Antihemophilic Agent; Blood Product Derivative

Treatment of bleeding episodes in patients with hemophilia A or B when inhibitors to Factor VIII or Factor IX are present

C

Known hypersensitivity to Factor VII or any component of the product, or known hypersensitivity to mouse, hamster, or bovine proteins

Patients should be monitored for signs and symptoms of activation of the coagulation system or thrombosis. Thrombotic events may be increased in patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, sepsis or crush injury. Decreased dosage or discontinuation is warranted in confirmed DIC. Efficacy with prolonged infusions and data evaluating this agent's long-term adverse effects are limited.

1% to 10%:

Cardiovascular: Hypertension

Hematologic: Hemorrhage, decreased plasma fibrinogen

Musculoskeletal: Hemarthrosis

<1%: Allergic reactions, pruritus, purpura, rash, injection-site reactions, vomiting, headache, hypotension, bradycardia, edema, arthrosis, coagulation disorder, increased fibrinolysis, disseminate intravascular coagulation (DIC), decreased prothrombin, pneumonia, abnormal renal function.

Experience with overdose in humans is limited; an increased risk of thrombotic events may occur in overdosage; treatment is symptomatic and supportive

Store under refrigeration (2°C to 8°C/36°F to 46°F); reconstituted solutions may be stored at room temperature or under refrigeration, but must be infused within 3 hours of reconstitution

Recombinant Factor VIIa, a vitamin K-dependent glycoprotein, promotes hemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation Factor VII, which complexes with tissue factor and may activate coagulation Factor X to Xa and Factor IX to IXa. When complexed with other factors, coagulation Factor Xa converts prothrombin to thrombin, a key step in the formation of a fibrin-platelet hemostatic plug

Distribution: V_d: 103 mL/kg (78-139)

Half-life: 2.3 hours (1.7-2.7)

Clearance: 33 mL/kg/hour (27-49)

Children and Adults: I.V. administration only: 90 mcg/kg every 2 hours until hemostasis is achieved or until the treatment is judged ineffective. The dose and interval may be adjusted based upon the severity of bleeding and the degree of hemostasis achieved. The duration of therapy following hemostasis has not been fully established; for patients experiencing severe bleeds, dosing should be continued at 3-6 hour intervals after hemostasis has been achieved and the duration of dosing should be minimized.

I.V. administration only; reconstitute only with the specified volume of sterile water for injection, USP; administer within 3 hours after reconstitution

Monitor for evidence of hemostasis; although the prothrombin time, aPTT, and factor VII clotting activity have no correlation with achieving hemostasis, these parameters may be useful as adjunct tests to evaluate efficacy and guide dose or interval adjustments

No information available to require special precautions

No effects or complications reported

Powder for injection: 1.2 mg, 2.4 mg, 4.8 mg