adalimumab
Humira · ATC code L04AB04
- Key facts
- Active substance
- adalimumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AB04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Humira 20 mg solution for injection in pre-filled syringe · Humira 40 mg solution for injection in pre-filled syringe / Humira 40 mg solution for injection in pre-filled pen · Humira 80 mg solution for injection in pre-filled syringe / Humira 80 mg solution for injection in pre-filled pen
- Marketing authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Information as of
- 2026-10-27
Key facts
Adalimumab is a TNF-alpha-blocking monoclonal antibody used for inflammatory conditions such as rheumatoid arthritis, psoriasis and Crohn's disease.
What it is used for
- Rheumatoid arthritis in adults (usually with methotrexate)
- Polyarticular juvenile idiopathic arthritis from 2 years; enthesitis-related arthritis from 6 years
- Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis
- Plaque psoriasis in adults and in children and adolescents from 4 years
- Crohn's disease (including children from 6 years), ulcerative colitis, hidradenitis suppurativa, uveitis
Dosing
- Subcutaneous injection; initiated and supervised by experienced specialists, self-injection possible after training
- Rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis (adults): 40 mg every other week
- Rheumatoid arthritis monotherapy: with decreasing response, possibly 40 mg every week or 80 mg every other week
- Psoriasis (adults): initial 80 mg, then 40 mg every other week starting one week after the initial dose
- Children: weight-based, e.g. polyarticular JIA 10 kg to < 30 kg: 20 mg, ≥ 30 kg: 40 mg every other week
- Further schemes (Crohn's disease, ulcerative colitis, hidradenitis, uveitis) are in the full text
Contraindications
- Hypersensitivity to the active substance or any excipient
- Active tuberculosis or other severe infections such as sepsis and opportunistic infections
- Moderate to severe heart failure (NYHA class III/IV)
Important warnings
- Increased susceptibility to serious infections; monitoring including for tuberculosis before, during and after treatment
- Elimination may take up to four months, so monitoring continues throughout this period
- Treatment is not started in active infections until they are controlled
- Risk-benefit assessment after tuberculosis exposure or travel to areas with endemic mycoses
- Name and batch number recorded for traceability
Side effects
- Most common: infections (e.g. nasopharyngitis, upper respiratory tract infection, sinusitis)
- Injection site reactions (erythema, itching, haemorrhage, pain, swelling)
- Headache and musculoskeletal pain
- Serious reactions possible; TNF antagonists may affect the defence against infection and cancer
Interactions
- Without methotrexate: increased antibody formation, increased clearance and reduced efficacy
- Combination with anakinra or abatacept is not recommended
Pregnancy and breastfeeding
- Women of childbearing potential should consider contraception and continue it for at least five months after the last dose
- Approximately 2100 prospectively collected exposed pregnancies do not indicate an increased rate of malformation
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.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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)
- Amgevita · biosimilarAmgen Europe B.V. · EMEA/H/C/004212
- Amsparity · biosimilarPfizer Europe MA EEIG · EMEA/H/C/004879
- Hefiya · biosimilarSandoz GmbH · EMEA/H/C/004865
- Hukyndra · biosimilarStada Arzneimittel AG · EMEA/H/C/005548
- Hulio · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/004429
- HumiraAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/000481
- Hyrimoz · biosimilarSandoz GmbH · EMEA/H/C/004320
- Idacio · biosimilarFresenius Kabi Deutschland GmbH · EMEA/H/C/004475
- Imraldi · biosimilarSamsung Bioepis NL B.V. · EMEA/H/C/004279
- Libmyris · biosimilarStada Arzneimittel AG · EMEA/H/C/005947
- Yuflyma · biosimilarCelltrion Healthcare Hungary Kft. · EMEA/H/C/005188
Source: European Medicines Agency (EMA), product information
Turkey
- AmgevitaAMGEN İLAÇ TİC. LTD. ŞTİ. · 5 register entries
- HumiraABBVİE TIBBİ İLAÇLAR SAN. VE TİC. LTD. ŞTİ. · 5 register entries
- HyrımozSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- SimlandiABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 7 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Amgevita, Amsparity, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Libmyris, Yuflyma
- Liechtenstein
- Amsparity, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Libmyris, Yuflyma
- Norway
- Amgevita, Amsparity, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Libmyris, Yuflyma
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
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Sources
- European Medicines Agency. Humira – 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/humira-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AB.
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.