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Indications and Clinical use:

^PrKINERET^® (anakinra) is indicated for:¹

Rheumatoid arthritis

• Reducing the signs and symptoms of active rheumatoid arthritis (RA) in patients 18 years of age or older
• Inhibiting the progression of structural damage by reducing erosions and cartilage degradation in patients with active RA despite treatment with stable doses of methotrexate (MTX)

KINERET can be used alone or in combination with other disease-modifying antirheumatic drugs (DMARDs), particularly MTX.

Cryopyrin-Associated Periodic Syndromes

• Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above

Geriatrics (>65 years of age): No differences in safety or efficacy were observed between geriatric and younger patients in the RA trials. No patients 
≥65 years of age were enrolled in the pivotal NOMID trial.

Pediatrics (<18 years of age): The efficacy of KINERET in children with RA (Juvenile Idiopathic Arthritis [JIA]) aged 0 to 18 years has not been 
established. KINERET is not recommended for children with NOMID who are <8 months of age.

Most serious warnings and precautions:

Serious infections: In patients with RA, an increased incidence of serious infections has been observed; discontinue KINERET if serious infection develops. In patients with NOMID, the risk of a disease flare when discontinuing KINERET treatment should be weighed against the potential risk of continued treatment. Treatment with KINERET should not be initiated in patients with active infections. The safety and efficacy of KINERET in immunosuppressed patients or in patients with chronic infections have not been evaluated.

Anaphylactic reactions: Allergic reactions, including anaphylactic reactions, angioedema, urticaria, rash and pruritus, have been reported; if these conditions are observed, discontinue KINERET and initiate appropriate therapy.

Other relevant warnings and precautions:

• In patients with NOMID who received high doses of KINERET over extended periods of time and presented with injection site amyloid deposits, isolated cases of systemic AIL1RAP (IL-1 receptor antagonist protein) amyloidosis have been reported during post-marketing use. To limit injection site amyloid deposits, rotate injection sites regularly. KINERET should not be injected into areas which are already swollen or red. In patients with confirmed injection site amyloid deposits, monitor closely for proteinuria
• Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported during post-marketing use in patients treated with KINERET, predominantly in pediatric patients. Patients with DRESS may require hospitalization, as this condition may be fatal. If signs and symptoms of DRESS are present and an alternative etiology cannot be established, KINERET must not be readministered and a different treatment considered
• Prior to initiating immunomodulatory therapies, including KINERET, test patients for latent tuberculosis infection; the safety of KINERET in individuals with latent tuberculosis is unknown
• Use of KINERET in combination with TNF-blocking agents is not recommended
• Live vaccines should not be given concurrently with KINERET
• Evaluate patients with renal impairment before initiating therapy; consider a dose schedule change for those with severe renal insufficiency or 
end-stage renal disease
• Known or suspected underlying airway inflammation in patients with asthma should be brought under control prior to initiating KINERET. Exercise caution in patients with underlying airway inflammation
• Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Exercise caution in nursing women
• Higher incidence of infections in the elderly population; exercise caution
• Assess neutrophil counts prior to initiating KINERET, and quarterly while receiving KINERET for a period up to 1 year; 
do not initiate if ANC <1 x 10⁹/L
  

For more information:
Please consult the Product Monograph at https://www.sobi.com/sites/sobi/files/2025-01/Kineret-Product-Monograph-en.pdf for important information relating to adverse reactions, drug interactions, and dosing information, which has not been discussed in this piece.
The Product Monograph is also available through our medical department at 1-866-773-5274.

AIRA = autoinflammatory rheumatoid arthritis; IL-1 = interleukin-1; NOMID = neonatal-onset multisystem inflammatory disease; RA = rheumatoid arthritis

Reference: 1. KINERET (anakinra) Product Monograph. SOBI. August 29, 2025.