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ARCALYST (rilonacept) for injection

A PROVEN TREATMENT WITH ESTABLISHED SAFETY

Proven Safety Profile1

Treatment-emergent adverse events (TEAEs) occurring in the RI and the RW periods of the RHAPSODY study in ≥5% of patients

  • Injection-site reactions include events occurring at the injection site, other events anatomically distant from the injection site may have been assessed as injection-site reactions.
  • Pooled terms, patients counted only once within a preferred term or system organ class.
    • TEAE
    ARCALYST or Placebo, n (%) (N=86)

    Patients with any TEAE

    74 (86.0)

     Injection-site reactions*†

    29 (33.7)

    Upper respiratory infections†

    19 (22.1)

    Arthralgia

    10 (11.6)

    Myalgia

    10 (11.6)

    Headache

    7 (8.1)

    Musculoskeletal chest pain

    7 (8.1)

    Back pain

    6 (7.0)

    Cough

    6 (7.0) 

    Diarrhea

    5 (5.8) 

    Fatigue

    5 (5.8) 

    During the RI/RW periods (n=86):

    • No adverse events (AEs) led to death 
    • Four AEs led to treatment discontinuation
    • Five serious AEs (SAEs) occurred: 1 during the RI period (stroke due to carotid artery dissection), 1 in the ARCALYST treatment arm (squamous cell carcinoma), 1 in the placebo arm (cardiac flutter), and 2 in the placebo arm following ARCALYST bailout (pyrexia and ileus) 

    During the LTE period (n=74):

    • 62 (83.8%) of patients experienced TEAEs
    • Six patients experienced SAEs: (1. pneumothorax; 2. acute endocarditis, aortic valve disease, acute myocardial infarction, pericarditis; 3. transient ischemic attack, coronavirus infection; 4. worsening of aortic insufficiency; 5. pneumonia, pneumonia viral [COVID‐19]; and 6. left ventricular failure, hip fracture, bile duct stone, cardiac device malfunction)
    • Three AEs led to treatment discontinuation and no AEs led to death
    • TEAEs of interest: upper respiratory infections and injection-site reactions were reported at 16.2% and 6.8%, respectively

    Reference: 1. Data on file. Kiniksa Pharmaceuticals.

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    Indication

    ARCALYST® (rilonacept) is an interleukin-1 blocker indicated for:

    • Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older.
    • Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older. 
    • Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more.

    Important Safety Information

    Warnings and Precautions

    • Interleukin-1 (IL-1) blockade may interfere with the immune response to infections. Treatment with another medication that works through inhibition of IL-1 or inhibition of tumor necrosis factor (TNF) is not recommended as this may increase the risk of serious infection. Serious, life-threatening infections have been reported in patients taking ARCALYST. Do not initiate treatment with ARCALYST in patients with an active or chronic infection.
    • Discontinue ARCALYST if a patient develops a serious infection.
    • It is possible that taking drugs such as ARCALYST that block IL-1 may increase the risk of tuberculosis (TB) or other atypical or opportunistic infections.
    • Although the impact of ARCALYST on infections and the development of malignancies is not known, treatment with immunosuppressants, including ARCALYST, may result in an increase in the risk of malignancies.
    • Hypersensitivity reactions associated with ARCALYST occurred in clinical trials. Discontinue ARCALYST and initiate appropriate therapy if a hypersensitivity reaction occurs. 
    • Increases in non-fasting lipid profile parameters occurred in patients treated with ARCALYST in clinical trials. Patients should be monitored for changes in their lipid profiles.
    • Since no data are available, avoid administration of live vaccines while patients are receiving ARCALYST. ARCALYST may interfere with the normal immune response to new antigens, so vaccines may not be effective in patients receiving ARCALYST. It is recommended that, prior to initiation of therapy with ARCALYST, patients receive all recommended vaccinations, as appropriate.

    Adverse Reactions

    • In patients with CAPS or RP, the most common adverse reactions (≥10%) include injection-site reactions and upper respiratory tract infections.
    • In patients with DIRA, the most common adverse reactions (>10%) include upper respiratory tract infections, rash, otitis media, pharyngitis, and rhinorrhea.

    Drug Interactions

    • In patients being treated with CYP450 substrates with narrow therapeutic indices, therapeutic monitoring of the effect or drug concentration should /pi.pdfbe performed, and the individual dose of the medicinal product may need to be adjusted.

    For more information about ARCALYST, see full Prescribing Information.