Successful Treatment of Patients with von Willebrand Disease using a High-Purity Double-Virus Inactivated Factor VIII/von Willebrand Factor Concentrate (Immunate®)

Abstract

Fourteen patients with different types of von Willebrand disease (vWD) having acute bleeds or elective surgery were treated with Immunate(sound recording copyright sign), a double-virus inactivated factor VIII/von Willebrand factor (FVIII/vWF) concentrate. The concentrate was applied as a bolus or via continuous infusion. FVIII activity (FVIIIc), vWF antigen (vWF:Ag), ristocetin cofactor activity (vWF:RCo), collagen binding activity (vWF:CB), activated partial thromboplastin time (aPTT), and von Willebrand multimers (vW-multimers) were monitored for 48 hours. Pharmacokinetic analyses were performed. The clinical efficacy was rated excellent or good. Bleeding complications occurred in 3 patients due to an additional FXIII deficiency in one patient, to a surgically induced bleed in another patient, and a rather short substitution period in the third patient. There were no serious adverse experiences. One patient showed a phlebitic reaction at the site of venous access after more than 100 hours of continuous infusion, requiring a change to application via bolus.

Pharmacokinetics, Efficacy and Safety of IMMUNATE® Solvent/Detergent (IMMUNATE® S/D) in Previously Treated Patients with Severe Hemophilia A: Results of a Prospective, Multicenter, Open-Label Phase III Study

“…Furthermore, half-life and IR of FVIII determined for IMMUNATE S/D in part 1 and in part 3 of the study were in accordance with published data with other FVIII product studies in PTPs with severe hemophilia A and in a long-term follow-up of prophylactic treatment in patients with severe and moderately severe hemophilia A [20, 21]. The data also demonstrate that IMMUNATE S/D increases VWF levels, which confirms efficacy in von Willebrand disease (VWD) that has been described by Auerswald et al[ 17] for IMMUNATE.…”

“…Considering that a number of these bleeds occurred after a sub-therapeutic dose and occasional prophylactic administration, the results demonstrate that IMMUNATE S/D was efficacious in the prevention of bleeding episodes. Overall, the results obtained in this study are similar to data previously reported in other studies with IMMUNATE, suggesting that IMMUNATE and IMMUNATE S/D are therapeutically equivalent in terms of efficacy [17, 18]. The results of the study demonstrate that secondary prophylaxis, even if started later in life and with increasing joint damage, can reduce the number of bleeding episodes.…”

“…The excellent efficacy and safety profile of Baxter’s FVIII/VWF complex, IMMUNATE, has been demonstrated in controlled clinical studies as well as in clinical practice [17, 18]. IMMUNATE S/D is a next generation, high-purity, freeze-dried, human FVIII concentrate containing VWF and manufactured from pooled human plasma.…”

Pharmacoeconomic analysis of von willebrand factor/blood clotting factor viii concentrate (wilate) in the management of patients with von willebrand disease

“…Blood clotting factor concentrate Immunate was not included in this analysis because the retrieved study results (studies under the supervision of Auerswald G. and Ver Elst K. [10,32] were analyzed) showed the significant difference in cohort composition (patients' distribution by the type of von Willebrand disease) from those in the studies of Haemate P and Wilate. Moreover, the interview of experts from above mentioned centers showed that Immunate is not used in this therapy regimen (however, in the patient information leaflet for Immunate Willebrand disease with factor VIII deficiency is specified as an indication) (tab.…”

Die perioperative Therapie des Von-Willebrand-Syndroms

“…B. nach Bagatelltraumen oder Menorrhagien bei Frauen) auftreten. Bedeutsam bei der Therapie dies Typs 3 ist das Auftreten von Alloantikörpern unter Substitutionstherapie (ähnlich der erworbenen Hemmkörperhämophilie), das die therapeutischen Möglichkeiten erheblich erschweren kann und dessen Häufigkeit in Größenordnungen von 5-15% angegeben wird [1,14,15,18].…”