Pharmacokinetics and pharmacodynamics of recombinant factor VIIa

Lindley, Celeste; Sawyer, William T.; Macik, B. Gail; Lusher, J.; Harrison, Justin F; Baird-Cox, Kelly; K, Birch; Glazer, Stephen; Roberts, Harold R.

doi:10.1038/clpt.1994.80

Cited by 253 publications

(192 citation statements)

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“…The cause of this difference remains to be elucidated. All three patients showed clearances which were higher than reported both in FVII deficiency (Berrettini et al, 2001) and in other cases (Lindley et al, 1994). These are the result of relatively low volumes of distribution.…”

Section: Patient 1 Patient 2 Patientcontrasting

confidence: 40%

“…Because of its relatively short half-life of c. 3 h both in FVII deficient patients (Berrettini et al, 2001) and in other cases (Lindley et al, 1994), rVIIa has until now not been regarded as a prophylactic treatment option for FVII deficiency, although prophylaxis with rVIIa has been described as an effective therapy in a case report of a boy with haemophilia A and inhibitory antibodies (Saxon et al, 2001). We report treatment of three FVII deficient patients with rVIIa.…”

Section: Discussionmentioning

confidence: 99%

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Prophylactic effect of recombinant factor VIIa in factor VII deficient patients

Mathijssen¹,

Masereeuw

Verbeek³

et al. 2004

Br J Haematol

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Summary Inherited factor VII (FVII) deficiency is a rare autosomal recessive disorder associated with a bleeding tendency. We describe three patients with congenital FVII deficiency who have been treated with activated recombinant factor VII (rVIIa). Two patients had novel mutations and were treated prophylactically with 1·2 mg rVIIa two to three times a week. Patients 1 and 2 had a severe bleeding tendency. The frequency and severity of bleeding decreased by treatment with rVIIa compared with similar treatment with plasma‐derived FVII. The third patient with a moderate bleeding phenotype was treated on demand and showed no change in the frequency of bleeding upon treatment with rVIIa or plasma products. The beneficial effect of rVIIa cannot be explained by the rVIIa half‐lives. Pharmacokinetical analysis showed rVIIa activity half‐lives of 35, 50 and 54 min for patients 1, 2 and 3, respectively. In conclusion, prophylactic treatment of FVII deficient patients with rVIIa appears to be applicable, safe and successful, although the mechanism of action remains to be elucidated.

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Section: Patient 1 Patient 2 Patientcontrasting

confidence: 40%

Section: Discussionmentioning

confidence: 99%

Prophylactic effect of recombinant factor VIIa in factor VII deficient patients

Mathijssen¹,

Masereeuw

Verbeek³

et al. 2004

Br J Haematol

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“…Pharmacokinetic properties of rFVIIa are predictable and well characterized. Half-life of rFVIIa is 2.7 h [2].…”

Section: Recombinant Factor Viia: Mechanism Of Actionmentioning

confidence: 99%

Rational Use of Recombinant Factor VIIa in Clinical Practice

Dutta

Verma

2013

Indian J Hematol Blood Transfus

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In the United States, the FDA-approved indications for recombinant factor VIIa is for bypassing inhibitors to factors VIII and IX in patients with hemophilia A and B respectively and for treatment of congenital factor VII deficiency. In European countries, rFVIIa is licensed for the above indications as well as for Glanzmann's thrombasthenia. In absence of high-quality data favoring off-label use of this agent and laboratory test to predict response to this agent, and in view of high cost of rFVIIa, off-label use of recombinant factor VIIa should be restricted to only when hemorrhage has not responded to transfusion or other conventional therapy. It appears, two such conditions where recombinant factor VIIa may be beneficial are traumatic and postpartum hemorrhages.

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“…37 The half-life is 2.3 hours in adults but potentially shorter in children. 38 Attempts to protein engineer rfVIIa to have a longer circulation time are currently underway. 39,40 FEIBA VH is a vapor-heated concentrate of plasma-derived vitamin K-dependent clotting factors (factors II, VII, IX, and X and others) in both zymogen and active forms.…”

Section: Treatment Of Acute Bleedingmentioning

confidence: 99%

How we treat a hemophilia A patient with a factor VIII inhibitor

Kempton

White

2009

Blood

152

144

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The most significant complication of treatment in patients with hemophilia A is the development of alloantibodies that inhibit factor VIII activity. In the presence of inhibitory antibodies, replacement of the missing clotting factor by infusion of factor VIII becomes less effective. Once replacement therapy is ineffective, acute management of bleeding requires agents that bypass factor VIII activity. Long-term management consists of eradicating the inhibitor through immune tolerance. Despite success in the treatment of acute bleeding and inhibitor eradication, there remains an inability to predict or prevent inhibitor formation. Ideally, prediction and ultimately prevention will come with an improved understanding of how patientspecific and treatment-related factors work together to influence anti-factor VIII antibody production. (Blood. 2009;113: 11-17)

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Pharmacokinetics and pharmacodynamics of recombinant factor VIIa

Abstract: The pharmacokinetics of rFVIIa are linear in the dose range evaluated. The results suggest potential value of prothrombin time determination in the monitoring of rFVIIa therapy.

Cited by 253 publications

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Prophylactic effect of recombinant factor VIIa in factor VII deficient patients

Prophylactic effect of recombinant factor VIIa in factor VII deficient patients

Rational Use of Recombinant Factor VIIa in Clinical Practice

How we treat a hemophilia A patient with a factor VIII inhibitor

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