Details

Epocrine solution for injection 2000ME, 1ml No. 10

anemia in patients with chronic renal failure (including those on hemodialysis);

prevention and treatment of anemia in patients with solid tumors resulting from antitumor therapy;

prevention and treatment of anemia caused by the use of zidovudine in HIV-infected patients (AIDS);

prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin's lymphomas, chronic lymphocytic leukemia, in patients with rheumatoid arthritis;

prevention and treatment of anemia in premature babies born with low body weight (up to 1500 g);

to reduce the volume of blood transfused during major surgical interventions and acute blood loss.

When treating anemia in patients with chronic renal failure, EpocrinЃ is administered subcutaneously or intravenously; for patients on hemodialysis - through an arteriovenous shunt at the end of the dialysis session. When the method of administration is changed, the drug is administered in the same dose, then the dose is adjusted if necessary (with the subcutaneous administration of the EpocrinЃ drug, to achieve the same therapeutic effect, a dose of 20-30% less is required than with the intravenous administration). Treatment with Epocrine includes 2 stages.

1. Stage of correction. With subcutaneous administration of EpocrinЃ, the initial dose is 30 IU / kg 3 times a week. For intravenous administration of EpocrinЃ, the initial dose is 50 IU / kg. The correction period lasts until the optimal hemoglobin level (100-120 g / l in adults and 95-110 g / l in children) and hematocrit (30-35%) are reached. These indicators need to be monitored weekly.

The following situations are possible:

Increase in hematocrit from 0.5% to 1% per week Do not change the dose until optimal values ??are reached The rate of increase in hematocrit is less than 0.5% per week The rate of increase in hematocrit is 1.5 times higher The rate of increase in hematocrit is more than 1% per week The rate of increase in hematocrit is more than 1% per week The rate of increase in hematocrit is more than 1% per week Hematocrit remains low or decreases It is necessary to analyze the causes of resistance

The effectiveness of therapy depends on a properly selected individual treatment regimen.

2. Stage of maintenance therapy. To maintain the hematocrit at a level of 30-35%, the dose of EpocrinЃ used at the correction stage should be reduced by 1.5 times. Then the maintenance dose of EpocrinЃ is selected individually, taking into account the dynamics of hematocrit and hemoglobin. After stabilization of hematological parameters, it is possible to switch to the administration of EpocrinЃ once every 1-2 weeks.

In the prevention and treatment of anemia in patients with solid tumors , it is recommended to determine the level of endogenous erythropoietin before using the drug. When the concentration of serum erythropoietin is less than 200 IU / ml, the initial dose of EpocrinЃ for intravenous administration is 150 IU / kg. With subcutaneous administration, the initial dose of EpocrinЃ can be reduced to 100 IU / kg. In the absence of a response, the dose may be increased to 300 IU / kg. Further dose increases seem to be inappropriate. It is not recommended to prescribe EpocrinЃ to patients with an endogenous serum erythropoietin content of more than 200 IU / ml.

For the prevention and treatment of anemia caused by the use of zidovudine in patients with HIV infection, intravenous administration of EpocrinЃ at a dose of 100-150 IU / kg 3 times a week is effective provided that the level of serum endogenous erythropoietin is less than 500 IU / ml, and the dose of zidovudine is less than 4.2 g per week. With subcutaneous administration, the dose of EpocrinЃ can be reduced by 1.5 times.

The feasibility of using EpocrinЃ for the prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin's lymphomas, chronic lymphocytic leukemia is due to inadequate synthesis of endogenous erythropoietin against the background of anemia. When the hemoglobin content is less than 100 g / l and serum erythropoietin is less than 100 IU / ml, EpocrinЃ is administered subcutaneously at an initial dose of 100 IU / kg 3 times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly. If necessary, the dose of EpocrinЃ is adjusted upward or downward every 3-4 weeks. If, upon reaching a weekly dose of 600 IU / kg, an increase in hemoglobin content is not observed, EpocrinЃ should be canceled, because its further use is ineffective.

The expediency of using the EpocrinЃ drug for the prevention and treatment of anemia in patients with rheumatoid arthritis is due to the fact that in this disease there is a suppression of the synthesis of endogenous erythropoietin under the influence of an increased concentration of pro-inflammatory cytokines. EpocrinЃ is administered subcutaneously at a dose of 50-75 IU / kg 3 times a week. With an increase in hemoglobin content of less than 10 g / l after 4 weeks of treatment, the dose of EpocrinЃ is increased to 150-200 IU / kg 3 times a week. Further dose increases seem to be inappropriate.

For the prevention and treatment of anemia in premature infants born with low body weight , EpocrinЃ is administered subcutaneously at a dose of 200 IU / kg 3 times a week, starting from the 6th day of life until the target values ??of hemoglobin and hematocrit are achieved, but not more than 6 weeks ...

For the prevention of anemia in major surgical interventions and acute blood loss, EpocrinЃ is administered intravenously or subcutaneously 3 times a week at a dose of 100-150 IU / kg until the hematocrit and hemoglobin content normalize.

1 ml epoetin alfa (recombinant human erythropoietin) 2000 IU

Excipients : albumin (in the form of albumin, solution for infusion 10%) - 2.5 mg, sodium citrate pentasesquihydrate - 5.8 mg or sodium citrate dihydrate - 4.776 mg, sodium chloride - 5.84 mg, citric acid monohydrate - 0.057 mg, water d / i - up to 1 ml.

1 ml - glass ampoules (10) - contoured cell packaging (1) - cardboard packs.

partial red cell aplasia after previous therapy with any erythropoietin;

uncontrolled arterial hypertension;

inability to conduct adequate anticoagulant therapy;

period within 1 month after suffering myocardial infarction;

unstable angina;

an increased risk of deep vein thrombosis and thromboembolism as part of a pre-deposit blood collection program before surgery;

porphyria;

hypersensitivity to the components of the drug.

The drug should be prescribed with caution in patients with thrombosis (in history), malignant neoplasms, sickle cell anemia, in patients with moderate anemia without iron deficiency, in patients with refractory anemia, epilepsy and chronic liver failure.

The solution for intravenous and subcutaneous administration is transparent, colorless.

1 ml epoetin alfa (recombinant human erythropoietin) 2000 IU

Excipients : albumin (in the form of albumin, solution for infusion 10%) - 2.5 mg, sodium citrate pentasesquihydrate - 5.8 mg or sodium citrate dihydrate - 4.776 mg, sodium chloride - 5.84 mg, citric acid monohydrate - 0.057 mg, water d / i - up to 1 ml.

1 ml - glass ampoules (10) - contoured cell packaging (1) - cardboard packs.

Clinical and pharmacological group: Stimulant of erythropoiesis

Pharmaco-therapeutic group: Hematopoiesis stimulant

pharmachologic effect

Erythropoiesis stimulant, recombinant human erythropoietin, glycoprotein.

Activates mitosis and maturation of erythrocytes from erythrocyte progenitor cells. Recombinant epoetin alfa is synthesized in mammalian cells in which the gene encoding human erythropoietin is inserted. By its composition, biological and immunological properties, epoetin alfa is identical to natural human erythropoietin. The introduction of epoetin alfa leads to an increase in the level of hemoglobin and hematocrit, an improvement in the blood supply to tissues and the work of the heart.

The most pronounced effect of the use of epoetin alfa is observed in anemia caused by chronic renal failure.

In very rare cases, with prolonged use of epoetin alfa for the treatment of anemic conditions, the formation of neutralizing antibodies to erythropoietin can be observed with or without the development of partial red cell aplasia.

Pharmacokinetics

Absorption and distribution

After subcutaneous administration, the concentration of the active substance in the blood increases slowly, Cmax is reached within 12-18 hours. Bioavailability with subcutaneous administration is 25-40%.

Withdrawal

After subcutaneous administration, T1 / 2 is 16-24 hours.

After intravenous administration, T1 / 2 in healthy individuals and patients with uremia is 5-6 hours.

Indications for EpocrinЃ

anemia in patients with chronic renal failure (including those on hemodialysis);

prevention and treatment of anemia in patients with solid tumors resulting from antitumor therapy;

prevention and treatment of anemia caused by the use of zidovudine in HIV-infected patients (AIDS);

prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin's lymphomas, chronic lymphocytic leukemia, in patients with rheumatoid arthritis;

prevention and treatment of anemia in premature babies born with low body weight (up to 1500 g);

to reduce the volume of blood transfused during major surgical interventions and acute blood loss.

Dosage regimen