Active Ingredient: Adalimumab
Adalimumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Subcutaneous, 160 milligrams adalimumab, every 2 weeks, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 80 milligrams adalimumab, every 2 weeks, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 40 milligrams adalimumab, once weekly.
Regimen B
Subcutaneous, 160 milligrams adalimumab, every 2 weeks, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 80 milligrams adalimumab, every 2 weeks, one dose, over the duration of 2 weeks.
The recommended adalimumab dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day). Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day).
Antibiotics may be continued during treatment with adalimumab if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with adalimumab.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Should treatment be interrupted, adalimumab 40 mg every week or 80 mg every other week may be reintroduced.
The benefit and risk of continued long-term treatment should be periodically evaluated.
For:
In case that patient weight is ≥ 30 kg
Subcutaneous, 80 milligrams adalimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 40 milligrams adalimumab, once every 2 weeks.
There are no clinical trials with adalimumab in adolescent patients with HS.
The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation.
The recommended adalimumab dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection.
In adolescent patients with inadequate response to adalimumab 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Antibiotics may be continued during treatment with adalimumab if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with adalimumab.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Should treatment be interrupted, adalimumab may be re-introduced as appropriate.
The benefit and risk of continued long-term treatment should be periodically evaluated.
There is no relevant use of adalimumab in children aged less than 12 years in this indication.
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