Deep Vein Thrombosis after Recombinant Factor VIIa Infusion to Control Severe Recurrent Postoperative Bleeding

Pépion, Cédric; Becq, M C; Jacob, Laurent

doi:10.1097/00000542-200604000-00043

Cited by 5 publications

(4 citation statements)

References 11 publications

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“…rFVIIa has been used in various clinical bleeding conditions with some success but potentially leads to thrombotic risks [ [31] , [32] , [33] , [34] , [35] , [36] ]. In this study, we designed the new FVII molecule with a lower coagulant activity aiming to minimize thrombotic complications.…”

Section: Discussionmentioning

confidence: 99%

“…Despite the clinical benefits of rFVIIa, there is evidence showing that rFVIIa is a potent procoagulant agent that potentially leads to an increased risk of thrombotic complications [ [31] , [32] , [33] , [34] , [35] , [36] ], which are the most serious adverse reactions observed in patients with intracerebral hemorrhage [ 25 ], postoperative bleeding [ 33 ], and trauma [ 32 , 34 ] receiving rFVIIa. A study based on the FDA’s Adverse Event Reporting System reported that of the 144 patients who received rFVIIa, 73 thromboembolic events (52%) occurred within 24 hours, and 30 events within 2 hours after the last dose of rFVIIa [ 35 ].…”

Section: Introductionmentioning

confidence: 99%

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Site-directed mutagenesis of tissue factor pathway inhibitor–binding exosite D60A on factor VII results in a new factor VII variant with lower coagulant activity

Seanoon,

Kitiyanant,

Payongsri

et al. 2024

Research and Practice in Thrombosis and Haemostasis

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Site-directed mutagenesis of tissue factor pathway inhibitor–binding exosite D60A on factor VII results in a new factor VII variant with lower coagulant activity

Seanoon,

Kitiyanant,

Payongsri

et al. 2024

Research and Practice in Thrombosis and Haemostasis

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“…Several studies have reported thrombotic complications with eptacog alfa, with the highest thrombosis rates reported when administered for off-label indications; therefore, a theoretical risk for the development of thromboembolic events with eptacog beta exists. 20,21 Patients receiving eptacog beta should be closely monitored for development of thrombosis and intravascular coagulation, given that monitoring FVII levels when giving an rFVIIa product will not be reflective of the hemostatic state. Concomitant use of eptacog beta with other hemostatic agents, such as PCCs, may further increase the risk of eptacog beta–induced thrombosis.…”

Section: Safetymentioning

confidence: 99%

Eptacog Beta for Bleeding Treatment and Prevention in Congenital Hemophilia A and B With Inhibitors: A Review of Clinical Data and Implications for Clinical Practice

et al. 2021

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Objective: To review the pharmacology, dosing and administration, safety, clinical efficacy, and role of eptacog beta in the treatment of congenital hemophilia with inhibitors. Data Sources: A literature search of PubMed (1966 to August 2021) was conducted using the keywords eptacog beta, recombinant FVII, and hemophilia. Study Selection and Data Extraction: All relevant published articles and prescribing information on eptacog beta for the treatment of congenital hemophilia with inhibitors were reviewed. Data Synthesis: Eptacog beta is a novel recombinant activated factor VII (rVIIa) product that demonstrated efficacy in controlling bleeding and associated pain in patients with hemophilia A or B with inhibitors. Eptacog beta has limited Food and Drug Administration–approved and off-label indications compared with other bypassing agents (BPAs; activated prothrombin complex concentrates [aPCC; eptacog alfa]). Eptacog beta costs less than eptacog alfa, but still more than aPCCs. Relevance to Patient Care and Clinical Practice: This review provides insight into the role of eptacog beta for treatment of congenital hemophilia with inhibitors and reviews important health system formulary considerations for available BPAs. Conclusions: Eptacog beta is more cost-effective than eptacog alfa and, as such, may become the preferred rVIIa formulary product. However, eptacog alfa availability remains necessary for the treatment of disorders where eptacog beta has limited data. aPCC should remain the first-line BPA for the treatment of bleeding in patients with inhibitors with no contraindications to use because of its equivocal efficacy and safety and in light of the magnitude of cost savings associated with this strategy.

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“…Due to its mechanism of action, rFVIIa can lead to thrombotic complications such as myocardial and cerebral ischemia, 20 21 deep venous thrombosis or pulmonary thromboembolism. 10 15 22 23 The rate of thromboembolic adverse events (TAEs) related to the use of rFVIIa in hemophiliacs has been 5% to 7% since its introduction. 4 9 24 – 29 This is largely attributed to its action on activated platelets at sites of bleeding only, and the lack of a systemic effect.…”

mentioning

confidence: 99%

Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients

Algahtani

Alshaikh

AlDiab

2010

Annals of Saudi Medicine

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BACKGROUND:There have been recent reports on the successful use of recombinant factor VIIa (rFVIIa) in non-hemophiliac patients who have experienced heavy blood loss due to trauma with extensive organ damage and who have received multiple blood transfusions with hemostatic changes without success. The timing of administration, dosage, mortality, units of blood transfusion saved, risk of thrombotic events, and the risk/benefit ratio are still poorly defined.PATIENTS AND METHODS:We conducted a retrospective review of all medical records of patients who received rFVIIa between January 2003 and March 2008. Data collection included demographic characteristics, diagnosis, indications, comorbidities, and amount of blood products used with rFVIIa, dose of rFVIIa, mortality, and adverse events.RESULTS:We identified 45 patients, 27 (60%) males and 18 (40%) females, with a median age of 52 years. The median dose of rFVIIa was 40 μg/kg (range, 20-120 μg/kg). Five (11.1%) patients needed a second dose of rFVIIa (dose range of 20-85 μg/kg) whereas three patients (6.7%) needed a third dose of rFVIIa (dose range of 40-60 μg/kg). There was a marked and significant reduction in transfusion requirements for packed red blood cells (P=.0078). Overall transfusion requirements significantly decreased after the infusion of rFVIIa (P=.0323). Nineteen patients (42.2%) died and thrombosis was documented in 3 patients (6.7%).CONCLUSION:Use of rFVIIa should be based on sound clinical evidence to balance the risks, benefits, and cost if used among non-hemophiliacs. Prospective randomized studies are needed to investigate the efficacy and cost-effectiveness of rFVIIa for this indication and to allow a final assessment of the importance of this treatment.

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Deep Vein Thrombosis after Recombinant Factor VIIa Infusion to Control Severe Recurrent Postoperative Bleeding

Cited by 5 publications

References 11 publications

Site-directed mutagenesis of tissue factor pathway inhibitor–binding exosite D60A on factor VII results in a new factor VII variant with lower coagulant activity

Site-directed mutagenesis of tissue factor pathway inhibitor–binding exosite D60A on factor VII results in a new factor VII variant with lower coagulant activity

Eptacog Beta for Bleeding Treatment and Prevention in Congenital Hemophilia A and B With Inhibitors: A Review of Clinical Data and Implications for Clinical Practice

Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients

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