Activated recombinant human coagulation factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII

Liebman, Howard A.; Chediak, Juan; Fink, Kenneth; Galvez, Angel G.; Shah, Prabodh; Sham, Ronald L.

doi:10.1002/(sici)1096-8652(200003)63:3<109::aid-ajh1>3.0.co;2-o

Cited by 38 publications

(20 citation statements)

References 17 publications

(31 reference statements)

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“…The dose of 90 lg/kg in our study was selected on the basis of the experience gained in rFVIIa trials in hemophiliacs [13,14]. It has also been demonstrated that this dosage results in signi®cant reduction of the bleeding time in patients with thrombocytopenia [9].…”

Section: Discussionmentioning

confidence: 99%

Effective hemostasis with rFVIIa treatment in two patients with severe thrombocytopenia and life‐threatening hemorrhage

et al. 2002

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We report two patients with severe thrombocytopenia and life-threatening bleeding that were successfully managed with recombinant activated factor VII (rFVIIa). The ®rst was a 75-year-old male with Waldenstro È mÕs macroglobulinemia. During a therapeutic course with¯udarabine, he developed severe autoimmune thrombocytopenia resistant to conventional treatment, followed by persistent uncontrollable nasal bleeding. Platelet transfusions failed to increase the platelet count and control the hemorrhage. When hemoglobin levels fell below 8.5 g/dL and the patientÕs clinical condition got much worse, a single dose of 4.8 mg rFVIIa (90 lg/kg) was given as an i.v. bolus. Ten minutes after the rFVIIa injection, nasal bleeding stopped, the patientÕs clinical condition progressively improved, and splenectomy could be carried out uneventfully 2 days later. The second patient, a 52-year-old female, was under treatment for pre-B lymphoblastic leukemia. She developed severe thrombocytopenia, secondary to chemotherapy, complicated by massive gastrointestinal bleeding. Despite intensive treatment with platelet transfusions, hemorrhage continued and her condition deteriorated rapidly. She was then given an i.v. bolus injection of 4.8 mg rFVIIa, which resulted in cessation of hemorrhage and dramatic improvement of her clinical status. No adverse effects from the treatment with rFVIIa were observed. In conclusion, rFVIIa appears to be an attractive alternative for controlling hemorrhage in patients with severe thrombocytopenia, especially when platelet transfusions are unavailable or ineffective. Am.

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Section: Discussionmentioning

confidence: 99%

Effective hemostasis with rFVIIa treatment in two patients with severe thrombocytopenia and life‐threatening hemorrhage

et al. 2002

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“…As a result, in many cases, the interval between the start of bleeding and the start of treatment with rFVIIa was relatively long as other therapies had already been tried without success [63]. Results from this study have been reported in several papers, and it is not clear to what extent the data reported in some of those papers [54,63–66] overlap.…”

Section: Efficacy Of Rfviia In the Treatment Of Severe Bleedingmentioning

confidence: 96%

Control of bleeding in patients with haemophilia A with inhibitors: a systematic review

et al. 2003

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This paper reports a systematic review of the best available evidence of clinical effectiveness in the treatment of acute bleeding in haemophilia A patients with inhibitors. Because of the lack of randomized controlled trials (RCTs) on this topic, broad inclusion criteria with regard to study design were applied in order to assess the best available evidence for each intervention. Because of the clinical and methodological heterogeneity of the evidence, it was not appropriate to pool data across studies; instead, data were synthesized using tabulation and qualitative narrative assessment. No evidence was found to support the use of high-dose factor VIII (FVIII) in bleeding episodes. However in surgery it was found to be highly successful (100%) for low-titre, low-responding inhibitors although not reliable for high-responding inhibitors. Porcine FVIII (pFVIII) was effective in the control of severe bleeding episodes with high-titre or high-responding inhibitors (100%) and in 60-90% of surgical procedures. Activated prothrombin complex concentrates (APCCs) appear to be more effective than prothrombin complex concentrates (PCCs) in the control of mild to severe bleeding episodes. There was no good evidence for the use of PCCs in surgery. APCCs controlled bleeding in approximately 90% of surgical episodes. Recombinant factor VIIa (rFVIIa) controlled 70-100% of mild to severe bleeding episodes with high-responding inhibitors, and achieved better results when used early. It was effective in 60-100% of surgical episodes. Doses varied from study to study, and side-effects from mild to infrequent but serious adverse events were reported. The quality of the evidence is variable. Limited evidence relating to other treatment options is also included in the review.

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“…16 Two later systematic reviews confirmed these findings, reporting an efficacy rate of 70 to 100% when rFVIIa was used to control acute (including severe) bleeds in hemophilia patients with inhibitors. 17,18 Evidence accumulated from compassionate-and emergency-use programs also suggests that rFVIIa is effective in 69 to 91% of serious and life-or limb-threatening hemorrhages in this patient population [19][20][21][22] (of 79 patients in three of these studies, 21 had acquired hemophilia, 5 had FVII deficiency, and 2 had ''other'' coagulopathies [19][20][21]. A more recent systematic review concluded that overall efficacy and bleed cessation rates are higher for rFVIIa than for pd-aPCC (FEIBA; Baxter, Deerfield, IL) (81 to 91% and 64 to 80%, respectively) when standard dosage regimens are used to treat mild to moderate bleeds in inhibitor patients.…”

Section: Clinical Experience With Rfviia In Hemophilia With Inhibitorsmentioning

confidence: 99%

Recombinant Activated Factor VII: Mechanisms of Action and Current Indications

Franchini

Lippi

2010

Semin Thromb Hemost

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Recombinant activated factor VII (rFVIIa) was initially developed to overcome the limitations of existing treatments for patients with congenital hemophilia and inhibitors. Clinical success in this arena led to experimental use in other coagulopathies characterized by impaired thrombin generation, and approval for use in acquired hemophilia, factor VII deficiency, and Glanzmann's thrombasthenia soon followed. Extensive research and growing experience in the clinical setting has increased our knowledge of rFVIIa and improved our understanding of how its mechanism of action leads to effective bleeding control. This article reviews current understanding of the mechanisms of action of rFVIIa before providing a brief overview of clinical experience to date in its licensed indications. The agent's safety profile is also examined, along with recent advances in rFVIIa dosing and storage that may help to improve both clinical outcomes and patient quality of life.

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Activated recombinant human coagulation factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII

Cited by 38 publications

References 17 publications

Effective hemostasis with rFVIIa treatment in two patients with severe thrombocytopenia and life‐threatening hemorrhage

Effective hemostasis with rFVIIa treatment in two patients with severe thrombocytopenia and life‐threatening hemorrhage

Control of bleeding in patients with haemophilia A with inhibitors: a systematic review

Recombinant Activated Factor VII: Mechanisms of Action and Current Indications

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