Active Ingredient: Adalimumab
Adalimumab is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≥ 6 and patient weight is < 40 kg
Subcutaneous, 80 milligrams adalimumab, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 40 milligrams adalimumab, once every 2 weeks.
Regimen B, in case that patient age in years is ≥ 6 and patient weight is ≥ 40 kg
Subcutaneous, 160 milligrams adalimumab, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 80 milligrams adalimumab, once every 2 weeks.
The recommended dose of adalimumab for patients from 6 to 17 years of age with ulcerative colitis is based on body weight. Adalimumab is administered via subcutaneous injection.
Adalimumab Dose for Paediatric Patients with Ulcerative Colitis:
| Patient Weight | Induction Dose | Maintenance Dose Starting at Week 4* |
|---|---|---|
| <40 kg | • 80 mg at Week 0 (given as two 40 mg injections in one day) and • 40 mg at Week 2 (given as one 40 mg injection) | • 40 mg every other week |
| ≥40 kg | • 160 mg at Week 0 (given as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and • 80 mg at Week 2 (given as two 40 mg injections in one day) | • 80 mg every other week |
* Paediatric patients who turn 18 years of age while on adalimumab should continue their prescribed maintenance dose.
Continued therapy beyond 8 weeks should be carefully considered in patients not showing signs of response within this time period.
There is no relevant use of adalimumab in children aged less than 6 years in this indication.
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