Thromboreductin Dosage/Direction for Use

Posology: Treatment with Thromboreductin should be initiated by physicians experienced in the treatment of patients with essential thrombocythaemia.
The dosage of Thromboreductin has to be determined individually for each patient and needs to be controlled by the physician.
The recommended starting dose of Thromboreductin is 1.0 mg per day. The starting dose should be maintained for at least one week. After one week, the dose can be adjusted individually to obtain the lowest dose necessary to keep the platelet count <600 x 10⁹/l. The ideal platelet count lies between 150 x 10⁹/l and 400 x 10⁹/l.
An increase of the daily dose should not exceed 0.5 mg per week and the maximum single dose should not exceed 2.5 mg.
The effect of treatment with Thromboreductin should be controlled regularly (see Precautions).
Upon treatment initiation, the platelet count should be measured weekly until the individual optimal response is reached (normalisation of platelet count or a reduction to <600 x 10⁹/l). Afterwards the platelet count should be controlled in regular intervals according to the physicians' discretion.
Normally, a decrease of the platelet count can be seen within 14 to 21 days after treatment initiation. In most patients an adequate therapeutic response can be reached and maintained with a dose between 1 and 3 mg per day.
Thromboreductin is intended for continuous use. Upon discontinuation of Thromboreductin, platelet counts will increase within 4 to 8 days and within 10 to 14 days, pre-therapy values are reached.
Elderly: Age-specific dose changes were not necessary for the treatment of elderly patients with anagrelide.
Renal impairment: There are no specific pharmacokinetic data available for this patient population. Therefore the potential risks and benefits of anagrelide therapy in patients with renal insufficiency should be assessed before treatment is commenced (see Contraindications, Precautions and Pharmacology: Pharmacodynamics under Actions). Treatment with anagrelide in patients with moderate or severe renal insufficiency (creatinine clearance <50 ml/min) is contraindicated (see Contraindications).
Hepatic impairment: There are no specific pharmacokinetic data available for this patient population. Hepatic metabolism represents the most important path for drug clearance and liver function and may therefore be expected to influence this process. Potential risks and advantages of a therapy with anagrelide have to be considered prior to a treatment in patients with mild hepatic impairment (see Contraindications and Precautions). Treatment with anagrelide in patients with moderate or severe hepatic insufficiency is contraindicated (see Contraindications).
Paediatric population: The safety and efficacy of anagrelide in children aged up to 18 years has not been established. Currently available data are described in Pharmacology: Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: For oral use. Thromboreductin capsules must be swallowed whole with a small amount of liquid.