Pharmaceutical combination preparations containing erythropoietin and iron preparations
AssigneeRoche Diagnostics GmbH
InventorPaul Lehmann
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Abstract
The present invention is directed to a pharmaceutical combination preparation comprising 2,000-7,000 U of recombinant human erythropoietin (EPO) and 5-20 mg of an Fe(III) complex, wherein the rhEPO and the Fe(III) complex may be present in separate administration forms or in an integrated administration form. The pharmaceutical preparation is used in the treatment of anemias or hemodialysis patients.
Claims34
A method for the treatment of hemodialysis patients or patients exhibiting anemia, comprising administering to a patient in need of such treatment effective amounts of erythropoietin and a physiologically tolerable iron preparation contained in a pharmaceutical combination preparation, wherein the pharmaceutical combination preparation contains about 2,000-7,000 U of erythropoietin and a quantity of iron preparation equivalent to about 1-20 mg of iron ions, wherein the erythropoietin and the iron preparation are administered both in the correction phase and the maintenance phase of iron therapy, wherein the iron doses are, independently, 1-20 mg/week in the correction phase and the maintenance phase and wherein the erythropoietin doses are, independently, up to 15,000 U/week in the correction phase and the maintenance phase.
A method for the treatment of hemodialysis patients exhibiting anemia, comprising
- (a) monitoring at least one parameter selected from the group consisting of ferritin concentration, iron concentration, transferrin concentration, transferrin saturation and transferrin/ferritin saturation in a body fluid sample from the patient to determine the at least one parameter with respect to a target range of about 100-300 μg/l for the ferritin concentration, about 10-20 μmol/l for the iron concentration, about 240-480 mg/dl for the transferrin concentration, about 20-40% for the transferrin saturation or about 5-40%×l/μg for the transferrin/ferritin saturation;
- (b) if the at least one parameter is determined to be less than the lower limit of the target range, administering erythropoietin and a physiologically tolerable iron preparation contained in a pharmaceutical combination preparation, which combination preparation contains about 2,000-7,000 U of erythropoietin and a quantity of iron preparation equivalent to about 1-20 mg of iron ions, to the patient in amounts sufficient to bring the at least one parameter within the target range;
- and thereafter
- (c) conducting maintenance treatments by administering the erythropoietin and iron preparation to the patient in amounts sufficient to keep the at least one parameter within the target range;
- wherein the erythropoietin and the iron preparation are administered both in the correction phase and the maintenance phase of iron therapy, wherein the iron doses are, independently, 1-20 mg/week in the correction phase and the maintenance phase and wherein the erythropoietin doses are, independently, up to 15,000 U/week in the correction phase and the maintenance phase.
A method for the treatment of patients exhibiting anemia, comprising
- (a) monitoring at least one parameter selected from the group consisting of ferritin concentration, transferrin receptor concentration, and the ratio of transferrin receptor concentration to ferritin concentration in a body fluid sample from the patient to determine the at least one parameter with respect to a target range of about 100-300 μg/l for the ferritin concentration, about 1500-2500 μg/l for the transferrin receptor concentration or greater than about 15 for the ratio of transferrin receptor concentration to ferritin concentration;
- (b) if the at least one parameter id determined to be less than the lower limit of the target range, administering erythropoietin and a physiologically tolerable iron preparation contained in a pharmaceutical combination preparation, which combination preparation contains about 2,000-7,000 U of erythropoietin and a quantity of iron preparation equivalent to about 1-20 mg or iron ions;
- in amounts sufficient to bring the at least one parameter within the target range;
- and thereafter
- (c) conducting maintenance treatments by administering the erythropoietin and iron preparation to the patient in amounts sufficient to keep the at least one parameter within the target range;
- wherein the erythropoietin and the iron preparation and administering both in the correction phase and the maintenance phase of iron therapy, wherein the iron doses are, independently, 1-20 mg/week in the correction phase and the maintenance phase and wherein the erythropoietin doses are, independantly, up to 15,000 U/week in the correction phase and the maintenance phase.
A pharmaceutical combination preparation suitable for the treatment of hemodialysis patients or patients exhibiting anemia, comprising about 2,000-7,000 U of erythropoietin and a physiologically tolerable iron preparation equivalent to about 1-20 mg or iron ions as a pharmaceutical formulation in a single container.
A method for the production of a pharmaceutical combination preparation useful for the treatment of hemodialysis patients, comprising formulating about 2,000-7,000 U of erythropoietin and a physiologically tolerable iron preparation equivalent to about 1-20 mg or iron ions in a single pharmaceutical packing unit.
Dependencies are inferred from the claim text.