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Thalidomide is distributed into human semen after oral dosing.
S K Teo1, J L Harden, A B Burke
1Celgene Corporation, Warren, New Jersey 07059, USA. steo@celgene.com
Drug Metabolism and Disposition: the Biological Fate of Chemicals
|September 19, 2001
Summary
Thalidomide was detected in the plasma and semen of human immunodeficiency virus-seropositive patients. Due to unknown birth defect risks, barrier contraception is recommended for male patients on thalidomide therapy.
Area of Science:
- Pharmacology
- Reproductive Health
- Infectious Diseases
Background:
- Thalidomide is used to treat certain conditions, but its effects on male reproductive health, particularly in HIV-seropositive individuals, require investigation.
- Understanding thalidomide distribution in bodily fluids is crucial for assessing potential risks.
- Human immunodeficiency virus (HIV) infection can impact drug pharmacokinetics.
Purpose of the Study:
- To quantify thalidomide levels in plasma and semen of HIV-seropositive patients.
- To explore the correlation between plasma and semen thalidomide concentrations.
- To inform safety recommendations regarding reproductive exposure to thalidomide.
Main Methods:
- A double-blind, placebo-controlled study involving HIV-seropositive patients receiving oral thalidomide (100 mg/day for 8 weeks).
- Collection of plasma and semen samples at specified intervals (baseline, weeks 4, 8, 12).
- Analysis of samples using liquid chromatography/tandem mass spectrometry (LC/MS/MS) with atmospheric pressure chemical ionization.
Main Results:
- Thalidomide was detectable in both plasma (10-350 ng/ml) and semen (10-250 ng/g) of two patients at weeks 4 and 8.
- A correlation was observed between plasma and semen thalidomide levels.
- Higher semen levels may occur with doses exceeding 100 mg/day.
Conclusions:
- Thalidomide distributes into semen in HIV-seropositive patients.
- The potential teratogenic risk from semen exposure is unknown, necessitating caution.
- Male patients undergoing thalidomide therapy should utilize barrier contraception to prevent potential exposure.
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