Eralfon solution for injection 2000ME, 0.5ml No. 6

• Treatment of anemia associated with chronic renal failure in adult patients on hemo- or peritoneal dialysis, or for whom dialysis is indicated; in children on hemodialysis.

• Treatment of anemia in cancer patients (receiving or not receiving chemotherapy) with non-myeloid tumors.

• Prevention of anemia in cancer patients with nonmyeloid tumors receiving a long course of chemotherapy.

• Treatment of anemia in HIV-infected patients receiving zidovudine therapy (with an endogenous erythropoietin level of ?500 IU / ml).

• As part of a pre-deposit program before major surgery in patients with a hematocrit level of 33-39%, to facilitate collection of autologous blood and reduce the risk associated with the use of allogeneic blood transfusions (if the expected need for transfused blood is higher than the amount that can be obtained without the use of epoetin alpha).

• Before major surgery with expected average blood loss (2-4 units or 900-1800 ml) in adult patients with mild or moderate anemia (hemoglobin> 10 and? 13 g / dL) to reduce the need for allogeneic blood transfusions and improve the recovery of erythropoiesis.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Enter s / c or i / v. A single dose of 30-100 U / kg, the frequency of administration and the duration of use are set individually.

For one syringe:

Active ingredient: epoetin alfa (human recombinant erythropoietin) - 2000 IU

Excipients : sodium chloride - 2.92 mg, sodium citrate pentasesquihydrate - 2.9 mg or sodium citrate dihydrate - 2.388 mg, albumin solution (in terms of dry albumin) - 1.25 mg, citric acid monohydrate - 0.0285 mg, water d / i - up to 0.5 ml.

• Uncontrolled arterial hypertension, hypersensitivity to epoetin alfa.

• It is contraindicated in severe vascular pathology (including coronary, carotid, cerebral, peripheral) and with recent myocardial infarction or acute cerebrovascular accident before a major surgical operation outside the pre-deposit program using autologous blood.

Clinical and pharmacological group: Stimulant of erythropoiesis

Pharmaco-therapeutic group: Hematopoiesis stimulant

pharmachologic effect

Recombinant human erythropoietin is a purified glycoprotein. Stimulates erythropoiesis. It is synthesized in mammalian cells into which the gene encoding human erythropoietin is inserted. Biological and immunological properties are identical to human erythropoietin excreted from urine. The synthesis of endogenous erythropoietin is carried out in the kidneys and depends on the level of blood oxygenation.

Pharmacokinetics

After subcutaneous administration, the concentration of the active substance in the plasma increases slowly, reaching a maximum level after 12-18 hours.

After repeated intravenous administration, T1 / 2 in healthy adults is 4 hours, in patients with renal failure - about 6 hours; in children - about 6 hours.

Indications

• Treatment of anemia associated with chronic renal failure in adult patients on hemo- or peritoneal dialysis, or for whom dialysis is indicated; in children on hemodialysis.

• Treatment of anemia in cancer patients (receiving or not receiving chemotherapy) with non-myeloid tumors.

• Prevention of anemia in cancer patients with nonmyeloid tumors receiving a long course of chemotherapy.

• Treatment of anemia in HIV-infected patients receiving zidovudine therapy (with an endogenous erythropoietin level of ?500 IU / ml).

• As part of a pre-deposit program before major surgery in patients with a hematocrit level of 33-39%, to facilitate collection of autologous blood and reduce the risk associated with the use of allogeneic blood transfusions (if the expected need for transfused blood is higher than the amount that can be obtained without the use of epoetin alpha).

• Before major surgery with expected average blood loss (2-4 units or 900-1800 ml) in adult patients with mild or moderate anemia (hemoglobin> 10 and? 13 g / dL) to reduce the need for allogeneic blood transfusions and improve the recovery of erythropoiesis.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Enter s / c or i / v. A single dose of 30-100 U / kg, the frequency of administration and the duration of use are set individually.

Side effect

Flu-like syndrome: dizziness, drowsiness, fever, headache, pain in joints and muscles are possible (mainly at the beginning of treatment).

From the side of the cardiovascular system: dose-dependent increase in blood pressure is possible; worsening of the course of arterial hypertension (most often in patients with chronic renal failure); in some cases - hypertensive crises, malignant arterial hypertension with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic seizures.

From the hematopoietic system: rarely - thrombocytosis.

On the part of the coagulation system: in some cases - shunt thrombosis (in patients on hemodialysis with a tendency to hypotension or in the presence of stenoses, aneurysms).

From the urinary system: possible hyperkalemia, hyperphosphatemia, an increase in the concentration of urea, creatinine, uric acids in the blood plasma (in patients with chronic renal failure).

Allergic reactions: in some cases - mild or moderate skin rash, eczema, urticaria, itching, angioedema.

Local reactions: possible redness, burning sensation, mild or moderate soreness at the injection site (more often occur with subcutaneous injection).

Others: rarely - potentially serious complications associated with respiratory failure or with a decrease in blood pressure; immune reactions (has a minimal ability to induce the formation of antibodies).

Contraindications for use

• Uncontrolled arterial hypertension, hypersensitivity to epoetin alfa.

• It is contraindicated in severe vascular pathology (including coronary, carotid, cerebral, peripheral) and with recent myocardial infarction or acute cerebrovascular accident before a major surgical operation outside the pre-deposit program using autologous blood.

Application during pregnancy and lactation

The safety of using epoetin alfa during pregnancy and lactation has not been established.

Application for violations of liver function

When used in patients with impaired liver function, it is possible to slow down the biotransformation of epoetin alfa and a pronounced increase in erythropoiesis. The safety of using epoetin alfa in this category of patients has not been established.

Application for impaired renal function

In patients with chronic renal failure and clinically severe coronary artery disease or congestive heart failure, the maintenance hemoglobin level should not exceed the upper limit of the optimal recommended level (no more than 10-12 g / dL in adults).

special instructions

Use with caution in patients with a history of convulsive reactions; patients with an increased risk of thrombosis or other vascular complications require careful medical supervision.

Use with caution for gout.

Before starting use, it should be ensured that patients with arterial hypertension have received effective antihypertensive therapy.

While using it, it is necessary to control the blood pressure level, paying attention to the occurrence or intensification of unusual headaches. In this case, it may be necessary to correct the therapy or prescribe antihypertensive drugs. If, despite adequate therapy, blood pressure does not decrease, epoetin alfa should be discontinued.

Before starting the use of epoetin alfa, the state of the iron depot in the body should be assessed. In most patients with chronic renal failure, in cancer and HIV-infected patients, the level of ferritin in the blood plasma decreases simultaneously with an increase in hematocrit. Ferritin levels must be measured throughout the course of treatment. If it is less than 100 ng / ml, iron replacement therapy is recommended. Patients who donate autologous blood and are in the pre- or postoperative period should also receive an additional adequate amount of iron.

During the period of use, the hemoglobin level should be monitored at least once a week until a stable level is reached, then somewhat less frequently. In the pre- and postoperative period, the hemoglobin level should be checked more often if the baseline level was less than 14 g / dL. The hematocrit level should also be monitored regularly. During the first 8 weeks of therapy, the platelet count should be monitored regularly. epoetin alfa can cause a moderate dose-dependent increase in the number of platelets, independently returning to normal during the course of therapy; thrombocytosis is rare.

It should be borne in mind that a preoperative increase in the level of hemoglobin can serve as a predisposing factor for the development of thrombotic complications. Patients should receive adequate prophylactic antithrombotic therapy prior to elective surgery.

In the pre- and postoperative period, it is not recommended to use epoetin alfa with an initial hemoglobin level of more than 15 g / dl.

Use with caution in patients with porphyria. In chronic renal failure during therapy with epoetin alfa, an exacerbation of porphyria is possible.

Correction of anemia may be accompanied by improved appetite and increased absorption of potassium and proteins. It should be borne in mind the possible need for periodic adjustment of dialysis parameters to maintain the level of urea, creatinine and potassium within the normal range. In patients with chronic renal failure, serum electrolyte levels should be monitored.

Patients on hemodialysis, while on epoetin alfa therapy, often require an increase in the dose of heparin during dialysis due to an increase in hematocrit. With an inadequate dose of heparin, occlusion of the dialysis system is possible.

In patients with chronic renal failure and clinically severe coronary artery disease or congestive heart failure, the maintenance hemoglobin level should not exceed the upper limit of the optimal recommended level (no more than 10-12 g / dL in adults).

When used in patients with impaired liver function, it is possible to slow down the biotransformation of epoetin alfa and a pronounced increase in erythropoiesis. The safety of using epoetin alfa in this category of patients has not been established.

The possibility of the influence of epoetin alfa on the growth of certain types of tumors, especially on malignant neoplasms of the bone marrow, cannot be completely ruled out.

All special warnings and precautions associated with the autologous blood collection program should be observed (this applies to all patients receiving epoetin alfa).

The therapeutic efficacy of epoetin alfa may decrease with a deficiency of iron, folic acid, vitamin B12, aluminum intoxication, intercurrent diseases, latent bleeding, hemolysis, and bone marrow fibrosis.

In experimental studies on animals when studying the chronic toxicity of epoetin alfa, in a number of cases, subclinical fibrosis of bone marrow tissues, as well as anemia with signs or without signs of bone marrow hypoplasia, were observed. It is believed that this is due to the emergence of antibodies to epoetin alfa.

No mutagenic effects have been identified.

Influence on the ability to drive vehicles and use mechanisms

When using epoetin alfa until the optimal maintenance dose is established, patients with chronic renal failure should avoid engaging in potentially hazardous activities due to the increased risk of hypertension at the beginning of therapy.

Drug interactions

The effect of epoetin alfa can be enhanced with the simultaneous administration of blood products.

With the simultaneous use of epoetin alfa with cyclosporine, a decrease in the concentration of the latter in plasma is possible due to an increase in the degree of its binding to erythrocytes (when using this combination, it is necessary to control the concentration of cyclosporine in plasma and, if necessary, increase its dose).

Epoetin alfa should not be mixed with solutions of other medicines.