Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Canakinumab

Generic name
Canakinumab
Brand name
ATC Code
L04AC08

Pharmacokinetics in children

Peak concentrations of canakinumab appeared between 2 and 7 days (Tmax) after a single subcutaneous administration of 150 mg or 2 mg/kg canakinumab in paediatric patients. The terminal half-life varied from 22.9 to 25.7 days; this was comparable to the pharmacokinetic properties seen in adults. Based on the population pharmacokinetics modelling analysis, the pharmacokinetics of canakinumab in children from 2 to < 4 years were comparable to those in patients aged 4 and older. The subcutaneous absorption rate was estimated to drop with age, appearing to be fastest in the youngest patients. Accordingly the Tmax was shorter (3.6 days) in younger SJIA patients (2-3 years) compared to older SJIA patients (12-19 years; Tmax 6 days). The bioavailability (AUCss) was not affected.

The pharmacokinetic properties are the same in paediatric patients with CAPS, TRAPS, HIDS/MKD, FMF and SJIA.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Systemic juvenile idiopathic arthritis (sJIA)
  • Subcutaneous
    • 2 years up to 18 years
      • 4 mg/kg/dose once every 4 weeks. Max single dose: 300 mg/dose.

      • Only on prescription by a specialist paediatrician who is familiar with using canakinumab for this indication.
Cryopyrin-associated periodic syndromes (CAPS)
  • Subcutaneous
    • 2 years up to 4 years and ≥ 7.5 kg
      • Initial dose: 4 mg/kg/dose, once only. Evaluate after 7 days; repeat the initial dose if necessary if there is insufficient clinical response..
      • Maintenance dose: (Dependent on the response to the starting dose) 4 - 8 mg/kg/dose once every 8 weeks.

      • Only on prescription by a specialist paediatrician who is familiar with using canakinumab for this indication

    • ≥ 4 years and 7.5 up to 15 kg
      • Initial dose: 4 mg/kg/dose, once only. Evaluate after 7 days; repeat the initial dose if necessary if there is insufficient clinical response..
      • Maintenance dose: (Dependent on the response to the starting dose) 4 - 8 mg/kg/dose once every 8 weeks.

      • Only on prescription by a specialist paediatrician who is familiar with using canakinumab for this indication

    • ≥ 4 years and 15 up to 40 kg
      • Initial dose: 2 mg/kg/dose, once only. Evaluate after 7 days; repeat the initial dose if necessary if there is insufficient clinical response. Evaluate after another 7 days; double the initial dose if necessary if there is insufficient clinical response to the repeated initial dose..
      • Maintenance dose: (Dependent on the response to the starting doses) 2 - 8 mg/kg/dose once every 8 weeks.

      • Only on prescription by a specialist paediatrician who is familiar with using canakinumab for this indication

    • ≥ 4 years and ≥ 40 kg
      • Initial dose: 150 mg/dose, once only. Evaluate after 7 days; repeat the initial dose if necessary if there is insufficient response. Evaluate again after 7 days; double the initial dose if necessary if there is insufficient response to the repeated initial dose..
      • Maintenance dose: (Dependent on the earlier response to the starting doses) 150 - 600 mg/dose once every 8 weeks.

      • Only on prescription by a specialist paediatrician who is familiar with using canakinumab for this indication.
TRAPS, HIDS/MKD and FMF
  • Subcutaneous
    • ≥ 2 years and 7.5 up to 40 kg
      • Initial dose: 2 mg/kg/dose, once only. Evaluation after 7 days, repeat starting dose if necessary in case of insufficient clinical response.
      • Maintenance dose: (Depending on response to starting dose) 2 - 4 mg/kg/dose once every 4 weeks.
    • ≥ 2 years and ≥ 40 kg
      • Initial dose: 150 mg/dose, once only. Evaluation after 7 days, repeat starting dose if necessary in case of insufficient clinical response.
      • Maintenance dose: (Depending on response to starting dose) 150 - 300 mg/dose once every 4 weeks.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The side effects profile in children does not differ from adults.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Selective immunosuppressants
L04AA24
L04AA32
L04AA13
L04AA02
L04AA06
L04AA31
L04AA04
L04AA44
Other immunosuppressants
L04AX01
L04AX03
Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB04
L04AB01
L04AB06
L04AB02
Interleukin inhibitors
L04AC03
L04AC02
L04AC13
L04AC19
L04AC10
L04AC22
L04AC07
L04AC05
Calcineurin inhibitors
L04AD01
L04AD02
Sphingosine-1-phosphate (S1P) receptor modulators
L04AE01
Janus-associated kinase (JAK) inhibitors
L04AF02
L04AF02
L04AF08
L04AF01
Monoclonal antibodies
L04AG04
Mammalian target of rapamycin (mTOR) kinase inhibitors
L04AH02
L04AH01
Complement inhibitors
L04AJ01
L04AJ02
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

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Reference

  1. Novartis Europharm Limited, Spc Ilaris (EU/1/09/564/003) 25-02-2020, www.ema.europa.eu

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Changes

Changes