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 the 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.
For:
Subcutaneous, 1,000 milligrams efgartigimod alfa, once weekly, over the duration of 4 weeks.
The first treatment cycle and first administration of the second treatment cycle must be administered either by or under the supervision of a healthcare professional. Subsequent treatment should be administered by a healthcare professional or may be administered at home by a patient or caregiver after adequate training in the subcutaneous injection technique.
The recommended dose is 1 000 mg to be administered subcutaneously in cycles of once weekly injections for 4 weeks. Subsequent treatment cycles should be administered 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.
For patients currently receiving efgartigimod alfa intravenously, the solution for subcutaneous injection may be used as an alternative. It is recommended to switch between formulations at the start of a new treatment cycle. No safety and efficacy data in patients switching formulations during the same cycle is available.
An interval of at least 3 days should be observed between two consecutive administrations. When administrations cannot be done at the scheduled time point, they should be performed as soon as possible and at least 3 days ahead of the following administration. If there are less than 3 days to the next administration, the missed dose should be skipped and the next dose should be administered at the scheduled time point.
During the initial administrations of efgartigimod alfa, appropriate treatment for injection and hypersensitivity-related reactions should be readily available. The recommended injection sites (abdomen) should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red or hard. The injection may be slowed if the patient experiences discomfort.
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