Ilaris

For CAPS, TRAPS, HIDS/MKD, FMF and Still’s disease, the treatment is to be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication. For gouty arthritis, the physician needs to be experienced in the use of biologics and Ilaris is to be administered by a healthcare professional.

5 kg This is administered every eight weeks as a single dose via subcutaneous injection. For patients with a starting dose of 150 mg or 2 mg/kg, if a satisfactory clinical response (resolution of rash and other generalised inflammatory symptoms) has not been achieved 7 days after treatment start, a second dose of canakinumab at 150 mg or 2 mg/kg can be considered.

If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg or 4 mg/kg every 8 weeks needs to be maintained. If a satisfactory clinical response has not been achieved 7 days after this increased dose, a third dose of canakinumab at 300 mg or 4 mg/kg can be considered.

If a full treatment response is subsequently achieved, maintaining the intensified dosing regimen of 600 mg or 8 mg/kg every 8 weeks is to be considered, based on individual clinical judgement. For patients with a starting dose of 4 mg/kg, if a satisfactory clinical response has not been achieved 7 days after treatment start, a second dose of canakinumab 4 mg/kg can be considered.

If a full 4 treatment response is subsequently achieved, maintaining the intensified dosing regimen of 8 mg/kg every 8 weeks is to be considered, based on individual clinical judgement. Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.

5 kg and ≤ 40 kg This is administered every four weeks as a single dose via subcutaneous injection. If a satisfactory clinical response has not been achieved 7 days after treatment start, a second dose of canakinumab at 150 mg or 2 mg/kg can be considered.

If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) every 4 weeks needs to be maintained. CAPS in adults and children  4 years of age  15 kg Maintenance dose: 150 mg or 2 mg/kg every 8 weeks Additional dose of 150 mg or 2 mg/kg can be considered 150 mg or 2 mg/kg Additional dose of 300 mg or 4 mg/kg can be considered Maintenance dose 4 mg/kg every 8 weeks Additional dose of 4 mg/kg can be considered Satisfactory clinical response after 7 days?

Summary of the safety profile The most frequent adverse reactions were infections predominantly of the upper respiratory tract. No impact on the type or frequency of adverse reactions was seen with longer-term treatment. 4). 4). Tabulated list of adverse reactions Adverse reactions are listed according to MedDRA system organ class.

Within each system organ class, the adverse reactions are ranked by frequency category with the most common first. Frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 11 Table 1 Tabulated list of adverse reactions MedDRA System Organ Class Indications: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, gouty arthritis Infections and infestations Very common Respiratory tract infections (including pneumonia, bronchitis, influenza, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper respiratory tract infection) Ear infection Cellulitis Gastroenteritis Urinary tract infection Common Vulvovaginal candidiasis Nervous system disorders Common Dizziness/vertigo Gastrointestinal disorders Very common Upper abdominal pain 1 Uncommon Gastro-oesophageal reflux disease 2 Skin and subcutaneous tissue disorders Very common Injection site reaction Musculoskeletal and connective tissue disorders Very common Arthralgia 1 Common Musculoskeletal pain 1 Back pain 2 General disorders and administration site conditions Common Fatigue/asthenia 2 Investigations Very common Creatinine renal clearance decreased 1,3 Proteinuria 1,4 Leukopenia 1,5 Common Neutropenia 5 Uncommon Platelet count decreased 5 1 In SJIA 2 In gouty arthritis 3 Based on estimated creatinine clearance, most were transient 4 Most represented transient trace to 1+ positive urinary protein by dipstick 5 See further information below Still’s Disease (SJIA and AOSD) SJIA pooled analysis and AOSD A total of 445 SJIA patients aged 2 to < 20 years received canakinumab in clinical trials, including 321 patients aged 2 to < 12 years, 88 patients aged 12 to < 16 years, and 36 patients aged 16 to < 20 years.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Canakinumab is associated with an increased incidence of serious infections.

8). Physicians need to exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions which may predispose them to infections. Treatment of CAPS, TRAPS, HIDS/MKD, FMF and Still’s disease (SJIA and AOSD) Canakinumab must not be initiated or continued in patients during an active infection requiring medical intervention.

Treatment of gouty arthritis Canakinumab must not be administered during an active infection. 5). Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment.

The causal relationship of canakinumab to these events cannot be excluded. Tuberculosis screening In approximately 12% of CAPS patients tested with a PPD (purified protein derivative) skin test in clinical trials, follow-up testing yielded a positive test result while treated with canakinumab without clinical evidence of a latent or active tuberculosis infection.

It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis. Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection.

Particularly in adult patients, it is recommended that this evaluation includes a detailed medical history. g. tuberculin skin test, interferon gamma release assay or chest X-ray) are recommended to be performed in all patients (local recommendations may apply).

Patients must be monitored closely for signs and symptoms of tuberculosis during and after treatment with canakinumab. g. persistent cough, weight loss, subfebrile temperature) appear during canakinumab therapy. In the event of conversion from a negative to a positive PPD test, especially in high-risk patients, alternative means of screening for a tuberculosis infection can be considered.

1. 4).