Active Ingredient: Adalimumab
Adalimumab is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
20 - 160 mg
From 20 To 160 mg once every 14 day(s)
40 mg
The recommended dose of adalimumab for patients with Crohn’s disease from 6 to 17 years of age is based on body weight (Table). Adalimumab is administered via subcutaneous injection.
Adalimumab Dose for Paediatric Patients with Crohn’s disease:
| Patient Weight | Induction Dose | Maintenance Dose Starting at Week 4 |
|---|---|---|
| <40 kg | 40 mg at week 0 and 20 mg at week 2. In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 80 mg at week 0 and 40 mg at week 2 | 20 mg every other week |
| ≥40 kg | 80 mg at week 0 and 40 mg at week 2. In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 160 mg at week 0 and 80 mg at week 2 | 40 mg every other week |
Patients who experience insufficient response may benefit from an increase in dosage:
Continued therapy should be carefully considered in a subject not responding by week 12.
There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Adalimumab may be available in other strengths and/or presentations depending on the individual treatment needs.
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