Anakinra 100mg/0.67ml solution for injection pre-filled syringes
Requires a prescription from a doctor or prescriber
Anakinra is a recombinant human interleukin-1 (IL-1) receptor antagonist (IL-1Ra) composed of 153 amino acid residues.
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Anakinra
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Anakinra
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1 branded products available
MHRA licensed products
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Kineret 100mg/0.67ml solution for injection pre-filled syringes
WHO defined daily dose (DDD)
100 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(4)
Anakinra for treating Still's disease (TA685)
Tocilizumab for the treatment of systemic juvenile idiopathic arthritis (TA238)
Rheumatoid arthritis in adults: management (NG100)
TNF-alpha inhibitors for treating active ankylosing spondylitis and non-radiographic axial spondyloarthritis (TA383)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 23 · Randomised trials: 15 · 2002–2026
Showing the 50 most relevant studies, sorted by most relevant.
Evdoxia Kyriazopoulou, Thomas Huet, Giulio Cavalli, et al.
The Lancet Rheumatology, 2021
Marty T. Mertens, Jasvinder A. Singh
The Journal of Rheumatology, 2009
- Arthritis, Rheumatoid
- Health Status
- Pain Measurement
Evdoxia Kyriazopoulou, Garyphallia Poulakou, Haralampos Milionis, et al.
Nature Medicine, 2021
- COVID-19 Drug Treatment
- COVID-19
- SARS-CoV-2
Pierre‐Louis Tharaux, Gilles Pialoux, Arthur Pavot, et al.
The Lancet Respiratory Medicine, 2021
- COVID-19 Drug Treatment
- Critical Care Outcomes
- SARS-CoV-2
Fasihul Khan, Iain Stewart, Laura Fabbri, et al.
Thorax, 2021
- COVID-19 Drug Treatment
- COVID-19
- SARS-CoV-2
Ilan Ben‐Zvi, Olga Kukuy, Eitan Giat, et al.
Arthritis & Rheumatology, 2016
- Colchicine
- Drug Resistance
- Familial Mediterranean Fever
Stanley Cohen, Eric R. Hurd, John J. Cush, et al.
Arthritis & Rheumatism, 2002
- Antibodies
- Arthritis, Rheumatoid
- Blood Sedimentation
Pierre Quartier, Florence Allantaz, Rolando Cimaz, et al.
Annals of the Rheumatic Diseases, 2010
- Antibodies, Bacterial
- Arthritis, Juvenile
- Blood Sedimentation
Stanley Cohen, L W Moreland, J J Cush, et al.
Annals of the Rheumatic Diseases, 2004
- Arthritis, Rheumatoid
- Immunosuppressive Agents
- Methotrexate
George Nuki, Barry Bresnihan, Moraye B. Bear, et al.
Arthritis & Rheumatism, 2002
- Arthritis, Rheumatoid
- Long-Term Care
- Recombinant Proteins
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
4 to 6 hours
Mechanism
Interleukin-1 (IL-1) plays an important role in inflammation and immunological responses.
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
95%
Half-life
4 to 6 hours
Protein binding
Volume of distribution
18.5 L
[L41628]
Metabolism
Elimination
[L35415]
Clearance
50-80 mL/min
[L41628]…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Anakinra is produced using the E. Coli bacterial expression system. On November 14, 2001, it was approved by the FDA for the treatment of rheumatoid arthritis. It was later approved for the treatment of NOMID and DIRA on December 21, 2012, and December 18, 2020, respectively. A few studies have evaluated the use of anakinra for the treatment of coronavirus disease 2019 (COVID-19).[A247265] On November 8, 2022, the FDA issued an emergency use authorization (EUA) of anakinra for the treatment of COVID-19 in hospitalized patients who are at risk of progressing to severe respiratory failure.[L43932]
[L35415]
Anakinra is also indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) and the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
[L35415]
Anakinra is also used off-label for the treatment of several inflammatory diseases.
[A247000]
The FDA has issued an emergency use authorization (EUA) for the emergency use of anakinra for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Since anakinra is approved for this condition under EUA, the drug should only be used when there are no alternative treatment available.
[L43927]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1041 interactions
[L35415]
Sepsis trials were performed using mean calculated doses up to 35 times the ones given to patients with RA over 72 hours. Anakinra did not produce any serious toxicities at this dose range.
[L35415]
In preclinical studies done in rats, where up to 100 mg/kg/day were administered either intravenously or subcutaneously over 14 days, and given at doses of 2, 20 or 200 mg/kg/day subcutaneously for 6 months, anakinra was well tolerated. Toxicity ranged from mild to moderate, and dose-related inflammation, hemorrhage and fibrosis at the injection site were detected in both rats and monkeys.
[L41634]
The no observable adverse effect level (NOAEL) in rats receiving a daily subcutaneous dose of anakinra for 6 months was 2 mg/kg/day.
In rats receiving a daily intravenous injection of anakinra for 14 or 28 days, the NOAEL was 30 mg/kg/day. The NOAEL in Rhesus monkeys was 150 mg/kg/day when anakinra was administered via intravenous infusion for 7 days, 10-30 mg/kg/day when administered via intravenous bolus injection for 14 days and 5 mg/kg/day when administered subcutaneously for 14 days.
[L41634]
Anakinra had no effects on fertility and reproductive capacity in both male and female rats given the maximum recommended human dose.
[L35415]
Anakinra can also be used in the treatment of neonatal-onset multisystem inflammatory disease (NOMID) and deficiency of interleukin-1 receptor antagonist (DIRA).[L35415] Patients with NOMID have spontaneous mutations in CIAS1/NLRP3, a gene that encodes cryopyrin, an inflammasome component. When activated, the inflammasome enhances and promotes the production of IL-1β, an isoform of IL-1.[A246898][L35415] DIRA is an autoinflammatory disease caused by mutations in the IL1RN gene. These mutations reduce the amount of IL-1Ra that is secreted, leading to the unopposed action of IL-1.[L35415] Anakinra controls NOMID and DIRA symptoms by inhibiting IL-1 activity.[L35415]
Anakinra has been associated with a higher probability of developing a severe infection, and the use of TNF blocking agents can increase this incidence.[L35415] Hypersensitivity reactions have been reported in patients using anakinra. The prevalence of allergic reactions may be higher in patients with deficiency of interleukin-1 receptor antagonist (DIRA), since they lack the naturally occurring IL-1Ra.[L35415] Anakinra can also decrease neutrophil counts in patients. Therefore, neutrophil counts should be assessed before initiating anakinra.[L35415]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L35415]
In a phase 1, single-center, randomized, sequential single-dose escalation PK study done in patients with stable RA, AUC increased in a relatively dose-proportional manner.
While the tmax and Cmax fluctuated across the different doses provided to these patients (range from 0.5 to 6 mg/kg), clearance appeared to be consistent.
[L41628]
In patients with neonatal-onset multisystem inflammatory disease (NOMID) treated with a subcutaneous dose of 3 mg/kg of anakinra for an average of 3.5 years (n=16), Cmax was 3628 ng/mL and C24h was 203 ng/mL.
[L35415]
[L35415]
[L41628]
[L35415]
[L41628]
Clearance is variable and increases with increasing creatinine clearance and body weight. However, gender and age were not significant factors.
[L35415]
In patients with mild (creatinine clearance 50-80 mL/min) and moderate (creatinine clearance 30-49 mL/min) renal impairment, the mean plasma clearance of anakinra was 16% and 50% lower, respectively. In patients with severe renal insufficiency and end-stage renal disease (creatinine clearance < 30 mL/min), the mean plasma clearance of anakinra was 70% and 75% lower, respectively.
[L35415]
Proteins and enzymes this drug interacts with in the body
PMID:2950091 PMID:37315560
After binding to interleukin-1 associates with the coreceptor IL1RAP to form the high affinity interleukin-1 receptor complex which mediates interleukin-1-dependent activation of NF-kappa-B, MAPK and other pathways. Signaling involves the recruitment of adapter molecules such as TOLLIP, MYD88, and IRAK1 or IRAK2 via the respective TIR domains of the receptor/coreceptor subunits. Binds ligands with comparable affinity and binding of antagonist IL1RN prevents association with IL1RAP to form a signaling complex.
Involved in IL1B-mediated costimulation of IFNG production from T-helper 1 (Th1) cells PMID:10653850
ATC L04AC03
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Anakinra
Additional database identifiers
Drugs Product Database (DPD)
12604
HUGO Gene Nomenclature Committee (HGNC)
HGNC:5993
GenAtlas
IL1R1
GeneCards
IL1R1
GenBank Gene Database
X16896
GenBank Protein Database
33801
Guide to Pharmacology
1734
UniProt Accession
IL1R1_HUMAN
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q415411), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.