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

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.

• Authors: Jill C Krisl, Holly E Meadows, Charles S Greenberg, Joseph E Mazur
• Journal: The Annals of pharmacotherapy (Ann Pharmacother) Vol. 45 Issue 11 Pg. 1433-8 (Nov 2011) ISSN: 1542-6270 [Electronic] United States
• PMID: 22009992 (Publication Type: Journal Article, Review)

Chemical References

• Recombinant Proteins
• recombinant FVIIa
• Factor VIIa

Topics

• Factor VIIa (adverse effects, therapeutic use)
• Hemorrhage (drug therapy, prevention & control)
• Humans
• International Normalized Ratio (methods)
• Liver Failure (physiopathology, surgery, therapy)
• Prospective Studies
• Prothrombin Time (methods)
• Recombinant Proteins (adverse effects, therapeutic use)
• Retrospective Studies