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Click here for BeneFIX® (nonacog alfa) Prescribing Information.  Adverse event reporting information can be found at the bottom of the page.

BeneFIX can be given as on-demand treatment or as prophylaxis

On-demand treatment1

The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dl (range from 0.4 to 1.4 IU/dl) in patients ≥12 years.

The required dose is determined using the following formula: number of factor IX IU required = body weight (kg) x desired factor IX increase (% or IU/dl) x reciprocal of observed recovery.

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
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In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in percentage of normal or in IU/dl) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:

Degree of haemorrhage / Type of surgical procedure

Factor IX level required (%) or (IU/dl)

Frequency of doses (hours) / Duration of therapy (days)

Haemorrhage

Early haemarthrosis, muscle bleeding or oral bleeding

20–40

Repeat every 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.

More extensive haemarthrosis, muscle bleeding or haematoma

30–60

Repeat infusion every 24 hours for 3–4 days or more until pain and acute disability are resolved.

Life-threatening haemorrhage

60–100

Repeat infusion every 8–24 hours until threat is resolved.

Surgery

Minor, including tooth extraction

30–60

Every 24 hours, at least 1 day, until healing is achieved.

Major

80–100 (pre- and post-operative)  

Repeat infusion every 8–24 hours until adequate wound healing, then therapy for at least another
7 days to maintain a factor IX activity of 30% to 60% (IU/dL)

Adapted from BeneFIX (nonacog alfa) Summary of Product Characteristics.1

Prophylaxis1

BeneFIX may be administered for long-term prophylaxis against bleeding in patients with haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for PTPs was 40 IU/kg (range 13–78 IU/kg) at intervals of 3–4 days.1

In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.

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Find out about flexible dosing & dosing optimisation with BeneFIX

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Find out about administration & reconstitution of BeneFIX

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Reference
  1. BeneFIX (nonacog alfa) Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/6157/smpc.
PP-BEN-GBR-0392. March 2021

Find out about BeneFIX efficacy 

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Educational materials for children with Haemophilia

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PP-PFE-GBR-2688. December 2020

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