Active Ingredient: Pegunigalsidase alfa
Pegunigalsidase alfa is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1 milligrams pegunigalsidase alfa per kilogram of body weight, once every 2 weeks.
The recommended dose of pegunigalsidase alfa is 1 mg/kg of body weight administered once every two weeks.
For the initial 3 months (6 infusions) of treatment with pegunigalsidase alfa, pre-treatment regimen should be preserved with stepwise discontinuation of pre-treatment based on appropriate tolerability of the patients.
Safety and efficacy of pegunigalsidase alfa in patients older than 65 years have not been evaluated and no alternative dose regimens can be recommended for these patients. Elderly patients may be treated with the same dose as other adult patients.
For intravenous infusion use only.
Pegunigalsidase alfa must not be infused in the same intravenous line with other products.
The patient should be observed for infusion-related reactions (IRRs) for two hours after the infusion.
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