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HYDREA may damage spermatozoa and testicular tissueresulting in possible genetic abnormalitiesMales with female sexual partners of reproductive potential should use effective contraception during and after treatment with HYDREA for at least 1 year after therapysee Nonclinical Toxicology

Based on findings in animals and humansmale fertility may be compromised by treatment with HYDREAAzoospermia or oligospermiasometimes reversiblehas been observed in menInform male patients about the possibility of sperm conservation before the start of therapysee ADVERSE REACTIONS and Nonclinical Toxicology

Hydroxyurea is a human carcinogenIn patients receiving long-term hydroxyurea for myeloproliferative disorderssecondary leukemia has been reportedSkin cancer has also been reported in patients receiving long-term hydroxyureaAdvise protection from sun exposure and monitor for the development of secondary malignancies.

HYDREA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

Three mechanisms of action have been postulated for the increased effectiveness of concomitant use of hydroxyurea therapy with irradiation on squamous cellepidermoidcarcinomas of the head and neckIn vitro studies utilizing Chinese hamster cells suggest that hydroxyurea1is lethal to normally radioresistant S-stage cellsand2holds other cells of the cell cycle in the G1 or pre-DNA synthesis stage where they are most susceptible to the effects of irradiationThe third mechanism of action has been theorized on the basis of in vitro studies of HeLa cellsIt appears that hydroxyureaby inhibition of DNA synthesishinders the normal repair process of cells damaged but not killed by irradiationthereby decreasing their survival rateRNA and protein syntheses have shown no alteration.

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