Skip to main content
SpringerLink
Log in

Octocog alfa, Plasma/Albumin-Free Method

  • Adis Drug Profile
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

▴ Octocog alfa, plasma/albumin-free method (octocog alfa-PFM) is a recombinant, human, full length, coagulation factor VIII that has been produced without the addition of human- or animal-derived plasma proteins, thereby virtually eliminating the risk of transmission of blood-borne pathogens.

▴ Octocog alfa-PFM is structurally and functionally very similar to a previously marketed, albumin-containing formulation of the same recombinant factor VIII.

▴ The haemostatic efficacy of octocog alfa-PFM was rated excellent or good in the acute treatment of most breakthrough bleeding episodes in adolescents or adults with moderately severe or severe haemophilia A who were receiving prophylaxis with octocog alfa-PFM and who had been previously treated with factor VIII.

▴ Most bleeding episodes resolved after one or two infusions of octocog alfa-PFM. Efficacy was similar regardless of the cause or site of the bleeding episode.

▴ Similar excellent or good haemostatic efficacy was observed with octocog alfa-PFM in previously treated children aged <6 years with haemophilia A and during perioperative use in patients with haemophilia A undergoing surgical or invasive dental procedures.

▴ Octocog alfa-PFM was well tolerated during clinical development and in the 15-month post-marketing period. There were very few adverse events and serious events were rare. The risk for developing inhibitors (antibodies) to factor VIII was very low.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

References

  1. Mannucci PM, Tuddenham EGD. The hemophilias: from royal genes to gene therapy. N Engl J Med 2001 Jun 7; 344: 1773–9

    Article  PubMed  CAS  Google Scholar 

  2. Santagostino E, Gringeri A, Mannucci PM. State of care for hemophilia in pediatric patients. Pediatric Drugs 2002; 4(3): 149–57

    PubMed  Google Scholar 

  3. Baxter Healthcare Corporation. ADVATE Octocog alfa (recombinant coagulation factor VIII): product monograph. 2004 Sep

  4. Bjorkman S, Berntorp E. Pharmacokinetics of coagulation factors: clinical relevance for patients with haemophilia. Clin Pharmacokinet 2001; 40(11): 815–32

    Article  PubMed  CAS  Google Scholar 

  5. National Hemophilia Foundation. MASAC recommendations concerning the treatment of hemophilia and other bleeding disorders. MASAC Document #151 [online]. Available from URL: http://www.hemophilia.org/research/masac/masacl51.pdf [Accessed 2005 Sep 10]

  6. United Kingdom Haemophilia Centre Doctor’s Organisation. Guidelines on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders. Haemophilia 2003 Jan; 9(1): 1–23

    Article  Google Scholar 

  7. ADVATE (octocog alfa): summary of product characteristics [online]. Available from URL: http://www.emea.eu.int/humandocs/Humans/EPAR/advate/advate.htm [Accessed 2005 Sep27]

  8. Baxter Healthcare SA. Baxter announces European Union expanded approval of ADVATE for use in children with haemophilia A less than six years old [media release; online]. 2004 Dec 23. Available from URL: http://www.baxter.com [Accessed 2005 Nov 25]

  9. European Medicines Agency. Advate. European public assessment report: scientific discussion [online]. Available from URL: http://www.emea.eu.int/humandocs/Humans/EPAR/advate/advate.htm [Accessed 2005 Sep 10]

  10. Ewenstein BM, Collins P, Tarantino MD, et al. Hemophilia therapy innovation: development of an advanced category recombinant factor VIII by a plasma/albumin-free method. Proceedings of a Special Symposium at the XIXth Congress of the International Society on Thrombosis and Haemostasis, July 12–18, 2003, Birmingham, UK. Semin Hematol 2004 Apr; 41 (2 Suppl. 2): 1–16; discussion 16-18

    PubMed  CAS  Google Scholar 

  11. Parti R, Schoppmann A, Lee H, et al. Stability of lyophilized and reconstituted plasma/albumin-free recombinant human factor VIII (ADVATE rAHF-PFM). Haemophilia 2005; 11: 492–6

    Article  PubMed  CAS  Google Scholar 

  12. Tarantino MD, Collins PW, Hay CR, et al. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia 2004 Sep; 10(5): 428–37

    Article  PubMed  CAS  Google Scholar 

  13. Liesner R, Shapiro A, Blanchette V, et al. Pharmacokinetics, safety and efficacy of ADVATE rAHF-PFM in previously treated patients less than 6 years old [poster]. 20th Congress of the International Society on Thrombosis and Haemostasis; 2005 Aug 6–12; Sydney

  14. Négrier C, Shapiro A, Pabinger I, et al. Clinical efficacy and safety evaluation of ADVATE antihemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM) during surgical and invasive procedures [poster]. 20th Congress of the International Society on Thrombosis and Haemostasis; 2005 Aug 6–12; Sydney

  15. Sclar DA, Evans MA, Skaer TL, et al. Economic and epidemiological modelling of full-length antihaemophilic factor (recombinant), plasma/albumin-free method, in previously treated patients with haemophilia A: comparison with B-domain deleted rFVIII, and value of potential viral transmission reduction due to plasma/albumin-free status. Drugs RD 2005; 6(3): 149–56

    Article  CAS  Google Scholar 

  16. Gomperts ED, Ewenstein BM, O’Banion ME, et al. The growing body of evidence on safety profile of ADVATE antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM) [poster]. 2004 Annual Meeting of the American Society of Hematology; 2004 Dec 4–7; San Diego (CA)

  17. Gomperts E. ADVATE inhibitor risk profile: 18 months post-licensure. In: Scharrer I, Schramm W, editors. 35th Hemophilia Symposium Hamburg 2004. Heidelberg: Springer-Verlag. In press

  18. Ewenstein BM, Gomperts ED, Pearson S, et al. Inhibitor development in patients receiving recombinant factor VIII (Recombinate rAHF/Bioclate): a prospective pharmacovigilance study. Haemophilia 2004 Sep; 10(5): 491–8

    Article  PubMed  CAS  Google Scholar 

  19. Baxter Healthcare Corporation. ADVATE antihemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM): US prescribing information [online]. Available from URL: http://www.advate.com [Accessed 2005 Oct 27]

  20. Baxter Healthcare Corporation. FDA approves Baxter’s ADVATE for the treatment of hemophilia A [media release; online]. 2003 Jul 25. Available from URL: http://www.baxter.com [Accessed 2005 Nov 25]

  21. Baxter Healthcare Pty Ltd. Baxter receives marketing approval from Australia’s Therapeutic Goods Administration for ADVATE to treat haemophilia A [media release; online]. 2005 Apr 14. Available from URL: http://www.baxter.com [Accessed 2005 Nov 25]

Download references

Acknowledgements

At the request of the journal, Baxter International provided a non-binding review of this article.

Author information

Authors and Affiliations

  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland, 1311, New Zealand

    Paul L. McCormack & Greg L. Plosker

Authors
  1. Paul L. McCormack
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Greg L. Plosker
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Paul L. McCormack.

Rights and permissions

Reprints and permissions

About this article

Cite this article

McCormack, P.L., Plosker, G.L. Octocog alfa, Plasma/Albumin-Free Method. Drugs 65, 2613–2620 (2005). https://doi.org/10.2165/00003495-200565180-00005

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00003495-200565180-00005

Keywords

Search

Navigation