Pharmacokinetic Properties of Recombinant Factor VIII Compared with a Monoclonally Purified Concentrate (Hemofil® M)

M Morfini; G Longo; A Messori; M Lee; G White; P Mannucci; The Recombinate Study Group

doi:10.1055/s-0038-1646292

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1992; 68(04): 433-435
DOI: 10.1055/s-0038-1646292

Original Article

Schattauer GmbH Stuttgart

Pharmacokinetic Properties of Recombinant Factor VIII Compared with a Monoclonally Purified Concentrate (Hemofil^® M)

M Morfini

¹The Hematology Department and Hemophilia Center, University of Florence, Florence, Italy

,

G Longo

¹The Hematology Department and Hemophilia Center, University of Florence, Florence, Italy

,

A Messori

¹The Hematology Department and Hemophilia Center, University of Florence, Florence, Italy

,

M Lee

²The Baxter Healthcare Corp., Hyland Division, Glendale, California

,

G White

³The University of North Carolina, Chapel Hill, North Carolina

,

P Mannucci

⁴The A. Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy

,

The Recombinate Study Group

› Author Affiliations

Abstract

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Summary

A recombinant FVIII preparation, Recombinate^™, was compared with a high-purity plasma-derived concentrate, Hemofil^® M, in 47 hemophilia A patients in a cross-over evaluation of pharmacokinetic properties. The recombinant material showed a significantly lower clearance, volume of distribution, and higher in vivo recovery, but a similar half-life to the plasma-based product.

In a comparison with reported data from other standard concentrates, the recombinant preparation exhibited potentially better pharmacokinetic properties in that its clearance was slower and its half-life was longer.

We conclude that the recombinant DNA method of preparation does not adversely affect the biological and pharmacological characteristics of the factor VIII molecule.

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References

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