1. Medicines
  2. Rare diseases
  3. ILARIS® (canakinumab)
  4. Safety profile and dosing

Prescribing information

 

Safety profile and dosing

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

Safety profile of ILARIS in FMF, HIDS/MKD and TRAPS1

  • No opportunistic infections, cases of tuberculosis or deaths occurred.1
  • The most frequently reported adverse events were infections (particularly respiratory infections), abdominal pain, headache, diarrhoea, arthralgia and injection site reactions.1

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

  Combined Placebo† ILARIS
    crFMF MKD TRAPS
Exposure — patient-years 8.0 16.4 19.1 12.1
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)
  Excluding fever and disease flare 114 (1419.6) 126 (768.2) 243 (1272.2) 111 (917.3)
  Infections only 19 (236.5) 28 (170.6) 72 (376.8) 26 (214.9)
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)
  Headache 7 (87.1) 5 (30.5) 12 (62.8) 2 (16.5)
  Diarrhoea 4 (49.8) 7 (42.7) 10 (52.3) 2 (16.5)
  Arthralgia 2 (24.9) 2 (12.2) 9 (47.1) 1 (8.3)
  Injection-site reaction 1 (12.4) 13 (79.2) 8 (41.9) 8 (66.1)
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)
  Excluding disease flare 6 (74.7) 7 (42.7) 8 (41.9) 3 (24.8)
  Including infections only 2 (24.9) 1 (6.1) 4 (20.9) 0

Adapted from De Benedetti et al. 2018.1

ILARIS has a convenient 4-weekly dosing schedule2

Text reading 'once every 4 weeks'

In FMF, HIDS/MKD and TRAPS, ILARIS is administered as a subcutaneous injection once every 4 weeks.2

Safety profile of ILARIS in CAPS3

  • In the β-Confident Registry, the largest documented CAPS cohort, ILARIS demonstrated a safety profile consistent with its clinical trial programme over 5 years.3

  • In general, the incidence of adverse events in each dose group of ILARIS increased with age (<4 to <65 years).4

  • 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 group.4

5-year safety profile of ILARIS in the β-Confident Registry3‡

  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%)§  

ILARIS has a convenient 8-weekly dosing schedule, with patients able to receive treatment at home2

Text reading 'once every 8 weeks'

In CAPS, ILARIS is administered as a subcutaneous injection once every 8 weeks.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.3

§One death was reported due to metastatic rectal adenocarcinoma in a 76-year-old patient.3

Indications2

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

  • Cryopyrin-associated periodic syndromes (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.
  • Tumour necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS).
  • Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
  • Familial Mediterranean fever (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. ILARIS® (canakinumab) Summary of Product Characteristics.     
  3. Kuemmerle-Deschner J et al. Pediatr Rheumatol 2015;13(Suppl 1):P3.
  4. Kuemmerle-Deschner JB et al. Abstract 1411 presented at 2018 ACR/ARHP Annual Meeting, 19–24 October 2018, Chicago, IL, USA.
ILA20-C008b September 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
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