Active Ingredient: Efgartigimod alfa
Efgartigimod alfa is indicated as monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 1,000 milligrams efgartigimod alfa, once weekly, over the duration of 3 to 6 months.
The first 4 injections must be administered either by or under the supervision of a healthcare professional. Subsequent injections 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 administered subcutaneously as once-weekly injections.
Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation. In case of worsening of symptoms, administration of once-weekly injections should be resumed.
For those patients transitioning from their current CIDP therapies, efgartigimod alfa treatment should preferably be initiated before the clinical effect of these prior therapies starts to decrease.
Clinical response is usually achieved within 3 months of initiation of treatment with efgartigimod alfa subcutaneous. Clinical evaluation should be considered 3 to 6 months after treatment initiation to assess the treatment effect and at regular intervals thereafter.
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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