Active Ingredient: Hydroxycarbamide
Hydroxycarbamide indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 9 months of age.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in months is ≥ 9, oral, 15 milligrams hydroxycarbamide per kilogram of body weight, once daily, over the duration of 8 weeks. Afterwards, in case that patient age in months is ≥ 9, oral, between 20 milligrams hydroxycarbamide per kilogram of body weight and 35 milligrams hydroxycarbamide per kilogram of body weight, once daily. The maximum allowed total dose is 35 milligrams hydroxycarbamide per kilogram of body weight daily.
The posology should be based on the patient’s body weight (kg).
The usual starting dose of hydroxycarbamide is 15 mg/kg/day and the usual maintenance dose is between 20-25 mg/kg/day. The maximum dose is 35 mg/kg/day. Full blood cell count with white cell differential and reticulocyte count should be monitored once a month for the first 2 months following treatment initiation.
A target absolute neutrophil count 1,500–4,000/μL should be aimed for, whilst maintaining platelet count >80,000/μL. If neutropenia or thrombocytopenia occurs, hydroxycarbamide dosing should be temporarily withheld and full blood cell count with white cell differential should be monitored weekly. When blood counts have recovered, hydroxycarbamide should be reinstated at a dose 5 mg/kg/day lower than the dose given before onset of cytopenias.
If dose escalation is warranted based on clinical and laboratory findings, the following steps should be taken:
Once a maximum tolerated dose is established, laboratory safety monitoring should include full blood cell count with white cell differential, reticulocyte count, and platelet count every 2-3 months.
Red blood cell (RBC), mean cell volume (MCV), and foetal haemoglobin (HbF) levels should be monitored for evidence of consistent or progressive laboratory response. However, a lack of increase in MCV, HbF, or both, is not an indication to discontinue therapy if the patient responds clinically (e.g. decreased incidence of pain or hospitalisation).
A clinical response to treatment with hydroxycarbamide may take 3-6 months and therefore, a 6-month trial on the maximum tolerated dose is required prior to considering discontinuation due to treatment failure (whether due to lack of adherence or failure to respond to therapy).
Elderly patients may be more sensitive to the myelosuppressive effects of hydroxycarbamide, and may require a lower dosage regimen.
Hydroxycarbamide may be taken with or after meals at any time of the day but patients should standardise the method of administration and time of day.
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