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Accession Number
DB00026  (BTD00060, BIOD00060)
Biologic Classification
Protein Based Therapies
Interleukin-based products

Anakinra is a recombinant, nonglycosylated human interleukin-1 receptor antagonist (IL-1Ra). The difference between anakinra and the native human IL-1Ra is that anakinra has an extra methionine residue at the amino terminus. It is manufactured by using the E. coli expression system. Anakinra is composed of 153 amino acid residues. FDA approved on November 14, 2001.

Protein structure
Protein chemical formula
Protein average weight
17257.6 Da
>DB00026 sequence
Download FASTA Format
  • Anakinra
  • IL-1RA
  • Interleukin-1 receptor antagonist anakinra
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
KineretInjection, solution100 mg/0.67mLSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2009-12-15Not applicableUs
KineretInjection, solution100 mg/0.67mlSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2002-03-08Not applicableEu
KineretInjection, solution100 mgSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2002-03-08Not applicableEu
KineretInjection, solution100 mg/0.67mlSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2002-03-08Not applicableEu
KineretSolution150 mgSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2002-05-29Not applicableCanada
KineretInjection, solution100 mgSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2002-03-08Not applicableEu
KineretInjection, solution100 mgSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2002-03-08Not applicableEu
KineretInjection, solution100 mg/0.67mlSubcutaneousSWEDISH ORPHAN BIOVITRUM AB (PUBL)2002-03-08Not applicableEu
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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CAS number



For the treatment of adult rheumatoid arthritis and treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

Associated Conditions

Used to treat rheumatoid arthritis, Anakinra blocks the biologic activity of IL-1 by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses. Patients with rheumatoid arthritis have elevated levels of IL-1. The levels of the naturally occurring IL-1Ra in synovium and synovial fluid from rheumatoid arthritis (RA) patients are not sufficient to compete with the elevated amount of locally produced IL-1. Increasing the levels of IL-1Ra by artificial means reduces the negative effects (cartilage degradation, bone resorption) of IL-1.

Mechanism of action

Anakinra binds competitively to the Interleukin-1 type I receptor (IL-1RI), thereby inhibiting the action of elevated levels IL-1 which normally can lead to cartilage degradation and bone resorption.

AInterleukin-1 receptor type 1
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

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When a 70 mg subcutaneous bolus injection is given to healthy subjects, the absolute bioavailability is 95%. Accumulation does not occur following daily subcutaneous doses. Tmax, SubQ, 1-2 mg/kg, healthy subjects = 3-7 hours; Cmax, SubQ, 3 mg/kg once daily, NOMID patients = 3628 ng/mL.

Volume of distribution
Not Available
Protein binding
Not Available
Not Available
Route of elimination
Not Available
Half life

Healthy subjects = 4 - 6 hours; NOMID patients = 5.7 hours (range of 3.1 - 28.2 hours).


Clearance is variable and increases with increasing creatinine clearance and body weight. However, gender and age were not significant factors.


Most common adverse reactions (incidence ≥ 5%) are injection site reaction, worsening of rheumatoid arthritis, upper respiratory tract infection, headache, nausea, diarrhea, sinusitis, arthralgia, flu like-symptoms, and abdominal pain when anakinra is used in RA patients. In NOMID patients, the most common AEs during the first 6 months of treatment (incidence >10%) are injection site reaction, headache, vomiting, arthralgia, pyrexia, and nasopharyngitis.

Affected organisms
  • Humans and other mammals
Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
(R)-warfarinThe metabolism of (R)-warfarin can be increased when combined with Anakinra.
(S)-WarfarinThe metabolism of (S)-Warfarin can be increased when combined with Anakinra.
2-MethoxyethanolThe risk or severity of adverse effects can be increased when Anakinra is combined with 2-Methoxyethanol.
4-hydroxycoumarinThe metabolism of 4-hydroxycoumarin can be increased when combined with Anakinra.
4-MethoxyamphetamineThe metabolism of 4-Methoxyamphetamine can be increased when combined with Anakinra.
6-O-benzylguanineThe metabolism of 6-O-benzylguanine can be increased when combined with Anakinra.
8-azaguanineThe metabolism of 8-azaguanine can be increased when combined with Anakinra.
8-chlorotheophyllineThe metabolism of 8-chlorotheophylline can be increased when combined with Anakinra.
9-(N-methyl-L-isoleucine)-cyclosporin AThe risk or severity of adverse effects can be increased when Anakinra is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
9-DeazaguanineThe metabolism of 9-Deazaguanine can be increased when combined with Anakinra.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

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  • Action

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Food Interactions
Not Available


General References
  1. Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [PubMed:11752352]
  2. Lequerre T, Quartier P, Rosellini D, Alaoui F, De Bandt M, Mejjad O, Kone-Paut I, Michel M, Dernis E, Khellaf M, Limal N, Job-Deslandre C, Fautrel B, Le Loet X, Sibilia J: Interleukin-1 receptor antagonist (anakinra) treatment in patients with systemic-onset juvenile idiopathic arthritis or adult onset Still disease: preliminary experience in France. Ann Rheum Dis. 2008 Mar;67(3):302-8. Epub 2007 Oct 18. [PubMed:17947302]
External Links
PubChem Substance
Therapeutic Targets Database
ATC Codes
L04AC03 — Anakinra
AHFS Codes
  • 92:36.00 — Disease-modifying Antirheumatic Agents
FDA label
Download (62.3 KB)

Clinical Trials

Clinical Trials
0Active Not RecruitingTreatmentAdenocarcinoma of the Pancreas1
0Not Yet RecruitingTreatmentAnterior Cruciate Ligament Injuries1
1Active Not RecruitingTreatmentAdvanced Cancers / Advanced Malignant Neoplasm / Metastatic Malignant Neoplasm / Recurrent Malignant Neoplasm / Refractory Malignant Neoplasm1
1Active Not RecruitingTreatmentMalignant Neoplasm of Pancreas1
1CompletedNot AvailablePostprandial Fatigue1
1CompletedBasic ScienceHealthy Control Subjects1
1CompletedTreatmentFamilial Cold Autoinflammatory Syndrome (FCAS)1
1CompletedTreatmentHealthy Volunteers1
1CompletedTreatmentPulmonary Arterial Hypertension (PAH)1
1CompletedTreatmentUnspecified Adult Solid Tumor, Protocol Specific1
1RecruitingTreatmentKnee Osteoarthritis (Knee OA)1
1RecruitingTreatmentMacrophage Activation Syndrome1
1TerminatedOtherHuman Immunodeficiency Virus (HIV) Infections / Neurologic Disorders1
1TerminatedTreatmentAllergic Disease / Anakinra / Atopic Dermatitis (AD) / Dermatitis, Eczematous / Kineret1
1, 2Active Not RecruitingTreatmentIndolent Plasma Cell Myeloma / Plasma Cell Myeloma / Smoldering Plasma Cell Myeloma1
1, 2CompletedOtherHeart Failure1
1, 2CompletedTreatmentAutoimmune Inner Ear Disease / Sensorineural Hearing Loss1
1, 2CompletedTreatmentAutoimmune/Connective Tissue Diseases / Immune System Diseases1
1, 2CompletedTreatmentCorneal Neovascularization1
1, 2CompletedTreatmentHeart Failure1
1, 2CompletedTreatmentKnee Injuries1
1, 2CompletedTreatmentPosterior Blepharitis1
1, 2CompletedTreatmentType 1 Insulin-Dependent Diabetes Mellitus2
1, 2Enrolling by InvitationTreatmentAsthma Bronchial2
1, 2RecruitingTreatmentMucocutaneous Lymph Node Syndrome1
1, 2RecruitingTreatmentType 1 Insulin-Dependent Diabetes Mellitus1
1, 2TerminatedTreatmentArthropathy, Neurogenic / Nervous System Malformations / Optic discs blurred / Urticarias1
1, 2TerminatedTreatmentHearing Loss, Sudden1
1, 2TerminatedTreatmentPulmonary Hypertension (PH)1
2Active Not RecruitingTreatmentAcute Gouty Arthritis1
2CompletedTreatmentAcute Myocardial Infarction (AMI) / Heart Failure1
2CompletedTreatmentAdult-Onset Still's Disease1
2CompletedTreatmentHeart Failure With Normal Ejection Fraction1
2CompletedTreatmentHidradenitis Suppurativa (HS)2
2CompletedTreatmentJuvenile Chronic Arthritis1
2CompletedTreatmentMetastatic Colorectal Cancers1
2CompletedTreatmentMultiple Myeloma and Plasma Cell Neoplasm1
2CompletedTreatmentOsteoarthritis (OA)1
2CompletedTreatmentPrimary Sjogren / Tiredness1
2CompletedTreatmentRheumatoid Arthritis1
2CompletedTreatmentType 2 Diabetes Mellitus1
2Not Yet RecruitingTreatmentAnterior Cruciate Ligament Tear1
2Not Yet RecruitingTreatmentAutoimmune Diseases / Inflammatory Diseases1
2Not Yet RecruitingTreatmentIntracerebral Hemorrhage1
2Not Yet RecruitingTreatmentTraumatic Brain Injury (TBI)1
2RecruitingSupportive CareMultiple Myeloma (MM)1
2RecruitingTreatmentAcrodermatitis Continua of Hallopeau / Palmoplantar Pustulosis / Pustular Dermatosis / Pustular Psoriasis / Sneddon-Wilkinson1
2RecruitingTreatmentBiotherapy / Uveitis1
2RecruitingTreatmentChildren / Mucocutaneous Lymph Node Syndrome1
2RecruitingTreatmentEnd-Stage Renal Disease (ESRD)1
2RecruitingTreatmentHeart Failure, Systolic / Inflammatory Reaction1
2RecruitingTreatmentMacrophage Activation Syndrome / Sepsis1
2RecruitingTreatmentPolycystic Ovaries Syndrome1
2RecruitingTreatmentAcute Pericarditis1
2TerminatedTreatmentRefractory Hemochromatosis Rheumatism1
2TerminatedTreatmentRheumatoid Arthritis1
2Unknown StatusTreatmentAmyotrophic Lateral Sclerosis (ALS)1
2Unknown StatusTreatmentDiabetes Mellitus (DM)1
2Unknown StatusTreatmentInsulin Resistance / Type 2 Diabetes Mellitus1
2WithdrawnTreatmentChronic Kidney Disease (CKD) / Heart Failure, Systolic / Renal Disease, End Stage1
2WithdrawnTreatmentType I Diabetes1
2, 3CompletedTreatmentAcute Alcoholic Hepatitis1
2, 3CompletedTreatmentAcute Myocardial Infarction (AMI)1
2, 3CompletedTreatmentDermatomyositis / Inclusion Body Myositis (IBM) / Polymyositis1
2, 3CompletedTreatmentHeart Failure2
2, 3CompletedTreatmentMyalgic Encephalomyelitis (ME)1
2, 3CompletedTreatmentSystemic-Onset Juvenile Idiopathic Arthritis1
2, 3CompletedTreatmentType 1 Insulin-Dependent Diabetes Mellitus1
2, 3RecruitingTreatmentAcute Gouty Arthritis / Chronic Kidney Disease (CKD)1
2, 3RecruitingTreatmentMyocarditis Acute1
3CompletedNot AvailableHypersecretion; Cortisol / Metabolic Syndromes1
3CompletedTreatmentBMI >30 kg/m2 / Hypogonadism / Metabolic Syndromes1
3CompletedTreatmentFamilial Mediterranean Fever (FMF )1
3CompletedTreatmentRheumatoid Arthritis1
3CompletedTreatmentST Segment Elevation Acute Myocardial Infarction1
3Not Yet RecruitingTreatmentGiant Cells Arteritis1
3RecruitingTreatmentStill's Disease, Adult-Onset / Still's Disease, Juvenile-Onset1
3RecruitingTreatmentSubarachnoid Hemorrhage1
4Active Not RecruitingTreatmentKnee Injuries1
4CompletedTreatmentIdiopathic Recurrent Pericarditis1
4CompletedTreatmentRheumatoid Arthritis2
4TerminatedTreatmentRheumatoid Arthritis / Type 2 Diabetes Mellitus1
Not AvailableActive Not RecruitingNot AvailableCryopyrin-associated Periodic Syndromes (CAPS)1
Not AvailableCompletedNot AvailablePsoriatic Arthritis / Rheumatoid Arthritis / Spondyloarthritis1
Not AvailableCompletedNot AvailableRheumatoid Arthritis2
Not AvailableCompletedBasic ScienceType 2 Diabetes Mellitus1
Not AvailableCompletedDiagnosticLate Dumping Syndrome / Post-gastrointestinal bypass surgery / Postprandial Hypoglycemia1
Not AvailableCompletedOtherAdiposity1
Not AvailableCompletedTreatmentCoronary Artery Disease / Inflammatory Reaction / Rheumatoid Arthritis1
Not AvailableCompletedTreatmentEnd Stage Renal Disease (ESRD)1
Not AvailableCompletedTreatmentHeart Failure1
Not AvailableEnrolling by InvitationNot AvailableStill Disease, Juvenile Onset1
Not AvailableUnknown StatusNot AvailableGlucose tolerance impaired / Impaired Insulin Secretion / Type 2 Diabetes Mellitus1
Not AvailableUnknown StatusTreatmentInflammatory Reaction / Pain NOS1
Not AvailableWithdrawnBasic ScienceType 2 Diabetes Mellitus1


Not Available
  • Amgen Inc.
  • BioVitrum AB
Dosage forms
Injection, solutionSubcutaneous100 mg/0.67ml
Injection, solutionSubcutaneous100 mg
SolutionSubcutaneous150 mg
Unit descriptionCostUnit
Kineret 1 Box = 7 Syringes, 4.69ml Box449.9USD box
Kineret 100 mg/0.67 ml syr61.8USD syringe
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patent NumberPediatric ExtensionApprovedExpires (estimated)
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

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Experimental Properties
hydrophobicity-0.412Not Available
isoelectric point5.46Not Available


Not Available
Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available


Pharmacological action
General Function
Transmembrane signaling receptor activity
Specific Function
Receptor for IL1A, IL1B and IL1RN. After binding to interleukin-1 associates with the corecptor IL1RAP to form the high affinity interleukin-1 receptor complex which mediates interleukin-1-dependen...
Gene Name
Uniprot ID
Uniprot Name
Interleukin-1 receptor type 1
Molecular Weight
65401.91 Da
  1. Tang YH, Zhang SP, Liang Y, Deng CQ: [Effects of Panax notoginseng saponins on mRNA expressions of interleukin-1 beta, its correlative factors and cysteinyl-aspartate specific protease after cerebral ischemia-reperfusion in rats]. Zhong Xi Yi Jie He Xue Bao. 2007 May;5(3):328-32. [PubMed:17498496]
  2. Dayer JM: The pivotal role of interleukin-1 in the clinical manifestations of rheumatoid arthritis. Rheumatology (Oxford). 2003 May;42 Suppl 2:ii3-10. [PubMed:12817089]
  3. Vamvakopoulos J, Green C, Metcalfe S: Genetic control of IL-1beta bioactivity through differential regulation of the IL-1 receptor antagonist. Eur J Immunol. 2002 Oct;32(10):2988-96. [PubMed:12355453]
  4. Do H, Vasilescu A, Carpentier W, Meyer L, Diop G, Hirtzig T, Coulonges C, Labib T, Spadoni JL, Therwath A, Lathrop M, Matsuda F, Zagury JF: Exhaustive genotyping of the interleukin-1 family genes and associations with AIDS progression in a French cohort. J Infect Dis. 2006 Dec 1;194(11):1492-504. Epub 2006 Oct 26. [PubMed:17083033]
  5. Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [PubMed:11752352]
  6. So A, De Smedt T, Revaz S, Tschopp J: A pilot study of IL-1 inhibition by anakinra in acute gout. Arthritis Res Ther. 2007;9(2):R28. [PubMed:17352828]
  7. Vannier E, Kaser A, Atkins MB, Fantuzzi G, Dinarello CA, Mier JW, Tilg H: Elevated circulating levels of soluble interleukin-1 receptor type II during interleukin-2 immunotherapy. Eur Cytokine Netw. 1999 Mar;10(1):37-42. [PubMed:10210771]

Drug created on June 13, 2005 07:24 / Updated on June 16, 2019 06:40