Dosing

Dosing that’s as individual as your patients1–3

No two days are the same. No two patients are the same. ReFacto AF® offers frequent, flexible dosing so your patients are covered for everyday life1–3

 


Patients may vary in their response to factor VIII, 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

ReFacto AF® offers frequent, flexible dosing1
 
ReFacto AF® comes in a range of vial sizes, so you can individualise factor VIII coverage for your patients1
ReFacto AF® can be given as on-demand treatment or as prophylaxis1

So your patients are covered for everyday life1-3

 

Dosing and administration1

ReFacto AF® is administered by intravenous infusion over several minutes after reconstitution of the lyophilised powder for injection with sodium chloride 9 mg/ml (0.9%) solution for injection (provided). The rate of administration should be determined by the patient's comfort level.

On-demand treatment1

The calculation of the required dose of factor VIII is based upon the empirical finding that 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl. The required dose is determined using the following formula:

Number of factor VIII IU required = body weight (kg) x desired VIII increase (% or IU/dl) x 0.5 (IU/kg per IU/dl), where 0.5 IU/kg per IU/dl represents the reciprocal of the recovery generally observed following infusions of factor VIII.

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 VIII activity should not fall below the given plasma 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 VIII 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 12-24 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 12-24 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 surgery including tooth extraction 30–60 Every 24 hours, at least 1 day, until healing is achieved.
Major surgery

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 VIII activity of 30% to 60% (IU/dL)

Adapted from ReFacto® (moroctocog alfa) Summary of Product Characteristics.1

Prophylaxis1

For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.

References

1. ReFacto AF® (moroctocog alfa) Summary of Product Characteristics. October 2019.

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, Andersson NG. Prophylaxis for hemophilia in the era of extended half-life factor VIII/factor IX products. Semin Thromb Hemost 2016;42:518–525.

IU = international units.

PP-REF-GBR-0177. October 2019