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Ann Pharmacother. 2011 Nov;45(11):1433-8. doi: 10.1345/aph.1Q207. Epub 2011 Oct 18.

Clinical usefulness of recombinant activated factor VII in patients with liver failure undergoing invasive procedures.

Author information

1
Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA. krisl@musc.edu

Abstract

OBJECTIVE:

To evaluate the use of recombinant activated factor VII (rFVIIa) in patients with liver failure undergoing invasive procedures.

METHODS:

An OVID/MEDLINE and PubMed search (1997-June 2011) was performed to identify literature on the use of rFVIIa to reduce bleeding risk in patients with liver failure undergoing invasive procedures.

STUDY SELECTION AND DATA EXTRACTION:

English-language data evaluating the efficacy of rFVIIa to reverse coagulopathies prior to invasive procedures in patients with liver disease were included.

DATA SYNTHESIS:

Following administration of rFVIIa, prothrombin time (PT) and international normalized ratio (INR) response is within 30 minutes. Doses ranging from 20 to 120 μg/kg have been studied, with a reduction in PT seen in a dose-dependent manner. One study in patients with no bleeding administered 5, 20, and 80 μg/kg sequentially during a 24-day period. All doses provided reversal of prolonged PT within 10 minutes, and the duration was dose-dependent. In a study of 15 patients with fulminant liver failure, requiring intracranial pressure monitor placement, a rFVIIa dose of 40 μg/kg was compared to fresh frozen plasma. In patients who received rFVIIa, the PT and INR normalized, compared to none of the patients in the fresh frozen plasma group.

CONCLUSIONS:

Retrospective and prospective data demonstrate that rFVIIa effectively reverses elevated PT and INR, reducing the risk of bleeding and safely facilitating invasive procedures. Based on available data, a dose of 20-40 μg/kg 30 minutes prior to an invasive procedure should be considered in patients with acute or chronic liver failure at risk for bleeding complications. A major limitation of rFVIIa use is the high cost of therapy. A prospective, randomized trial could help determine the appropriate dose of rFVIIa, timing of dose in relationship to procedure, and usefulness of subsequent doses.

PMID:
22009992
DOI:
10.1345/aph.1Q207
[Indexed for MEDLINE]

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