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Hydroxyurea (Oral)

Myelosuppression and malignancies

  • Myelosuppression: Hydroxyurea may cause severe myelosuppression. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary.

    Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies


MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Hydroxyurea is a cytotoxic and myelosuppressive agent and requires close supervision. Some patients treated at the recommended initial dose of 15 mg/kg/day have experienced severe or life threatening myelosuppression, requiring interruption of treatment and dose reduction.
  • This drug should not be given initially or therapy should be stopped if bone marrow function is markedly depressed (neutrophils below 2000 cells/mm3, a platelet count below 80,000/mm3, a hemoglobin level below 4.5 g/dL, or reticulocytes below 80,000/mm3 when the hemoglobin concentration is below 9 g/dL. Reinitiation of therapy should follow product insert guidelines. (See product insert for more details under WARNINGS. )

Patient Counseling Information

Droxia

Hydrea

Hydroxyurea

Medication Guides

Patient Medication Guide - Droxia

Patient Medication Guide - HYDREA

Patient Medication Guide - Siklos

Package Inserts

Siklos

Droxia

Hydrea

Additional Information

Updated January 2023