Beriplex® P/N Provides Fast, Predictable and Safe Anti-coagulation Reversal, According to Study
Data presented at ISTH XXIst Congress show Beriplex P/N is 98 percent effective in emergency bleeding situations
Geneva, Switzerland — 10 July 2007
Beriplex® P/N, a human prothrombin complex concentrate (PCC), is highly effective and safe in the emergency reversal of anti-coagulation, according to data presented today at the International Society on Thrombosis and Haemostasis (ISTH) XXIst Congress. The data showed Beriplex P/N rapidly and safely increases plasma levels of essential coagulation factors II, VII, IX, and X and anticoagulant inhibitors Protein C and Protein S prior to emergency interventions or to treat acute bleeding.
Anti-coagulation reversal (ACR) is used to correct the effects of oral anticoagulants (such as warfarin) taken by patients to prevent and treat thromboembolic disease. It may be required in preparation for elective or emergency surgery or during an acute bleeding episode. Therapeutic options currently available for ACR include Vitamin K for non-emergency situations and human plasma, or PCCs, which are appropriate for urgent correction of anticoagulation effects.
“The number of patients receiving long-term anticoagulant therapy is growing, as is the need to quickly reverse the effects of these medications in certain circumstances,” said Dr. Ingrid Pabinger-Fasching, Department of Internal Medicine I, Division of Hematology and Hemostaseology, University Hospital Vienna, principal investigator of the study. “While multiple options for anti-coagulation reversal exist when time is not an issue, our data show that Beriplex P/N offers fast, complete, predictable and safe reversal of the anticoagulation effect when urgency is required.”
Today’s Presentation: Study Design
Findings were based on a multi-national study that took place at 25 centres in eight countries. Enrolled in the prospective, open, uncontrolled study were 43 patients aged 22 – 85 years (34 patients age >65 years, 79%) who required emergency ACR due to either emergency intervention, such as vascular or abdominal surgery (26 patients, 60%) or acute bleeds (17 patients, 40%). Almost all patients had multiple risk factors for developing a thromboembolic event. With regard to dosing and infusion of Beriplex P/N, median administration speed was 188 IU/min (range 50-1000), and median infusion time was 12 minutes (range 3-50). Most patients simultaneously received IV Vitamin K.
The primary endpoint of 30-minute post-infusion International Normalized Ratio (INR) ≤ 1.3 was met. Factor recovery was >1 for all coagulation factors administered with Beriplex P/N (Factor II, VII, IX and X and thrombo-inhibitors Protein C and Protein S). Ninety-eight percent of patients (42 patients) were assessed as having “very good” or “satisfactory” response to therapy. The rapid reversal of anticoagulation provided accelerated and effective control of hemorrhage. Further, all administrations were well tolerated, and no virus transmission (HAV, HBV, HCV, HIV or Parvo B19) was observed. Of six reported serious adverse events, five have been confirmed to be unrelated to Beriplex P/N use; one event was reported possibly related.
Phase I PK Study Confirms Rapid Control
In a separate Phase I pharmacokinetics study presented at the ISTH XXIst Congress, Dr. Helmut Ostermann of University Hospital Munich and colleagues found that Beriplex administered to 15 healthy volunteers induced a rapid increase in plasma concentrations of coagulation factors II, VII, IX and X, as well as anticoagulant proteins C and S. Maximum levels were reached within 5 minutes after infusion.
"These findings, together with the fact that Beriplex has a more rapid preparation and administration time than other PCCs, indicate that Beriplex is an excellent choice for patients requiring a rapid response time," said Dr. Ostermann.
About Anti-coagulation Reversal (ACR)
Anti-coagulant reversal (ACR) is used to correct the effects of oral anticoagulants taken by patients to prevent and treat thromboembolic disease. It can be administered over time with various methods when urgency is not required, such as when preparing for elective surgery. However, emergency ACR may be required due to the need for urgent surgery or because a patient experiences an acute bleed.
About Beriplex® P/N
Beriplex P/N is a plasma-derived prothrombin complex concentrate (PCC) containing a number of important coagulation factors and anti-thrombotic factors. Beriplex P/N may be used to urgently stop bleeding in patients on oral anti-coagulants, urgently correct coagulation before major surgery, and normalize coagulation in patients with liver disease where the respective essential coagulation factors normally produced by the liver are missing or insufficient. Beriplex P/N can be stored at room temperature and does not require warming before administration. It reconstitutes quickly and has an infusion speed of 8 ml/min. Beriplex P/N has been used in some countries for more than 20 years and its safety and efficacy have been evaluated in three prospective clinical trials.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about saving and improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of rare diseases such as immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
Sheila A. Burke
Director, Communications & Public Relations
Worldwide Commercial Operations, CSL Behring
MCS Public Relations