Document Detail

Prophylaxis in factor IX deficiency product and patient variation.
MedLine Citation:
PMID:  12694518     Owner:  NLM     Status:  MEDLINE    
To determine the dosing needed to maintain a prophylactic level of factor IX (FIX) >/=2%, 15 non-inhibitor severe (</=1% FIX) deficient subjects participated in a double-blind, two-period crossover study to assess the pharmacokinetics of two FIX concentrates, Mononine (pd-FIX), an ultra-high-purity plasma-derived concentrate, and BeneFix (r-FIX), a recombinant product. The median recovery in the pd-FIX group was 1.67 IU dL(-1) per IU kg-1+/-1.07 vs. 0.86 IU dL(-1) per IU kg(-1)+/-0.32 in the r-FIX group (P = 0.0002). The median half-life for pd-FIX was 12.9 +/-1.7 h compared with 13.7 +/- 2.9 h for r-FIX (P = 0.016). Fitted dose activity curves were computer-simulated to depict multiple-dose activity curves for each patient with each product that would maintain prophylactic levels of >/=2%. Based on pharmacokinetic analysis the median amount of concentrate needed to maintain a prophylactic level >/=2% for 30 days when administered every third day is 677 IU kg(-1) pd-FIX (range 388-6005 IU kg(-1) pd-FIX) compared with 1168 IU kg(-1) r-FIX (range 268-13085 IU kg(-1) r-FIX). The median cost for 30 days of prophylaxis of an average 25-kg 8-year-old child at the current University of Iowa Price (0.87 US dollars Mononine/0.86 US dollars BeneFix as of December 2002) if given every third day would be 19,972 US dollars and 34,456 US dollars for r-FIX. However, because of wide inter-patient variability in recovery and half-life, pharmacokinetic evaluation of each patient is necessary to determine the appropriate dosing schedule and product best suited for prophylaxis.
C T Kisker; A Eisberg; B Schwartz;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Haemophilia : the official journal of the World Federation of Hemophilia     Volume:  9     ISSN:  1351-8216     ISO Abbreviation:  Haemophilia     Publication Date:  2003 May 
Date Detail:
Created Date:  2003-04-15     Completed Date:  2003-08-12     Revised Date:  2009-10-21    
Medline Journal Info:
Nlm Unique ID:  9442916     Medline TA:  Haemophilia     Country:  England    
Other Details:
Languages:  eng     Pagination:  279-84     Citation Subset:  IM    
University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA.
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MeSH Terms
Cost-Benefit Analysis
Cross-Over Studies
Double-Blind Method
Drug Administration Schedule
Drug Costs
Factor IX / administration & dosage*,  economics,  pharmacokinetics
Hemarthrosis / etiology,  prevention & control
Hemophilia B / blood,  complications,  drug therapy*
Middle Aged
Recombinant Proteins / administration & dosage,  economics,  pharmacokinetics
Reg. No./Substance:
0/Mononine; 0/Recombinant Proteins; 9001-28-9/Factor IX

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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