infusion · ORENCIA 50 mg solution for injection in pre-filled syringe / ORENCIA 87.5 mg solution for injection in pre-filled syringe / ORENCIA 125 mg solution for injection in pre-filled syringe · ORENCIA 125 mg solution for injection in pre-filled pen
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-27

Key facts

Abatacept is a selective modulator of T-cell co-stimulation (immunosuppressant). It is used in rheumatoid arthritis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis.

What it is used for

  • Moderate to severe active rheumatoid arthritis in adults with inadequate response to DMARDs including methotrexate or a TNF-alpha inhibitor, in combination with methotrexate
  • Highly active and progressive rheumatoid arthritis in adults not previously treated with methotrexate, in combination with methotrexate
  • Active psoriatic arthritis in adults after inadequate response to DMARDs, alone or with methotrexate
  • Polyarticular juvenile idiopathic arthritis: intravenous from 6 years, subcutaneous (pre-filled syringe) from 2 years

Dosing

  • Intravenous (250 mg powder), RA and PsA in adults: 30-minute infusion by body weight – 500 mg (< 60 kg), 750 mg (60–100 kg), 1,000 mg (> 100 kg); repeated at 2 and 4 weeks, then every 4 weeks
  • Intravenous in pJIA (6 to 17 years, under 75 kg): 10 mg/kg; 75 kg or more: adult regimen, maximum 1,000 mg
  • Subcutaneous (syringe/pen), RA: 125 mg once weekly regardless of weight, with or without an intravenous loading dose
  • Subcutaneous in PsA: 125 mg weekly without a loading dose
  • Subcutaneous in pJIA (2 to 17 years), weekly by weight: 50 mg (10 to less than 25 kg), 87.5 mg (25 to less than 50 kg), 125 mg (50 kg or more)
  • If no response within 6 months, continuation should be reconsidered; no dose recommendations in renal or hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Severe and uncontrolled infections such as sepsis and opportunistic infections

Important warnings

  • Combination with TNF inhibitors is not recommended (more infections and serious infections)
  • Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life-threatening; discontinue immediately and permanently
  • Effects on the immune system: may affect host defences against infections and malignancies, and vaccination responses
  • Monitor for signs of infection when transitioning from a TNF inhibitor

Side effects

  • Very common: upper respiratory tract infection (including tracheitis, nasopharyngitis, sinusitis)
  • Most frequently reported: headache, nausea, upper respiratory tract infections
  • Allergic reactions reported uncommonly; serious infections possible

Interactions

  • TNF inhibitors: more infections and serious infections; concurrent use not recommended
  • Methotrexate, NSAIDs and corticosteroids did not affect abatacept clearance
  • Other immune-modifying medicines and vaccinations: see full text

Pregnancy and breastfeeding

  • No adequate data in pregnant women; should not be used unless the woman's clinical condition requires it
  • Women of childbearing potential must use effective contraception during treatment and up to 14 weeks after the last dose

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)

  • OrenciaBristol-Myers Squibb Pharma EEIG · EMEA/H/C/000701

Source: European Medicines Agency (EMA), product information

Turkey

  • OrenciaBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 2 register entries

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

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

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.

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Sources

  1. European Medicines Agency. Orencia – 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/orencia-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 L04AA.

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.