IDELVION

  • Demonstrates FIX levels above 5% for 14 days at 75 IU/kg providing patients ≥12 years with protection from bleeding episodes.1
  • Demonstrates mean steady-state FIX trough level of 7.6% in patients >18 years when administered every 21 days at a median dose of 100 IU/kg.2
  • Effective treatment and prevention of bleeding episodes in adults and children.3,4
  • Effective in perioperative management.5

IDELVION – indication in haemophilia B6

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.6

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

Dosing and administration

IDELVION can offer patients ≥12 years flexibility with their infusion regimen

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IDELVION – Dosing and administration6

  • The reconstituted preparation should be injected intravenously at a rate comfortable for the patient.
  • Maximum infusion rate is 5 ml per minute.

See IDELVION SPC for full dosing guidance.

Dosing in prophylaxis

Prophylaxis in adult, adolescent and paediatric patients6

  • Adult and adolescent patients ≥12 years of age:
    – 35–50 IU/kg once weekly.
    – Once well-controlled appropriate patients can dose at up to 75 IU/kg on an interval of up to 14 days. For patients >18 years, further extension of the treatment interval may be considered.
  • Paediatric patients <12 years of age:
    – 35–50 IU/kg once weekly.

See IDELVION SPC for full dosing guidance.

Dosing in on demand

On demand treatment6

Dosing is based on the following empirical finding:

  • One International Unit (IU) factor IX per kg body weight is expected to increase the circulating level of factor IX by an average of:
    -1.3 IU/dL (1.3 % of normal) in patients ≥12 years of age.
    -1.0 IU/dL (1.0 % of normal) in patients <12 years of age.

See IDELVION SPC for full dosing guidance.

In patients <12 years of age6

For an incremental recovery of 1 IU/dL per 1 IU/kg:

  • Required dose (IU) = body weight (kg) x desired factor IX rise (IU/dL) x 1 dL/kg

Dosing example:

  • A 20 kg patient with severe haemophilia B requiring a peak level of 50% of normal

Dose = 20 kg x 50 IU/dL x 1 dL/kg
= 1000 IUs

See IDELVION SPC for full dosing guidance.

In patients ≥12 years of age6

For an incremental recovery of 1.3 IU/dL per 1 IU/kg:

  • Required dose (IU) = body weight (kg) x desired factor IX rise (IU/dL) x 0.77 dL/kg

Dosing example:

  • A 80 kg patient with severe haemophilia B requiring a peak level of 50% of normal

Dose = 80 kg x 50 IU/dL x 0.77 dL/kg
= 3080 IUs

See IDELVION SPC for full dosing guidance.

Dosing in surgery

In the case of haemorrhagic events, FIX activity should not fall below the given plasma activity level (in % of normal or in IU/dl) in the corresponding period as detailed.6

See IDELVION SPC for full dosing guidance.

Type of procedure FIX level required (%) (IU/dl) Frequency / duration of therapy
Minor surgery (including uncomplicated tooth extraction) 50–80 (pre- and postoperative) Single dose may be sufficient for a majority of minor surgeries. If needed, maintenance dose can be provided after 24–72 hours until bleeding stops and healing is achieved.
Major surgery 60–100 (pre- and postoperative) Repeat every 24–72 hours for the first week, and then maintenance dose 1–2 times per week until bleeding stops and healing is achieved.

Tolerability

IDELVION is well tolerated6

IDELVION uses albumin fusion technology to extend half-life.7

Albumin has a well-established tolerability profile, a low potential for immunogenic reactions, and well-known mechanism of clearance.7

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.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).

Storage

  • No need to refrigerate. Idelvion can be stored at room temperature (2–25°C). Do not store above 25°C. Do not freeze.6
  • Idelvion (not reconstituted) can be stored for up to 3 years from manufacture6