Economic analysis of recombinant activated factor VII versus plasma-derived activated prothrombin complex concentrate in mild to moderate bleeds: Haemophilia registry data from the Czech Republic

2012 ◽  
Vol 129 (5) ◽  
pp. e233-e237 ◽  
Author(s):  
Peter Salaj ◽  
Miroslav Penka ◽  
Petr Smejkal ◽  
Vera Geierova ◽  
Petra Ovesná ◽  
...  
Keyword(s):  
Czech Republic ◽  
Economic Analysis ◽  
Prothrombin Complex Concentrate ◽  
Registry Data ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
The Czech Republic ◽  
Activated Factor Vii ◽  
Activated Prothrombin Complex Concentrate

scholarly journals Therapeutic challenges in acquired factor VIII deficiency

Hematology ◽  
2012 ◽  
Vol 2012 (1) ◽  
pp. 369-374 ◽  
Author(s):  
Peter W. Collins
Keyword(s):  
Prothrombin Complex Concentrate ◽  
Current Data ◽  
Factor Vii ◽  
Close Collaboration ◽  
First Line ◽  
Acquired Hemophilia ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Activated Prothrombin Complex Concentrate ◽  
Prompt Diagnosis

Abstract Management of acquired hemophilia A is challenging and should be undertaken in close collaboration with a hemophilia center with expertise in the field. Treatment involves controlling and preventing bleeds and using immunosuppression to eradicate the inhibitor. Prompt diagnosis is important to allow early hemostatic treatment and to prevent nonessential invasive procedures. First-line hemostatic treatment should be with a bypassing agent. Recombinant activated factor VII and the activated prothrombin complex concentrate anti-inhibitor coagulant complex (Factor Eight Inhibitor Bypassing Activity, or FEIBA) but equally efficacious but both associated with thrombotic events when used in acquired hemophilia. Immunosuppression should be started as soon as a diagnosis has been confirmed. The combination of steroids and cyclophosphamide may induce more patients into remission than steroids alone. Current data do not suggest that rituximab results in better outcomes. Relapse is common (10%-20%) in the first 6 months after immunosuppression is stopped, and patients need to be followed up regularly to allow early diagnosis and treatment of relapse.

Potential of Activated Prothrombin Complex Concentrate and Activated Factor VII to Reverse the Anticoagulant Effects of Rivaroxaban in Primates

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3825-3825 ◽  
Author(s):  
András Gruber ◽  
Ulla M Marzec ◽  
Ulf Buetehorn ◽  
Stephen Hanson ◽  
Elisabeth Perzborn
Keyword(s):  
Prothrombin Time ◽  
Prothrombin Complex Concentrate ◽  
Bleeding Time ◽  
Fold Increase ◽  
Fold Change ◽  
Factor Vii ◽  
High Dose ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Activated Prothrombin Complex Concentrate

Abstract Rivaroxaban is an oral, direct Factor Xa (FXa) inhibitor that has been recommended for approval by the Committee for Medicinal Products for Human Use for the prevention of venous thromboembolism after elective hip and knee replacement, and is in advanced clinical development for the prevention and treatment of thromboembolic disorders. Because bleeding is a potential side-effect of accidental rivaroxaban overdose, we evaluated whether activated prothrombin complex concentrate (APCC, FEIBA®) and recombinant activated Factor VII (rFVIIa, NovoSeven®) administration could mitigate the antihemostatic effects of high-dose rivaroxaban in juvenile male baboons. Pharmacologic impairment of hemostasis (3- to 4-fold increase in prothrombin time [PT] from baseline and ≥2-fold increase in template bleeding time [BT]) was achieved by an intravenous (i.v.) bolus of rivaroxaban (0.6 mg/kg) followed by continuous infusion (0.6 mg/kg/h) for 60 minutes. At steady-state anticoagulation (30 minutes from bolus), one group of anticoagulated baboons (n=7) received APCC (50 U/kg, over 25 minutes). A second group (n=7) received an i.v. bolus dose of rFVIIa (210 μg/kg) 30 minutes after the start of anticoagulation. Reversal of the antihemostatic effects of supratherapeutic doses of rivaroxaban by APCC and rFVIIa was assessed by measurement of BT and clotting times. In the APCC group, high-dose rivaroxaban prolonged BT to 202% (95% CI±21%; p<0.001) of baseline and PT by 3-fold (Table). On completion of APCC infusion, BT returned to baseline and PT was reduced. In the rFVIIa group, rivaroxaban prolonged BT to 254% (95% CI±30%; p<0.05). Infusion of rFVIIa reduced BT by 34%, and PT was also shortened. Circulating thrombin–antithrombin complex (TAT) levels decreased during rivaroxaban infusion, and this decrease did not change significantly after rFVIIa bolus administration. However, APCC increased baseline plasma TAT levels, suggesting a systemic hypercoagulation. We conclude that administration of APCC or rVIIa can rapidly attenuate hemostasis impairment after rivaroxaban overdose in baboons, thus providing potential antidotes during bleeding emergencies. Table. The effect of activated prothrombin complex concentrate (APCC) and recombinant activated Factor VII (rFVIIa) on bleeding time (BT), prothrombin time (PT), and thrombin–antithrombin complex concentration (TAT) in baboons anticoagulated with high-dose rivaroxaban (n=7 each). Values are given as mean ± standard deviation Time BT (x-fold change from baseline) PT (x-fold change from baseline) TAT (μg/L) APCC Baseline 1.00 1.00 3.51±0.08 30 minutes after rivaroxaban 2.02±0.56 3.04±0.43 3.01±1.37 At end of APCC infusion 1.02±0.33 2.20±0.29 10.35±1.41 20 minutes after end of APCC infusion 1.65±0.94 2.28±0.29 n.d. rFVIIa Baseline 1.00 1.00 7.35±4.17 30 minutes after rivaroxaban 2.54±0.79 3.17±0.42 2.95±0.79 5 minutes after rFVIIa 1.68±0.80 2.38±0.41 2.58±0.52 30 minutes after rFVIIa 1.96±1.26 2.48±0.49 4.00±1.12

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