Possible severe, sometimes life-threatening or fatal, adverse effects.
Limit to Qualified Personnel
Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy. (See Adequate Patient Evaluation and Monitoring under Cautions.)
Carcinogenicity
Hydroxyurea is genotoxic and is a presumed human carcinogen; also, mutagenic and clastogenic in vitro.
Secondary leukemias have been reported in patients receiving long-term therapy for myeloproliferative disorders (e.g., polycythemia vera, thrombocythemia).
Carefully consider risks of developing secondary malignancies against the benefits of therapy. (See Carcinogenicity under Cautions.)
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