- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
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)
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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
| Moderate to severe plaque psoriasis |
|---|
|
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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.
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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 safety profile in children matches that of 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 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)
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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 | ||
| 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 | ||
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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
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Changes
Changes
