Fidanacogene elaparvovec

Therapeutic indications

Fidanacogene elaparvovec is indicated for:

Moderate to severe hemophilia B

Population group: men, only adults (18 - 65 years old)

Fidanacogene elaparvovec is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who:

Currently use factor IX prophylaxis therapy, or
Have current or historical life-threatening hemorrhage, or
Have repeated, serious spontaneous bleeding episodes, and,
Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an approved test.

Select patients for therapy based on a diagnostic for fidanacogene elaparvovec.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

5 × 10¹¹ vector genomes per kg of body weight once

Contraindications

Fidanacogene elaparvovec is contraindicated in the following cases:

Pregnancy

Lactation

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