Active Ingredient: Valoctocogene roxaparvovec
Valoctocogene roxaparvovec is indicated for the treatment of severe haemophilia A (congenital factor VIII deficiency) in adult patients without a history of factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 60,000,000,000,000 copies valoctocogene roxaparvovec per kilogram of body weight, one dose.
The recommended dose is 6 × 1013 vector genomes per kilogram (vg/kg) body weight, administered as a single intravenous infusion.
When discontinuing factor VIII concentrates/haemostatic agents, physicians should consider the following:
Do not infuse as an intravenous push or bolus.
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