Reliable efficacy when you and your patients need it most^1,2

Prophylaxis

Prophylactic treatment in PTPs
	reduction in ABR vs on-demand In PTPs. ReFacto® prophylaxis is more effective at preventing bleeds than on-demand treatment, with an 85% reduction of bleeds per year (median ABR: 3.4; n=154) achieved with prophylactic treatment3

On-demand treatment

On-demand treatment in PTPs
	of 10,882 bleeding episodes were treated effectively with only 1 infusion (n=113)1,2
On-demand treatment in PUPs
	of 2,715 bleeding episodes were treated effectively with only 1 infusion (n=101)1,2
Surgery
	of infusions administered were rated as excellent or good by the surgeon and treating physician (38 patients; 48 surgical procedures; 496 infusions during or after surgery)1,*

ReFacto AF^® is manufactured using the same cell line as ReFacto⁴ and is pharmacokinetics-equivalent to ReFacto^®5, so it is expected to behave in the same way.

*Excellent rating: achievement of comparable haemostasis to that expected after similar surgery in a non-haemophilic patient. Good rating: prolonged time to haemostasis with somewhat increased bleeding compared with that expected after similar surgery in a non-haemophilic patient.¹

Safety

A favourable safety profile⁵

The most common adverse reactions reported in pooled clinical trials with 715 subjects (591 PTPs, 124 PUPs)⁵:

• Factor VIII inhibitors in PUPs, headache, cough, arthralgia and pyrexia – very common (≥10%)
• Factor VIII inhibitors in PTPs - uncommon (>0.1 to <1%). Decreased appetite, dizziness, haemorrhage, haematoma, diarrhoea, vomiting, abdominal pain, nausea, urticaria, rash, pruritus, myalgia, chills, catheter-site-related reaction, antibody test positive and anti-factor VIII antibody test positive – common (≥1% to <10%)

Inhibitor formation

PTPs^1,3,6–8

Switching from recombinant or plasma-derived factor to ReFacto AF® did not significantly increase the risk of inhibitor formation.^3,8

PUPs⁶

References

1. Lusher JM et al. The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia. Haemophilia 2003;9:38–49.

2. Lusher JM and Roth DA. The safety and efficacy of B-domain deleted recombinant factor VIII concentrates in patients with severe haemophilia A: an update. Haemophilia 2005;11:292–293.

3. Parra Lopez R et al. Prospective surveillance study of haemophilia A patients switching from moroctocog alfa or other factor VIII products to moroctocog alfa albumin-free cell culture (AF-CC) in usual care settings. Thromb Haemost. 2015;114(4):676–684.

4. Kelley B et al. An improved manufacturing process for Xyntha/ReFacto AF. Haemophilia 2010;16(5):717–725.

5. Refacto AF^® (moroctocog alfa)Summary of Product Characteristics RF_14 : Accessed October 2020.

6. Courter SG and Bedrosian CL. Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients. Semin Hematol 2001;38(2):44–51.

7. Recht M et al. Clinical evaluation of moroctocog alfa (AF-CC), a new generation of B-domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: demonstration of safety, efficacy, and pharmacokinetic equivalence to full-length recombinant factor VIII. Haemophilia 2009;15(4):869–880.

8. Hay CR et al. The incidence of factor VIII inhibitors in severe haemophilia A following a major switch from full-length to B-domain-deleted factor VIII: a prospective cohort comparison. Haemophilia 2015;21(2):219–222.

ABR = annualised bleeding rate; BU = Bethesda units; PTP = previously treated patient; PUP = previously untreated patient.

PP-REF-GBR-0226. October 2020