Eralfon,. 2000 me 0.5 ml syringe 6 pcs.

Recombinant human erythropoietin, a purified glycoprotein. It stimulates erythropoiesis. It is synthesized in mammalian cells that have the gene encoding human erythropoietin.

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 undergoing hemodialysis.

Treatment of anemia in cancer patients (with or without chemotherapy) for non-myeloid tumors.

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

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

As part of a predeposit program before major 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 (when the expected need for transfusion is higher than the amount that can be obtained without the use of epoetin alfa).

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

Pharmacological effect

Recombinant human erythropoietin is a purified glycoprotein. Stimulates erythropoiesis. It is synthesized in mammalian cells into which the gene encoding human erythropoietin is embedded.

Special instructions

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

Use with caution for gout.

Before use, ensure that patients with arterial hypertension have received effective antihypertensive therapy.

During use, it is necessary to monitor blood pressure levels, paying attention to the occurrence or worsening of unusual headaches. This may require adjustment of therapy or prescription of antihypertensive drugs. If blood pressure does not decrease despite adequate therapy, 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 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 additional adequate amounts of iron.

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

It should be taken into account that a preoperative increase in hemoglobin levels may serve as a predisposing factor to the development of thrombotic complications. Patients should receive adequate prophylactic antithrombotic therapy before undergoing elective surgery.

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

Use with caution in patients with porphyria. In case of 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 that it may be necessary to periodically adjust dialysis parameters to maintain levels of urea, creatinine and potassium within normal limits. In patients with chronic renal failure, it is necessary to monitor the level of electrolytes in the blood serum.

Hemodialysis patients treated with epoetin alfa often require increased heparin dosage during dialysis due to increased hematocrit. With an inadequate dose of heparin, occlusion of the dialysis system is possible.

In patients with chronic renal failure and clinically significant coronary artery disease or congestive heart failure, maintenance hemoglobin levels 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, the biotransformation of epoetin alfa may be slowed down and erythropoiesis may be significantly increased. The safety of epoetin alfa in this category of patients has not been established.

The possibility that epoetin alfa may influence the growth of certain types of tumors, especially bone marrow malignancies, cannot be completely excluded.

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 effectiveness of epoetin alfa may be reduced by deficiency of iron, folic acid, vitamin B12, aluminum intoxication, intercurrent diseases, hidden bleeding, hemolysis, bone marrow fibrosis.

In experimental animal studies examining the chronic toxicity of epoetin alfa, subclinical fibrosis of bone marrow tissue, as well as anemia with or without signs of bone marrow hypoplasia, were observed in some cases. This is believed to be due to the appearance of antibodies to epoetin alfa.

No mutagenic effect was detected.

Impact on the ability to drive vehicles and operate machinery

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 an increased risk of developing arterial hypertension at the beginning of therapy.

Active ingredient

Epoetin alfa

Composition

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

1 syringe
epoetin alfa (human erythropoietin recombinant)
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.

Contraindications

Uncontrolled arterial hypertension, increased sensitivity to epoetin alfa.

Before performing a major surgical operation not within the framework of a pre-deposit program, using autologous blood is contraindicated in cases of severe vascular pathology (including coronary, carotid, cerebral, peripheral) and in cases of recent myocardial infarction or acute cerebrovascular accident.

Side Effects

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

From the cardiovascular system: a dose-dependent increase in blood pressure is possible; worsening 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 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 concentrations 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 pain at the injection site (more often occurs with subcutaneous administration).

Other: rarely – potentially serious complications associated with respiratory failure or decreased blood pressure; immune reactions (has minimal ability to induce the formation of antibodies).

Interaction

The effect of epoetin alfa may be enhanced by concomitant administration of blood products.

With 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 drugs.

Manufacturer

PharmFirma Sotex, Russia