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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Slide: 6 of 36

Off-Label Uses of rFVIIa

The use of rFVIIa for off-label clinical indications originates in the ability of rFVIIa to “bypass” multiple defects in the coagulation pathway. These uses are listed by their relative proximity to the FDA approved uses. The following categories suggest increasing extension of rFVIIa use into clinical areas with diminishing similarity to the FDA approved uses.

1. Chronic prophylactic use in hemophilia A and B in the absence of bleeding episodes or procedures. While not approved by the FDA, this form of use has been approved in Australia. 2. Episodic use in other congenital and acquired clotting factor defects, including hemophilia C, von Willebrand’s disease, and factor VII deficiency, as well as in other rare coagulopathies. 3. Episodic use for isolated congenital or acquired clotting defects that arise from deficiency or dysfunction of other components of the coagulation process. This includes platelet dysfunction, such as Glanzmann’s thrombasthenia, which has been approved by the EMEA but not the FDA. 4. Episodic use in disease states where impaired coagulation is but one manifestation. Liver disease is a prominent example, but other conditions include leukemia, lymphoma, and other cancers. 5. Episodic use where anticoagulant therapy contributes to bleeding problems beyond what would exist otherwise. This includes patients on warfarin and those undergoing cardiac surgery with cardiopulmonary bypass that requires heparin anticoagulation. 6. Clinical circumstances where a consumptive coagulopathy has developed as the result of substantial and rapid blood loss. In practice, this often includes trauma patients and those with massive gastrointestinal bleeding. 7. Situations where significant blood loss is anticipated in the absence of pre-existing coagulopathy, as with prophylactic use of rFVIIa in prostatectomy or vascular surgery. 8. Clinical situations requiring prompt cessation of traumatic, surgical, or spontaneous bleeding in non-coagulopathic patients where hemorrhage extension is associated with significant adverse outcomes, as occurs with intracranial  hemorrhage, brain surgery, and pulmonary hemorrhage.