Cases of haemolytic anaemia in patients treated with hydroxycarbamide for myeloproliferative diseases have been reported. The morphologic change resembles pernicious anaemia, but is not related to vitamin B12 or folic acid deficiency. Megaloblastic erythropoiesis, which is self-limiting, is often seen early in the course of hydroxycarbamide therapy. In case of anaemia before or during ongoing treatment red blood cells may be replaced when needed. If the white cell count falls below 2.5 x 10 9/l, or the platelet count below 100 x 10 9/l, therapy should be interrupted until the counts rise significantly towards normal. The control interval should be individualised, but is normally once a week. Complete blood counts including determination of haemoglobin level, total leukocyte differentiation counts, and platelet counts should be performed regularly also after the individual optimal dose has been established. Thrombocytopenia and anaemia occur less frequently and are rare without preceding leucopenia. Hydroxycarbamide can cause bone marrow depression with leucopenia as the first and most commonly occurring sign. The capsules should be swallowed whole and not be allowed to disintegrate in the mouth. Dose recommendation cannot be given to patients with impaired renal and/or liver function (see section 4.4). If haematocrit and platelet count can be sufficiently controlled therapy may be continued indefinitely.īecause of the rarity of these conditions in children, dose regimens have not been established.Įlderly patients may be more sensitive to the effects of hydroxycarbamide, and may require a lower dose regimen. In most patients this can be achieved with hydroxycarbamide given continuously at average daily doses of 500 to 1,000 mg. The hydroxycarbamide dose should be adjusted individually to maintain the haematocrit below 45 % and platelet count below 400 x 10 9/l. In polycythaemia vera hydroxycarbamide should be started at a dose of 15 – 20 mg/kg/day. 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 10 9/l without lowering the white blood cell count below 4 x 10 9/l. If there is significant clinical response therapy may be continued indefinitely. Therapy should be interrupted indefinitely if there is significant progress of the disease.
PROCESSING OF CELL COUNT BY IMAGE PRO PLUS TRIAL
If the white cell count falls below 2.5 x 10 9/l, or the platelet count below 100 x 10 9/l, therapy should be interrupted until the counts rise significantly towards normal.Īn adequate trial period for determining the antineoplastic effect of Hydroxycarbamide medac is six weeks. The hydroxycarbamide dose should be reduced if white cell counts fall below 5 x 10 9/l and increased if white cell counts > 10 x 10 9/l are observed. The dose is then adjusted individually to keep the white cell count at 5 – 10 x 10 9/l. The dose is reduced by 50 % (20 mg/kg daily) when the white cell count has dropped below 20 x 10 9/l.
In CML hydroxycarbamide is usually given at an initial dose of 40 mg/kg daily dependent on the white cell count. Doses are based on real or ideal bodyweight of the patient, whichever is the less. Therapy should only be conducted by a physician experienced in oncology or haematology. Date of first authorisation/renewal of the authorisation 6.6 Special precautions for disposal and other handling.4.7 Effects on ability to drive and use machines.
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