Full Prescribing Information and Instructions for Use
For Patients and Caregivers
Kineret and IL-1 Patient Insights Kineret RA Data Kineret NOMID Data KINERET® On TRACK Practice Support

Kineret is used to treat some patients with RA and patients with the rare disease NOMID1

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Kineret is a recombinant IL-1 receptor antagonist (IL-1Ra), which blocks IL-1—a key mediator of inflammation that could be a factor in the destructive nature of RA1

  • Kineret, a recombinant IL-1 receptor antagonist (IL-1Ra), blocks the biologic activity of both IL-1α and IL-1β by inhibiting IL-1 binding to the IL-1 type 1 receptor (IL-1R1), which is expressed in a wide variety of tissues and organs1
  • Secretion of IL-1β has an important role in systemic inflammation and in the signs and symptoms of RA and NOMID1,2,3
  • Kineret supplements naturally occurring endogenous IL-1Ra, working in a similar way to block the IL-1 receptor without removing endogenous IL-1 from the circulation2

Watch the Kineret Mechanism of Action video

Interleukin-1 (IL-1) is a mediator of the inflammatory and destructive nature of RA2

  • Extensive evidence from both in vivo and in vitro experiments indicate that IL-1, a prototypic proinflammatory cytokine, is involved with the mechanisms that lead to progressive joint destruction in RA4
  • RA symptoms that are unresponsive to multiple biologic therapies may be a sign of IL-1—mediated inflammation
  • Inflammatory symptoms of RA that are driven by IL-1 may include joint pain, rash, and fever5-9

IL-1 drives pathogenesis of NOMID

  • NOMID is often associated with mutations in the CIAS1/NLRP3 gene, which encodes the protein cryopyrin (NLRP3), an important component of the NLRP3 inflammasome10,11
    • Although approximately 40% of patients test negative for CIAS1/NLRP3 mutations using conventional genetic analyses, advanced testing techniques have identified somatic NLRP3 mosaicism in ~70% of these patients11
  • A mutation in cryopyrin leads to an increased rate of inflammasome assembly without the necessary inflammatory stimuli10,12
  • Increased inflammasome activity results in excessive production of the pro-inflammatory cytokine IL-1β6,12,13

IL-1=interleukin-1; IL-1R1=IL-1 receptor type 1; NLRP3=nucleotide oligomerization domain-like receptors with pyrin domain-containing proteins

Review Kineret efficacy data in NOMID


Kineret® is an interleukin-1 receptor antagonist indicated for:

Rheumatoid Arthritis (RA)

  • Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease-modifying antirheumatic drugs (DMARDs)

Cryopyrin-Associated Periodic Syndromes (CAPS)

  • Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)


  • Kineret is contraindicated in patient with known hypersensitivity to E. coli-derived proteins, Kineret, or to any components of the product
  • In RA, discontinue use if serious infection develops. In Kineret-treated NOMID patients, the risk of a NOMID flare when discontinuing Kineret treatment should be weighed against the potential risk of continued treatment. Do not initiate Kineret in patients with active infections
  • Use in combination with Tumor Necrosis Factor (TNF) blocking agents is not recommended
  • Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported
  • The impact of treatment with Kineret on active and/or chronic infections and the development of malignancies is not known
  • Live vaccines should not be given concurrently with Kineret
  • Neutrophil counts should be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly for 3 months, and thereafter quarterly for a period up to 1 year
  • RA: 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
  • NOMID: The most common AEs during the first 6 months of treatment (incidence > 10%) are injection site reaction, headache, vomiting, arthralgia, pyrexia, and nasopharyngitis
  • A higher rate of serious infections has been observed in RA patients treated with concurrent Kineret and etanercept therapy than in patients treated with etanercept alone. Use of Kineret in combination with TNF blocking agents is not recommended
  • Because there is a higher rate of infections in the elderly population in general, caution should be used in treating the elderly
  • Kineret is substantially excreted by the kidney, and the risk of toxic reactions to Kineret may be greater in patients with impaired renal function

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