Active Ingredient: Adalimumab
Adalimumab is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≥ 4 and patient weight is ≥ 15 kg and patient weight is < 30 kg
Subcutaneous, 20 milligrams adalimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 20 milligrams adalimumab, once every 2 weeks.
Regimen B, in case that patient age in years is ≥ 4 and patient weight is ≥ 30 kg
Subcutaneous, 40 milligrams adalimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 40 milligrams adalimumab, once every 2 weeks.
The recommended adalimumab dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table). Adalimumab is administered via subcutaneous injection.
Adalimumab Dose for Paediatric Patients with Plaque Psoriasis:
| Patient Weight | Dosing Regimen |
|---|---|
| 15 kg to <30 kg | Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose |
| ≥30 kg | nitial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose |
Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
If retreatment with adalimumab is indicated, the above guidance on dose and treatment duration should be followed.
The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
There is no relevant use of adalimumab in children aged less than 4 years for this indication.
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