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References

  1. ADVATE Prescribing Information.
  2. Valentino LA, Mamonov V, Hellmann A, et al. A randomized comparison of two prophylaxis regimens and a paired comparison of on–demand and prophylaxis treatments in hemophilia A management [published correction appears in J Thromb Haemost. 2012;10(6):1204]. J Thromb Haemost. 2012;10(3):359–367.
  3. Shapiro AD, Schoenig-Diesing C, Silvati-Fidell L, Wong WY, Romanov V. Integrated analysis of safety data from 12 clinical interventional studies of plasmaand albumin-free recombinant factor VIII (rAHF-PFM) in haemophilia A. Haemophilia. 2015;21(6):791–798.
  4. Tarantino MD, Collins PW, Hay CR, et al, and the RAHF–PFM Clinical Study Group. 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;10(5):428–437.
  5. Négrier C, Shapiro A, Berntorp E, et al. Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin–free method: efficacy and safety of ADVATE in previously treated patients. Thromb Haemost. 2008;100(2):217–223.
  6. Blanchette VS, Shapiro AD, Liesner RJ, et al, for the rAHF–PFM Clinical Study Group. Plasma and albumin–free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients. J Thromb Haemost. 2008;6(8):1319–1326.
  7. Auerswald G, Thompson AA, Recht M, et al. Experience of Advate rAHF–PFM in previously untreated patients and minimally treated patients with haemophilia A. Thromb Haemost. 2012;107(6):1072–1082.
  8. Grillberger L, Kreil TR, Nasr S, Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J. 2009;4(2):186–201.
  9. Data on file; Shire US Inc.
  10. Maruish ME, ed. User’s Manual for the SF–36v2 Health Survey. 3rd ed. Lincoln, RI: QualityMetric Incorporated; 2011.
  11. National Hemophilia Foundation. MASAC recommendation #243 on SIPPET (Survey of Inhibitors in Plasma-Product-Exposed Toddlers): results and recommendations for treatment products for previously untreated patients with hemophilia A. https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations/MASAC-Recommendation-On-SIPPET-Survey-of-Inhibitors-in-Plasma-Product-Exposed-Toddlers. Published June 2016. Accessed March 22, 2017.