From the FDA Drug Label
2 DOSAGE AND ADMINISTRATION
- 1 Dosing Information Hydroxyurea is used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases. Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. Base all dosage on the patient’s actual or ideal weight, whichever is less. ... Creatinine Clearance (mL/min) Recommended Hydroxyurea Capsules Initial Dose (mg/kg once daily) ≥60 15 <60 or ESRD* 7.5
The initial dose of Hydroxyurea is 15 mg/kg once daily for patients with a creatinine clearance of ≥60 mL/min, and 7.5 mg/kg once daily for patients with a creatinine clearance of <60 mL/min or with end-stage renal disease (ESRD) 1.
From the Research
The typical starting dose of hydroxyurea is 15 mg/kg/day as a single daily dose, as this dose has been shown to be effective in increasing fetal hemoglobin levels and reducing the frequency of vaso-occlusive episodes with minimal side effects 2.
Key Considerations
- The dose should be individualized based on the patient's condition, body weight, and renal function.
- Hydroxyurea therapy requires regular monitoring of blood counts, as the medication can cause myelosuppression.
- Blood counts should be checked every 2 weeks initially, then monthly once a stable dose is established.
- The therapeutic goal is to achieve the desired clinical effect, such as reducing sickle cell crises or controlling elevated white blood cell counts in myeloproliferative disorders, while maintaining acceptable blood counts.
Dose Adjustment
- The dose can be gradually increased by 5 mg/kg/day every 8-12 weeks if needed and tolerated, up to a maximum of 35 mg/kg/day.
- Patients should be advised to take hydroxyurea with food to minimize gastrointestinal side effects and maintain adequate hydration throughout treatment.
Recent Evidence
- A recent study published in 2021 found that a computer algorithm-based hydroxyurea dosing can facilitate titration to maximum tolerated dose in sickle cell anemia, with significant increases in fetal hemoglobin levels and reductions in direct bilirubin and alanine aminotransferase levels 3.
- Another study published in 2024 found that there is clinical equipoise regarding the most appropriate hydroxyurea dosing regimen in adults with sickle cell disease, with no significant difference in vaso-occlusive crisis rate between escalated and fixed low-dose studies 4.