Posology : מינונים

4.2    Posology and method of administration

Posology
Therapy should only be conducted by a physician experienced in oncology or haematology. Doses are based on real or ideal bodyweight of the patient, whichever is the less.

In CML hydroxycarbamide is usually given at an initial dose of 40 mg/kg daily dependent on the white cell count. The dose is reduced by 50 % (20 mg/kg daily) when the white cell count has dropped below 20 x 109/l. The dose is then adjusted individually to keep the white cell count at 5 – 10 x 109/l.
The hydroxycarbamide dose should be reduced if white cell counts fall below 5 x 109/l, and increased if white cell counts > 10 x 109/l are observed.
If the white cell count falls below 2.5 x 109/l, or the platelet count below 100 x 109/l, therapy should be interrupted until the counts rise significantly towards normal.

An adequate trial period for determining the antineoplastic effect of Hydroxyurea medac is six weeks.
Therapy should be interrupted indefinitely if there is significant progress of the disease. If there is significant clinical response therapy may be continued indefinitely.
In essential thrombocythaemia, hydroxycarbamide is usually given at starting doses of 15 mg/kg/day with dose adjustment to maintain a platelet count below 600 x 109/l without lowering the white blood cell count below 4 x 109/l.

In polycythaemia vera, hydroxycarbamide should be started at a dose of 15 – 20 mg/kg/day. The hydroxycarbamide dose should be adjusted individually to maintain the haematocrit below 45 % and platelet count below 400 x 109/l. In most patients this can be achieved with hydroxycarbamide given continuously at average daily doses of 500 to 1,000 mg.

If haematocrit and platelet count can be sufficiently controlled therapy may be continued indefinitely.

Paediatric population
The safety and efficacy of in children and adolescents under the age of 18 years have not yet been established.

Elderly
Elderly patients may be more sensitive to the effects of hydroxycarbamide, and may require a lower dose regimen.

Impaired renal and/or liver function
No data are available. Dose recommendation cannot be given to patients with impaired renal and/or liver function (see section 4.4).

Method of administration

The capsules should be swallowed whole and not be allowed to disintegrate in the mouth.