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Prophylaxis in factor IX deficiency product and patient variation by C.T. Kisker; A. Eisberg; B. Schwartz; the Mononine Study Group is a Medicine article available to read on EtoBox.

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**Summary.** 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 Universit

Who reads Prophylaxis in factor IX deficiency product and patient variation?

Author

C.T. Kisker; A. Eisberg; B. Schwartz; the Mononine Study Group

Publisher

John Wiley and Sons; Wiley (Blackwell Publishing); Blackwell Publishing Inc.; Wiley (ISSN 1351-8216)

Published

2003

Language

EN

Field

Medicine (Health Sciences)