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Droxia and Hydrea (hydroxyurea) capsules Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   March 2016 Summary View WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, HYDREA/DROXIA can cause fetal harm when administered to a pregnant woman. Hydroxyurea was embryotoxic and teratogenic in rats and rabbits at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis. Advise pregnant women of the potential risk to a fetus Advise females of reproductive potential to use effective contraception during and after treatment with HYDREA for at least 6 months after therapy. Advise males of reproductive potential to use effective contraception during and after treatment with HYDREA for at least 1 year after therapy. Live Vaccinations Avoid use of live vaccine in patients taking HYDREA. Concomitant use of Hydrea/Droxia with a live virus vaccine may potentiate the replication of the virus and/or may increase the adverse reaction of the vaccine because normal defense mechanisms may be suppressed by HYDREA/DROXIA. Vaccination with live vaccines in a patient receiving HYDREA/DROXIA may result in severe infection. Patient’s antibody response to vaccines may be decreased. Consider consultation with a specialist. ADVERSE REACTIONS Postmarketing Experience Reproductive System and Breast disorders: azoospermia, and oligospermia Metabolism and Nutrition disorders: anorexia, tumor lysis syndrome Hepatobiliary disorders: cholestasis, and hepatitis Adverse reactions observed with combined hydroxyurea and irradiation therapy are similar to those reported with the use of hydroxyurea or radiation treatment alone. These effects primarily include bone marrow depression (anemia and leukopenia), gastric irritation, and mucositis. Almost all patients receiving an adequate course of combined hydroxyurea and irradiation therapy will demonstrate concur

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