Full Prescribing Information and Instructions for Use
For Patients and Caregivers
The Role of IL-1
About KINERET
Difficult-to-Treat RA
RA Efficacy
RA Safety
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NOMID
NOMID Efficacy
NOMID Safety
NOMID Case Study
DIRA Efficacy
DIRA Safety
Using KINERET
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KINERET [Prescribing Information]. Stockholm, Sweden: Swedish Orphan Biovitrum AB (publ).
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Indications and Important Safety Information
KINERET® (anakinra) is an interleukin-1 receptor antagonist indicated for:
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)
Close Indications and Important Safety Information
Cryopyrin-Associated Periodic Syndromes (CAPS)
Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)
Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
KINERET is contraindicated in patients 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 or DIRA patients, the risk of a disease 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. Patients with DIRA may have an increased risk of allergic reactions, particularly in the first several weeks after starting KINERET treatment
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
DIRA: The most common AEs are upper respiratory tract infections, rash, pyrexia, influenza-like illness, and gastroenteritis
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
KINERET is indicated for use in pediatric patients with NOMID and DIRA
Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly
KINERET is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function
Please see full Prescribing Information.
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