Active Ingredient: Sutimlimab
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 39 kg and patient weight is ≤ 75 kg, intravenous, 6,500 milligrams sutimlimab, once weekly, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 39 kg and patient weight is ≤ 75 kg, intravenous, 6,500 milligrams sutimlimab, once every 2 weeks.
Regimen B: In case that patient weight is ≥ 75 kg, intravenous, 7,500 milligrams sutimlimab, once weekly, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 75 kg, intravenous, 7,500 milligrams sutimlimab, once every 2 weeks.
Patients should be vaccinated according to the most current local recommendations for patients with persistent complement deficiencies.
The recommended dose is based on body weight. For patients weighing 39 kg to less than 75 kg, the recommended dose is 6500 mg and for patients weighing 75 kg or more, the recommended dose is 7500 mg. Administer sutimlimab intravenously weekly for the first two weeks, with administration every two weeks thereafter. Sutimlimab should be administered at the recommended dose regimen time points, or within two days of these time points. Sutimlimab is intended for continuous use as chronic therapy only, unless the discontinuation of sutimlimab is clinically indicated.
If a dose is missed, the missed dose should be administered as soon as possible. If the duration after the last dose exceeds 17 days, therapy should be reinitiated with weekly administrations for the first two weeks followed by administration every two weeks thereafter.
It is for intravenous infusion only. Do not administer as an intravenous push or bolus.
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