Active Ingredient: Efgartigimod alfa
Efgartigimod alfa is indicated as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 10 milligrams efgartigimod alfa per kilogram of body weight, once weekly, over the duration of 4 weeks.
Regimen B: In case that patient weight is ≥ 120 kg, intravenous, 1,200 milligrams efgartigimod alfa, once weekly, over the duration of 4 weeks.
The recommended dose is 10 mg/kg as a 1-hour intravenous infusion to be administered in cycles of once weekly infusions for 4 weeks. Administer subsequent treatment cycles according to clinical evaluation. The frequency of treatment cycles may vary by patient.
In the clinical development program, the earliest time to initiate a subsequent treatment cycle was 7 weeks from the initial infusion of the previous cycle. The safety of initiating subsequent cycles sooner than 7 weeks from the start of the previous treatment cycle has not been established.
In patients weighing 120 kg or more, the recommended dose is 1,200 mg per infusion.
If a scheduled infusion is not possible, treatment may be administered up to 3 days before or after the scheduled time point. Thereafter, the original dosing schedule should be resumed until the treatment cycle is completed. If a dose needs to be delayed for more than 3 days, the dose should not be administered to ensure two consecutive doses are given with an interval of at least 3 days.
It should only be administered via intravenous infusion. Do not administer as an intravenous push or bolus injection.
In case of infusion reactions, the infusion can be either temporarily discontinued or slowed down.
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