Pharmacokinetics in children
The steady-state exposure (AUC and Cmax) in children (dose 40 or 60 mg/day in 2 doses) is similar to the steady-state exposure in adult patients (dose 60 mg/day in 2 doses) (SmPC)
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
| Moderate to severe plaque psoriasis |
- Oral
-
≥ 6 years
and
20
up to
50 kg
-
Day 1:
10
mg/day
in 1
dose Day 2 up to day 4: increase the initial dose daily with 10 mg increments up to 40 mg/day on day 4. Divide the daily dose in 2 doses.
-
≥ 6 years
and
≥ 50 kg
-
Day 1:
10
mg/day
in 1
dose Day 2 up to day 6: increase the initial dose daily with 10 mg increments up to 60 mg/day on day 6. Divide the daily dose in 2 doses.
|
Renal impaiment in children > 3 months
- Mild or moderate renal impairment: no dose adjustment necessary
- Severe renal impairment (creatinine clearance less than 30 ml/min): reduce maintenance dose by half
When titrating the dose, it is recommended to skip the second dose on that day.
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 safety profile in children matches that of 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 in children
Regularly monitor the body weight of children with a low or borderline low BMI at the start of and during treatment. Consider discontinuing treatment in these children in the event of unexplained and clinically significant weight loss.(SmPC Otezla)
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
|
|
|
|
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
|
|
|
|
L04AC08
|
|
|
|
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
|
References
-
Amgen Europe B.V., SmPC Otezla (EU/1/14/981/004) Rev 23, 22-10-2024, www.geneesmiddelinformatiebank.nl
-
Amgen Europe B.V., SmPC Otezla (EU/1/14/981/004) Rev 24, 16-07-2025, www.geneesmiddelinformatiebank.nl
Therapeutic Drug Monitoring
Overdose