Dosing

Dosing that’s as individual as your patients1–3

No two days are the same. No two patients are the same. BeneFIX® offers frequent, flexible dosing so your patients are covered for everyday life1,4,5

 


Patients may vary in their response to factor IX, demonstrating different half-lives and recoveries1,2
 
Shorter dose intervals or higher doses may be necessary to deliver adequate coverage based on patient’s bleeding phenotype, levels of physical activity, and preference regarding convenience and adherence1–3

BeneFIX® offers frequent, flexible dosing1
 
BeneFIX® comes in a range of vial sizes, so you can individualise factor IX coverage for your patients1
BeneFIX® can be given as on-demand treatment or as prophylaxis1
BeneFIX® offers patients storage flexibility through room temperature storage (<30ºC)1

So your patients are covered for everyday life1,4,5

 

 

Dosing and administration1

BeneFIX® is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile 0.234% sodium chloride solution.

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.

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 severe 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.

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

 

References

1. BeneFIX® (nonacog alfa) Summary of Product Characteristics. June 2017.

2. Shapiro AD et al. Use of pharmacokinetics in the coagulation factor treatment of patients with haemophilia. Haemophilia 2005;11:571–582.

3. Berntorp E and Andersson NG. Prophylaxis for Hemophilia in the Era of Extended Half-Life Factor VIII/Factor IX Products. Semin Thromb Hemost 2016;42:518–525.

4. Mahdi AJ et al. Role of enhanced half-life factor VIII and IX in the treatment of haemophilia. Br J Haematol. 2015;169:768–776.

5. Collins PW, et al. Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia. Haemophilia. 2011;17:2–10.

 

IU = international units; PTP = previously treated patient.

 

PP-BEN-GBR-0233. October 2018