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.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Systemic juvenile idiopathic arthritis (sJIA) |
|
|
| Cryopyrin-associated periodic syndromes (CAPS) |
- Subcutaneous
-
2 years
up to
4 years
and
≥ 7.5 kg
-
≥ 4 years
and
7.5
up to
15 kg
-
≥ 4 years
and
15
up to
40 kg
-
≥ 4 years
and
≥ 40 kg
|
| 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.
|
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.
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.
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.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
IMMUNOSUPPRESSANTS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| 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
|
Reference
-
Novartis Europharm Limited, Spc Ilaris (EU/1/09/564/003) 25-02-2020, www.ema.europa.eu
Therapeutic Drug Monitoring
Overdose