Indications

IDELVION is indicated for the prophylaxis and treatment of bleeding in patients with haemophilia B (congenital factor IX deficiency) including treatment and prevention of bleeding in surgical settings.5

Please refer to the SPC for full details on any special warnings and precautions for use.

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Efficacy

In the phase 3 registration study, the median AsBR was zero both for subjects ≥12 years receiving 7-day (n=21, IQR 0.00-0.00) and 14-day (n=21, IQR 0.00-1.00) prophylactic treatment (within subject comparison).2

In the phase 3b extension study, the median AsBR was zero both of subjects ≥12 years receiving 7-day (n=21, IQR 0.00-1.67) and >18 years receiving 21-day (n=11, IQR 0.00-0.45) prophylactic treatment. For subjects ≥12 years receiving 14-day prophylactic treatment, the median AsBR was 0.37 (n=40, IQR 0.00-1.68).

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Dosing and administration

Available in 4 vial sizes5 for flexibility and efficiency.

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Tolerability

IDELVION is well tolerated5

  • IDELVION uses albumin fusion technology to extend half-life1
  • Albumin has a well-established tolerability profile, a low potential for immunogenic reactions and well-known mechanism of clearance1

Inhibitor development was reported in an ongoing clinical study with previously untreated patients (PUPs). Inhibitor development has been observed in previously treated patients (PTPs) in the post-marketing experience with IDELVION. There are insufficient data to provide information on inhibitor incidence in PTPs and PUPs.5 Please refer to the SPC for full details on special warnings and precautions for use.

Table showing adverse events associated with IDELVION

Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

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