Cryopyrin associated periodic syndromes (CAPS)

Active Ingredient: Canacinumab

Indication for Canacinumab

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Canakinumab is indicated for the treatment of 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.

For this indication, competent medicine agencies globally authorize below treatments:

2-4 mg/kg once every 8 weeks

Route of admnistration

Subcutaneous

Defined daily dose

2 - 4 mg per kg of body weight

Dosage regimen

From 2 To 4 mg per kg of body weight once every 56 day(s)

Detailed description

Cryopyrin associated periodic syndromes (CAPS): Adults, adolescents and children aged 2 years and older

The recommended starting dose of canakinumab for cryopyrin associated periodic syndromes (CAPS) patients is:

Adults, adolescents and children ≥4 years of age:

  • 150 mg for patients with body weight >40 kg
  • 2 mg/kg for patients with body weight ≥15 kg and ≤40 kg
  • 4 mg/kg for patients with body weight ≥7.5 kg and <15 kg

Children 2 to <4 years of age:

  • 4 mg/kg for patients with body weight ≥7.5 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 should 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 should 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 treatment response is subsequently achieved, maintaining the intensified dosing regimen of 8 mg/kg every 8 weeks should 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.

Dosage considerations

The following are suitable injection sites: upper thigh, abdomen, upper arm or buttocks. It is recommended to select a different injection site each time the product is injected to avoid soreness. Broken skin and areas which are bruised or covered by a rash should be avoided. Injection into scar tissue should be avoided as this may result in insufficient exposure to canakinumab.

Active ingredient

Canacinumab

Canacinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype. Canacinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators.

Read more about Canacinumab

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