Prescribing information

 

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Key safety data for ILARIS in the treatment of FMF, HIDS/MKD, TRAPS and CAPS.

  • No opportunistic infections, cases of tuberculosis or deaths occurred1
  • The most frequently reported adverse events were infections (particularly respiratory infections), abdominal pain, headache, diarrhoea, arthralgia and injection site reactions.1 Physicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions which may predispose them to infections4

Adverse events and exposure-adjusted rates of adverse events in Epoch 2 (Weeks 0–16; double blind) and cumulative Epochs 2 and 3*1

  Epoch 2 Cumulative Epoch 2 and 3
  Combined Placebo ILARIS ILARIS
    crFMF MKD TRAPS crFMF MKD TRAPS
Exposure — patient-years 8.0 16.4 19.1 12.1 45.6 51.0 39.2
Adverse events — no. of events
(rate/100 patient-years)
             
  Including fever and disease flare 136 (1693.0) 134 (816.7) 251 (1313.6) 112 (925.7) 332 (728.2) 613 (1201.2) 265 (676.2)
  Excluding fever and disease flare 114 (1419.6) 126 (768.2) 243 (1272.2) 111 (917.3) 306 (671.0) 591 (1158.8) 261 (665.8)
  Infections only 19 (236.5) 28 (170.6) 72 (376.8) 26 (214.9) 79 (173.3) 160 (313.5) 58 (148.0)
Most common non-infectious adverse events – 
no. of events (rate/100 patient-years)
             
  Abdominal pain 9 (112.0) 6 (36.6) 6 (31.4) 4 (33.1) 12 (26.3) 15 (29.4) 10 (25.5)
  Headache 7 (87.1) 5 (30.5) 12 (62.8) 2 (16.5) 13 (28.5) 25 (49.0) 11 (28.1)
  Diarrhoea 4 (49.8) 7 (42.7) 10 (52.3) 2 (16.5) 9 (19.7) 20 (39.2) 8 (20.4)
  Arthralgia 2 (24.9) 2 (12.2) 9 (47.1) 1 (8.3) 7 (15.4) 20 (39.2) 9 (23.0)
  Injection-site reaction 1 (12.4) 13 (79.2) 8 (41.9) 8 (66.1) 20 (43.9) 17 (33.3) 11 (28.1)
Serious adverse events — no. of events
(rate/100 patient-years)
             
  Including disease flare 8 (99.6) 7 (42.7) 11 (57.6) 3 (24.8) 17 (37.3) 20 (39.2) 5 (12.8)
  Excluding disease flare 6 (74.7) 7 (42.7) 8 (41.9) 3 (24.8) 14 (30.7) 14 (27.4) 5 (12.8)
  Including infections only 2 (24.9) 1 (6.1) 4 (20.9) 0 3 (6.6) 7 (13.7) 0

Adapted from De Benedetti et al. 2018.1

  • In the β-Confident Registry, the largest documented CAPS cohort, ILARIS demonstrated a safety profile consistent with its clinical trial programme over 5 years2
  • In general, the incidence of adverse events in each dose group of ILARIS increased with age (<4 to <65 years)3
  • An increase in the dose of ILARIS from 2–<4 mg/kg to 4–<8 mg/kg was not associated with an increased incidence of adverse events in any age group3

5-year safety profile of ILARIS in the β-Confident Registry‡2

  No. of patients

(N=288)
Incidence rate per

100 patient-years
Overall adverse events   100.0
Infections and infestations   36.7
Vertigo 19 (6.6%) 3.7
Serious adverse events 62 (21.5%) 15.0
  Serious infections   4.1
Discontinuation of treatment 21 (7.3%)  
  Discontinuation due to adverse events 5 (1.7%)  
Deaths 1 (0.3%)§  

Adapted from Kuemmerle-Deschner et al. 2015.2

*An event that occurred in any patient after receiving at least one dose of ILARIS is listed under ILARIS.
The combined placebo group includes the patients in all three cohorts who were randomly assigned to placebo at baseline.
288 patients were enrolled with a mean±SD duration of 193±72 weeks.2
§
One death was reported due to metastatic rectal adenocarcinoma in a 76-year-old patient.2

Indications

ILARIS is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:

  • CAPS, including:
    • Muckle-Wells syndrome (MWS)
    • Neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous, articular syndrome (CINCA)
    • Severe forms of familial cold autoinflammatory syndrome (FCAS)/familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash
  • TRAPS
  • HIDS/MKD
  • FMF
    • ILARIS should be given in combination with colchicine, if appropriate.

CAPS, cryopyrin-associated periodic syndromes; crFMF, colchicine-resistant familial Mediterranean fever; FMF, familial Mediterranean fever; HIDS, hyperimmunoglobulin D syndrome; MKD, mevalonate kinase deficiency; SD, standard deviation; TRAPS, tumour necrosis factor receptor-associated periodic syndrome.

References

  1. De Benedetti F et al. N Engl J Med 2018;378(20):1908–1919.
  2. Kuemmerle-Deschner J et al. Pediatr Rheumatol 2015;13(Suppl 1):P3.
  3. Kuemmerle-Deschner JB et al. Abstract 1411 presented at 2018 ACR/ARHP Annual Meeting, 19–24 October 2018, Chicago, IL, USA.
  4. ILARIS® (canakinumab) Summary of Product Characteristics.
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UK | November 2021 | 160451
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]