IDELVION – A FACTOR FOR FREEDOM

  • Delivers high* and sustained FIX levels1
  • Effective prevention and control of bleeding episodes in adults and children2,3
  • Effective in perioperative management4

*FIX levels above 5% for 14 days at 75 IU/Kg.

IDELVION – indication in haemophilia B5

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

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

Dosing and administration

IDELVION can offer patients flexibility with their infusion regimes

Up to 14 days protection with one injection for patients with haemophilia B.2,5

Click here for storage information

*Patients who are well-controlled on an every 7 days regimen might be treated with up to 75 IU/kg on an interval of up to 14 days.

IDELVION – Dosing and administration5

  • 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 and paediatric patients5

  • For long-term prophylaxis, the licensed doses are 35 to 50 IU/kg once weekly
  • Some patients who are well-controlled on a once-weekly regimen might be treated with up to 75 IU/kg on an interval of 10 or 14 days
  • In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary

Dosing in on demand

On demand treatment5

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

In patients <12 years of age5

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

  • Dose (IU) = body weight (kg) x desired factor IX increase (IU/dL) x 1 dL/kg

Dosing example:

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

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

In patients ≥12 years of age5

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

  • Dose (IU) = body weight (kg) x desired factor IX increase (IU/dL) x 0.77 dL/kg

Dosing example:

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

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

Dosing in surgery

In the case of haemorrhagic events, FIX activity should not fall below the given plasma activity level (in % or normal or in IU/dl) in the corresponding period as detailed.5

Type of procedure FIX level required (%) (IU/dl) Frequency / duration of therapy
Minor surgery (including uncomplicated tooth extraction) 50–80 (initial level) 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 (initial level) 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 tolerated1-5

IDELVION uses albumin fusion technology to extend half-life.6

Albumin has a well-established tolerability profile, a low potential for immunogenic reactions, and well-known mechanism of clearance.6

One previously untreated patient (PUP) from the ongoing clinical trial developed a high titre inhibitor against FIX. There are insufficient data to provide information on inhibitor incidence in PUPs.5

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

Storage

  • No need to refrigerate
  • Idelvion (not reconstituted) can be stored for up to 3 years

†Do not store above 25°C and do not freeze.

IDELVION 250 IU  
IDELVION 500 IU
IDELVION 1000 IU  
IDELVION 2000 IU