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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
1   The Hematology Department and Hemophilia Center, University of Florence, Florence, Italy
,
G Longo
1   The Hematology Department and Hemophilia Center, University of Florence, Florence, Italy
,
A Messori
1   The Hematology Department and Hemophilia Center, University of Florence, Florence, Italy
,
M Lee
2   The Baxter Healthcare Corp., Hyland Division, Glendale, California
,
G White
3   The University of North Carolina, Chapel Hill, North Carolina
,
P Mannucci
4   The A. Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy
,
The Recombinate Study Group › Author Affiliations
Further Information

Publication History

Received 30 January 1992

Accepted after revision 20 May 1992

Publication Date:
26 July 2018 (online)

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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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