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

Could Kineret be right for your patient with RA?

  • Kineret is a daily injection treatment that blocks both IL-1α and IL-1β, and is indicated in patients with moderately to severely active RA, 18 years of age or older who have failed 1 or more DMARDs1
  • Kineret has been shown to reduce the signs and symptoms of RA and slow the progression of structural damage1
  • Kineret has a short half-life (4-6 hours)1

Consider Kineret

When suspecting IL-1 as a key mediator of inflammation in patients with recurring symptoms1

  • IL-1 driven inflammatory symptoms
    • In some patients, RA may have a significant autoinflammatory component2
  • Treatment-resistant disease
    • RA symptoms that are non-responsive to multiple biologic therapies may be a sign of inflammation mediated by IL-1

When complicating conditions and concurrent medications are a treatment consideration

  • Safety established in high-risk RA patients1,3
    • High-risk RA patients include those with complicating conditions, such as asthma, diabetes, chronic obstructive pulmonary disease, coronary artery disease, congestive heart failure, and pneumonia
    • In a large clinical trial, the well-established safety profile of Kineret was demonstrated in patients with RA with complicating conditions, many of whom were receiving concurrent RA medications (excluding anti-TNFs)3

IL-1 driven inflammatory symptoms of RA may include4-8:

Joint pain
and swelling

Fever

Rash

In clinical trials, Kineret significantly reduced signs, symptoms, and joint damage associated with RA1

6% of patients with RA achieved ACR70 with Kineret at 6 months

  • Most clinical responses occurred within 12 weeks of enrollment, but some patients continued to experience improvement between month 3 and month 61
  • Patients treated with Kineret had significant reductions in Total Modified Sharp Score (TSS) and joint space narrowing (JSN) score vs. placebo at 12 months1
    • Change in TSS was 1.7 points in patients treated with Kineret + methotrexate, vs 2.6 in patients treated with placebo + methotrexate (P< 0.001, 95% CI=0.9 [0.3, 1.6])
    • Change in JSN score was 0.7 points in patients treated with Kineret + methotrexate, vs 1.1 in patients treated with placebo + methotrexate (P< 0.001, 95% CI=0.4 [0.1, 0.7])

Study design: In a randomized, double-blind, placebo-controlled trial of 899 patients with active RA who have been on a stable dose of methotrexate (10 to 25 mg/week) for at least 8 weeks. Patients were randomized to Kineret (n=250) or placebo (n=251) in addition to their stable doses of methotrexate. The first 501 patients were evaluated for signs and symptoms of active RA. The total 899 patients were evaluated for progression of structural damage.1

ACR Response at 6 months1

Kineret has a well-documented safety profile in RA with >15 years of clinical and patient experience1

The most common adverse event associated with Kineret was injection-site reaction (ISR)1

  • The majority of ISRs were mild (72.6% mild, 24.1% moderate, and 3.2% severe)
  • ISRs were typically reported within the first 4 weeks of therapy and lasted for 14 to 28 days
  • The safety profile of Kineret was demonstrated in a high-risk RA patient population3
    • Broad range of disease activity
    • Variety of complicating conditions (asthma, diabetes, chronic obstructive pulmonary disease, coronary artery disease, congestive heart failure, pneumonia)
    • Variety of concurrent medications including stable doses of DMARDs, corticosteroids, and/or NSAIDs and excluding anti-TNF agents

Percent of patients with RA reporting adverse events1

KINERET® On TRACK and KINERET On TRACK Guidance can help you educate and support your patients as they learn to inject Kineret and manage ISRs

Learn more here

INDICATION

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)

IMPORTANT SAFETY INFORMATION

  • 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

Please see full Prescribing Information.