RT Journal Article
SR Electronic
T1 Thalidomide Is Distributed into Human Semen after Oral Dosing
JF Drug Metabolism and Disposition
JO Drug Metab Dispos
FD American Society for Pharmacology and Experimental Therapeutics
SP 1355
OP 1357
VO 29
IS 10
A1 Steve K. Teo
A1 Jill L. Harden
A1 Alison B. Burke
A1 Faruq H. Noormohamed
A1 Mike Youle
A1 Margaret A. Johnson
A1 Barry S. Peters
A1 David I. Stirling
A1 Steve D. Thomas
YR 2001
UL http://dmd.aspetjournals.org/content/29/10/1355.abstract
AB As part of a double-blind placebo-controlled study of the effect of thalidomide on body weight and the viral load of human immunodeficiency virus-seropositive patients, plasma and semen samples were analyzed for the presence of thalidomide. Patients were orally dosed with 100 mg of thalidomide/day for 8 weeks. Blood samples were obtained at baseline and weeks 4, 8, and 12, and semen was obtained at baseline and weeks 4 and 8. Samples were extracted with solid-phase cartridges and analyzed by liquid chromatography/tandem mass spectrometry using atmospheric pressure chemical ionization in the negative ion mode. Two of four patients taking thalidomide were able to provide semen samples. Both had detectable levels of thalidomide in their plasma (10–350 ng/ml) and semen (10–250 ng/g) at weeks 4 and 8. There was an apparent correlation between plasma and semen levels. Semen levels could be significantly greater for therapeutic doses of more than 100 mg/day. Since the threshold dose for birth defects and thalidomide exposure is not known, male patients are advised to use barrier contraception. The American Society for Pharmacology and Experimental Therapeutics