Active Ingredient: Spesolimab
Spesolimab is indicated for the treatment of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 900 milligrams spesolimab, one dose, over the duration of 1 week. Afterwards, intravenous, 900 milligrams spesolimab, one dose.
The recommended dose for GPP flare treatment in adults is a single dose of 900 mg administered as an intravenous infusion. If flare symptoms persist, an additional 900 mg dose may be administered 1 week after the initial dose.
Clinical data for treatment of subsequent flares is very limited.
Clinical data for concomitant use of other GPP treatments with spesolimab is limited. Spesolimab should not be used in combination with other GPP treatments, e.g. systemic immunosuppressants, to treat a flare.
For:
Regimen A: In case that patient weight is ≥ 30 kg and patient weight is < 40 kg, intravenous, 450 milligrams spesolimab, one dose, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 30 kg and patient weight is < 40 kg, intravenous, 450 milligrams spesolimab, one dose.
Regimen B: In case that patient weight is ≥ 40 kg, intravenous, 900 milligrams spesolimab, one dose, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 40 kg, intravenous, 900 milligrams spesolimab, one dose.
The recommended dose for GPP flare treatment in adults and adolescents from 12 years of age and weighing at least 40 kg is a single dose of 900 mg administered as an intravenous infusion. If flare symptoms persist, an additional 900 mg dose may be administered 1 week after the initial dose.
Spevigo has not been studied in patients weighing less than 40 kg. Based on pharmacokinetic modelling and simulation, the recommended dose for adolescents from 12 years of age weighing ≥30 and <40 kg is a single dose of 450 mg administered as an intravenous infusion. If flare symptoms persist, an additional 450 mg dose 3 may be administered 1 week after the initial dose.
Clinical data for treatment of subsequent flares is very limited.
Clinical data for concomitant use of other GPP treatments with spesolimab is limited. Spesolimab should not be used in combination with other GPP treatments, e.g. systemic immunosuppressants, to treat a flare.
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