Patients with factor VIII or IX inhibitor

• Vigorous bleeding, impending compartment syndrome, or bleeding in critical location: 90 μg/kg q 2–3 hours until patient hemostasis is achieved, then less frequently thereafter.

• Persistent bleeding, not life or limb threatening: titrate both dose and interval to obtain adequate hemostasis.

• Prior to invasive procedures: 90 μg/kg initially, subsequent doses, interval, and duration of treatment titrated to bleeding risk.

• No signs of bleeding, stable Hgb: rFVIIa not indicated.

Qualitative, quantitative platelet disorders and life threatening bleeding unresponsive to platelet transfusion.

• Correct coagulopathy and anemia with platelets, FFP, cryoprecipitate, and red cell transfusions.

• Administer DDAVP and Amicar.

• Dialyze if uremic.

• rFVIIa 4.8 mg vial (50–100 μg/kg for 100–50 kg patient). If clinical response, titrate dose and interval to maintain adequate hemostasis.

Prolonged INR requiring rapid reversal

• Minimal or no active bleeding

  • 10 mg Vitamin K IV or SQ

• Life or limb at risk

  • 1.2 mg vial rFVIIa**, and

  • FFP 15–20 mL/kg, and

  • 10 mg vitamin K, IV infused over 20 minutes

  • *20 μg/kg for a 70 kg patient; subsequent doses of rFVIIa indicated for clinical signs of persistent bleeding, not to maintain a normal PT/INR.

Uncontrollable hemorrhage associated with trauma, surgery, and liver failure.

• Replace consumed/diluted hemostatic factors with FFP, cryoprecipitate, platelet transfusion, red cell transfusions.

• Periodically monitor PT, aPTT, fibrinogen, platelet count, hemoglobin.

• If excessive bleeding continues without apparent response to adequate blood components and no identifiable surgical source has been found, 4.8 mg vial rFVIIa (50–100 μg/kg for 100–50 kg patient). If bleeding does not diminish in 30–60 minutes, consider one more dose or surgical exploration.

• Use rFVIIa with caution in patients at increased risk for thrombotic complications:

  • After cardiac surgery

  • Patients with history of coronary artery disease

  • Patients with history of venous or arterial thrombosis

  • Patients with DIC

  • Patients on ECMO or VAD

  • Patients with cerebral vascular disease

Congenital factor VII deficiency.

• Factor VII activity > 25%, expectant management except neurologic, cardiothoracic, or ophthalmologic surgery/trauma.

• Factor VII activity < 25% and minor trauma/surgery:

  • Initial treatment: 10–15 mL/kg FFP

  • Repeat 3–6 mL/kg at 6–8 hour intervals until hemostasis is achieved.

• Factor VII activity < 25% and at risk for neuro, cardiothoracic, ophthalmologic bleeding:

  • Initial treatment: rFVIIa 1.2 mg vial (20 μg/kg for 70 kg patient) q 2 hours until hemostasis is achieved.

  • Titrate dose and interval to ongoing bleeding risk.

  • Combined treatment with FFP and rFVIIa at lower doses is a consideration, in patients who can tolerate volume infusions.