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
Patient Medication Guide - Droxia
Patient Medication Guide - HYDREA
Updated January 2023