The Continuous Infusion of Recombinant Activated Factor VIIa (rFVIIa) in Patients with Factor VIII Inhibitors Activates the Coagulation and Fibrinolytic Systems without Clinical Complications

Baudo, F.; Redaelli, R; Caimi, Teresa Maria; Mostarda, G; Somaini, Gabriella; Cataldo, F

doi:10.1016/s0049-3848(00)00220-6

Cited by 28 publications

(19 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It is unclear, however, whether laboratory markers of activated coagulation are predictive of subsequent thrombotic events. Baudo and colleagues have recently reported a lack of clinical complications during treatment with rFVIIa despite laboratory evidence of DIC [25]. Roberts' review of the safety of rFVIIa in 1998 cited two cases of angina in elderly people following rFVIIa administration.…”

Section: Discussionmentioning

confidence: 99%

A new approach to treatment of bleeding episodes in young hemophilia patients: a single bolus megadose of recombinant activated factor VII (NovoSeven®)

Kenet¹,

Lubetsky²,

Luboshitz³

et al. 2003

Journal of Thrombosis and Haemostasis

126

119

View full text Add to dashboard Cite

Summary. Recombinant activated factor VII (rFVIIa, NovoSeven 1 ) represents an effective treatment for hemophilia patients with inhibitors, but no consensus as to the best dosing regimen exists. We assessed the efficacy and safety of a rFVIIa 'megadose' (300 mg kg À1 bolus) as treatment for bleeds in three young inhibitor patients. Of 114 bleeds, 95 responded to a single dose. Pain relief was faster and therapy duration significantly shorter than with continuous infusion (CI) regimens or standard boluses (90 mg kg À1 every 3 h). Rebleeding occurred in 9.6% of cases and 19/114 episodes required a second bolus injection. Although rFVIIa consumption per bleed (median: 300 mg kg À1 ) was higher than with standard boluses (180-270 mg kg À1 ), patients found single bolus administration more convenient than recurrent injections or CI. With two exceptions, no complications occurred within 3 h of treatment, despite high FVII:C levels (median: 27.4 U mL À1 ; range: 19.8-54 U mL À1 ). Treatment of bleeds with a rFVIIa megadose in young inhibitor patients is effective and well tolerated.

show abstract

Section: Discussionmentioning

confidence: 99%

A new approach to treatment of bleeding episodes in young hemophilia patients: a single bolus megadose of recombinant activated factor VII (NovoSeven®)

Kenet¹,

Lubetsky²,

Luboshitz³

et al. 2003

Journal of Thrombosis and Haemostasis

126

119

View full text Add to dashboard Cite

show abstract

“…The difference in response was due to the types and aggressiveness of surgery, complications after surgery such as infection, the adjuvant of other hemostatic agents such as tranexamic acid and the dose of rFVIIa used during treatment (Table 1). 37–44,46,48–50…”

Section: Independent Published Reportsmentioning

confidence: 99%

Critical appraisal of the role of recombinant activated factor VII in the treatment of hemophilia patients with inhibitors

Chuansumrit¹

2010

JBM

View full text Add to dashboard Cite

Hemophilia patients with inhibitors faced the constraint of inadequate treatment for several years before the era of recombinant factor VIIa (rFVII). Initially, rFVIIa was used in the compassionate-use programs. After a worldwide license was issued, more than 1.5 million doses were administered. Bleeding of joints and muscles was controlled effectively by means of an early home treatment program, with either a standard dose of 90 μg/kg every 2 to 3 hours for a few doses or a single dose of 270 μg/kg. For more serious bleeding episodes or minor surgery, an initial dose of 90 μg/kg was given every 2 hours for 24 to 48 hours followed by increased intervals of 3 to 6 hours according to the severity of bleeding and efficacy of bleeding control. In cases of major surgery such as orthopedic procedures, the same regimen can be applied except for a higher initial dose of 120 to 180 μg/kg. However, increasing the dose should be considered if there are unexpected bleeding complications since the half-life and clearance of rFVIIa differ between individuals. In addition, prophylaxis is administered to a small number of patients. Finally, the reported thromboembolic events found in hemophilia patients with inhibitors receiving rFVIIa are extremely low, much less than 1%.

show abstract

“…Some hematologists have given rFVIIa by continuous infusion, but this mode of administration must be considered experimental. 28 As for aPCCs, no laboratory marker has been established to guide therapy. Some clinicians follow plasma factor VII activity, which rises to supra-physiological levels during treatment, 24 but the validity of using this as a surrogate marker for the clinical response has not been rigorously validated.…”

Section: Acquired Hemophiliamentioning

confidence: 99%

Unexpected Bleeding Disorders

Aledort

Teitel

2001

Hematology

View full text Add to dashboard Cite

Patients with known coagulation deficiencies, either congenital or acquired, may bleed spontaneously with trauma or with surgical intervention. In contrast, however, are the unchallenged patients who bleed in a variety of clinical settings that demand rapid diagnosis so that appropriate therapy can be instituted.In the first section Dr. Louis M. Aledort demonstrates a series of vignettes of actual cases who presented with unexpected bleeding or a screening laboratory abnormality prior to a needed surgical intervention. Settings include dental, oral surgical, obstetrical, surgical and gynecological. The differential diagnoses of these cases are discussed.In the second section Dr. David Green also uses vignettes to demonstrate how the laboratory is used to differentiate the various clinical entities. The choice and priority of required tests indicated by the settings, history, site and type of bleeding, and the syllogisms used to define the abnormality are stressed.In the third section, Dr. Jerome Teitel reviews in detail the therapeutic armamentarium available to the clinician and presents algorithms for the management of these bleeding disorders.

show abstract

The Continuous Infusion of Recombinant Activated Factor VIIa (rFVIIa) in Patients with Factor VIII Inhibitors Activates the Coagulation and Fibrinolytic Systems without Clinical Complications

Cited by 28 publications

References 7 publications

A new approach to treatment of bleeding episodes in young hemophilia patients: a single bolus megadose of recombinant activated factor VII (NovoSeven®)

A new approach to treatment of bleeding episodes in young hemophilia patients: a single bolus megadose of recombinant activated factor VII (NovoSeven®)

Critical appraisal of the role of recombinant activated factor VII in the treatment of hemophilia patients with inhibitors

Unexpected Bleeding Disorders

Contact Info

Product

Resources

About