For Healthcare ProfessionalsIntended for US Audiences
ADVATE Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; May 2015.
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.
Data on file. Westlake Village, CA; Baxalta Healthcare Corporation.
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.
Shapiro A, Gruppo R, Pabinger I, et al. Integrated analysis of safety and efficacy of a plasma– and albumin–free recombinant factor VIII (rAHF–PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009;9(3):273–283.
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.
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.
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.
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.
Oldenburg J, Goudemand J, Valentino L, et al. Post authorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin–free method] demonstrates efficacy, safety and low–risk for immunogenicity in routine clinical practice. Haemophilia. 2010;16(6):866–877.
PROLabels: patient–reported outcomes & drug marketing authorizations. PROLabels Web site. http://www.mapi–prolabels.org. Accessed November 17, 2014.
Maruish ME, ed. User’s Manual for the SF–36v2 Health Survey. 3rd ed. Lincoln, RI: QualityMetric Incorporated; 2011.
White GC, DiMichele D, Mertens K, et al. Utilization of previously treated patients (PTPs), noninfected patients (NIPs), and previously untreated patients (PUPs) in the evaluation of new factor VIII and factor IX concentrates. Recommendation of the Scientific Subcommittee on Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost. 1999;81(3):462.