Eralfon solution 2000IU 0.5ml syringe, 6pcs

Composition

The solution for intravenous and subcutaneous use is clear, colorless.

Auxiliary substances:

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,

d/i water-up to 0.5 ml

Pharmacological action

Recombinant human erythropoietin is a purified glycoprotein. It stimulates erythropoiesis. It is synthesized in mammalian cells, in which the gene encoding human erythropoietin is embedded. According to its biological and immunological properties, it is identical to human erythropoietin isolated from urine. The synthesis of endogenous erythropoietin is carried out in the kidneys and depends on the level of blood oxygenation. Pharmacokineticsafter subcutaneous use, the concentration of the Active ingredient in plasma increases slowly, reaching a maximum level after 12-18 hours. After repeated intravenous use, T1 / 2 in healthy adults is 4 hours, in patients with renal insufficiency – about 6 hours; in children – about 6 hours.

Indications

Treatment of anemia associated with chronic renal failure in adult patients undergoing hemo-or peritoneal dialysis, or who are indicated for dialysis; in children undergoing hemodialysis.

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

Prevention of anemia in cancer patients with non-myeloid tumors receiving a long course of chemotherapy.

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

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

Before performing an extensive operation with an 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.

Contraindications

Uncontrolled arterial hypertension, hypersensitivity to epoetin alfa.

It is contraindicated in cases of severe vascular pathology (including coronary, carotid, cerebral, peripheral) and in cases of recent myocardial infarction or acute cerebrovascular accident before performing an extensive surgical operation that is not part of a pre-deposit program using autologous blood.

Side effects

Flu-like syndrome:  possible dizziness, drowsiness, fever, headache, joint and muscle pain (mainly at the beginning of treatment).

From the cardiovascular system:  there may be a dose-dependent increase in blood pressure; 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.

From the side 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, increased concentration of urea, creatinine, uric acids in blood plasma (in patients with chronic renal failure).

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

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

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

Interaction

The effect of epoetin alfa may be enhanced by simultaneous use of blood products.

When epoetin alfa is co-administered with cyclosporine, it is possible to reduce the concentration of the latter in plasma due to an increase in the degree of its binding to red blood cells (when using this combination, it is necessary to monitor the concentration of cyclosporine in plasma and, if necessary, increase its dose).

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

How to take, course of use and dosage

Enter subcutaneous or intravenous injection. A single dose of 30-100 U / kg, the frequency of use and duration of use are set individually.

Special instructions

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

Use with caution for gout.

Before starting treatment, make sure that patients with arterial hypertension have received effective antihypertensive therapy.

During the application, it is necessary to monitor the level of blood pressure, paying attention to the occurrence or increase of unusual headaches. In this case, it may be necessary to adjust the therapy or prescribe antihypertensive agents. 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 evaluated. In most patients with chronic renal failure, cancer and HIV-infected patients, the level of ferritin in blood plasma decreases simultaneously with an increase in hematocrit. Ferritin levels should be determined 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 application period, the hemoglobin level should be monitored at least once a week until a stable level is reached, then somewhat less often. In the pre – and postoperative period, the hemoglobin level should be checked more often if the initial 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, as epoetin alfa can cause a moderate dose-dependent increase in platelet count, which independently returns to normal during the course of therapy; thrombocytosis rarely develops.

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

In the pre – and postoperative period, it is not recommended to use epoetin alfa if the initial hemoglobin level exceeds 15 g / dl.

Use with caution in patients with porphyria. In case of chronic renal failure, treatment with epoetin alfa may lead to an exacerbation of porphyria.

Correction of anemia can be accompanied by an improvement in appetite and an increase in the absorption of potassium and proteins. Keep in mind the possible need for periodic correction of dialysis parameters to maintain the level of urea, creatinine and potassium in the normal range. In patients with chronic renal failure, it is necessary to monitor the level of electrolytes in the blood serum.

Patients on hemodialysis receiving 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 significant CHD 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.

It is impossible to completely exclude the possibility of the effect of epoetin alfa on the growth of certain types of tumors, especially on malignant neoplasms of the bone marrow.

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

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

In experimental animal studies of the chronic toxicity of epoetin alfa, subclinical fibrosis of bone marrow tissues and anemia with or without signs of bone marrow hypoplasia were observed in some cases. It is believed that this is due to the appearance of antibodies to epoetin alfa.

No mutagenic effects were detected.

Influence on the ability to drive motor vehicles and manage mechanisms

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

Active ingredient

Epoetin alfa

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Anemia