Pharmacokinetic study of human natural beta-interferon in patients with end-stage renal failure.
OBJECTIVE
Although human natural beta-interferon (beta-IFN) is currently used in the treatment of a number diseases, there have been no published studies of the pharmacokinetics and pharmacodynamics of beta-IFN in patients with end-stage renal failure.


METHODS
Five maintenance hemodialysis patients with chronic hepatitis C (4 men and 1 woman) were enrolled in this study.


METHODS
For the pharmacokinetic study, blood samples were obtained from a forearm vein at intervals, before infusion and 0, 3, 5, 10, 20, 30, and 40 minutes after a 15-minute intravenous infusion of human natural beta-IFN (Feron, Toray Industries, Inc., Tokyo) at a dose of 600 MIU.


RESULTS
Intravenous beta-IFN was administrated safely to all five patients. The plasma half-life of beta-IFN was found to be 6.91 +/- 2.80 (mean +/- SD) minutes. The initial volume of distribution was found to be 0.49 +/- 0.02 l/kg.


CONCLUSIONS
A 15-minute intravenous infusion of human natural beta-IFN was safely administered to the hemodialysis patients. This pharmacokinetic study showed that it is not necessary to reduce the dosage in patients with end-stage renal failure.
Nakayama
H
H
Department of Renal Medicine, Saiyu Soka Hospital, Saitama, Japan. hnakayama@tmch.or.jp
Shiotani
S
S
Akiyama
S
S
Gotoh
H
H
Tani
M
M
Akine
Y
Y
D000410:Alanine Transaminase / Q000097:blood / Q000187:drug effects; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D001219:Aspartate Aminotransferases / Q000097:blood / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications / Q000628:therapy; D006801:Humans; D007260:Infusion Pumps; D016899:Interferon-beta / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D007676:Kidney Failure, Chronic / Q000150:complications / Q000378:metabolism*; D007962:Leukocytes / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D006435:Renal Dialysis; D012720:Severity of Illness Index; D013997:Time Factors
D000998:Antiviral Agents; D016899:Interferon-beta; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase