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

Anemia

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.

The treatment of anemia in cancer patients (receiving or not receiving chemotherapy) with nonmyeloid tumors.

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

The treatment of anemia in HIV patients receiving zidovudine therapy (when endogenous erythropoietin levels ≤ 500 IU/mL).

In a preoperative program before major surgery in patients with hematocrit levels of 33-39%, to facilitate the collection of autologous blood and to reduce the risks associated with the use of allogeneic hemotransfusions (when the expected need for transfused blood is higher than the amount that can be obtained without the use of epoetin alfa).

Before 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 hemotransfusions and improve erythropoiesis recovery.

Active ingredient

Epoetin alfa

Composition

The solution for intravenous and p/n injection is clear, colorless.

Associates:

Sodium chloride – 2.92 mg,

Sodium citrate pentasquihydrate – 2.9 mg or sodium citrate dihydrate – 2.

Albumin solution (in terms of dry albumin) – 1.25 mg,

citric acid monohydrate – 0.0285 mg,

d/i water – up to 0.5 ml.

How to take, the dosage

It is administered by injection or intravenously. A single dose of 30-100 units/kg, number of injections and duration of use are determined individually.

Interaction

The action of epoetin alfa may be enhanced with concomitant administration of blood products.

In concomitant use of epoetin alfa with cyclosporine, plasma concentrations of the latter may decrease due to increased binding to red blood cells (when using this combination it is necessary to monitor the concentration of cyclosporine in plasma and increase its dose, if necessary).

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

Special Instructions

With caution, use in patients with a history of seizure reactions; patients at increased risk of thrombosis or other vascular complications require close medical monitoring.

With caution, use with gout.

Be sure that patients with arterial hypertension have received effective antihypertensive therapy before initiating use.

At the time of use, BP should be monitored, paying attention to the occurrence or worsening of unusual headaches. In this case it may be necessary to correct the current therapy or to prescribe antihypertensive agents. If BP does not decrease despite adequate therapy, epoetin alfa should be discontinued.

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

Hemoglobin levels should be monitored at least once a week during administration until stable levels are achieved, then somewhat less frequently. In the pre- and postoperative period, hemoglobin levels should be checked more frequently if baseline levels were less than 14 g/dL. Hematocrit levels should also be monitored regularly. During the first 8 weeks of therapy, platelet counts should be monitored regularly, since epoetin alfa may cause a moderate dose-dependent increase in platelet counts, which self-adjust to normal during the course of therapy; thrombocytosis rarely develops.

It should be considered that preoperative elevation of hemoglobin levels may be a predisposing factor for the development of thrombotic complications. Patients should receive adequate prophylactic antithrombotic therapy prior to elective surgery.

The use of epoetin alfa at baseline hemoglobin levels greater than 15 g/dL is not recommended in the pre- and postoperative period.

With caution, use in patients with porphyria. In chronic renal insufficiency during therapy with epoetin alfa worsening of porphyria is possible.

The correction of anemia may be accompanied with the improvement of appetite and increase of potassium and protein absorption. It should be borne in mind that periodic correction of dialysis parameters may be necessary to maintain urea, creatinine and potassium levels within normal limits. In patients with chronic renal insufficiency, serum electrolyte levels should be monitored.

Patients on hemodialysis during therapy with epoetin alfa often need an increased dose of heparin during dialysis due to increased hematocrit. In case of inadequate dose of heparin, dialysis system occlusion is possible.

In patients with chronic renal failure and clinically significant CHD 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 liver dysfunction there may be delayed biotransformation of epoetin alfa and marked enhancement of erythropoiesis. Safety of epoetin alfa use in this category of patients has not been established.

Possible effect of epoetin alfa on growth of some types of tumors, especially bone marrow malignancies, cannot be completely excluded.

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

Therapeutic efficacy of epoetin alfa may decrease with deficiency of iron, folic acid, vitamin B₁₂, aluminum intoxication, intercurrent illness, hidden bleeding, hemolysis, bone marrow fibrosis.

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

No mutagenic effects have been identified.

Impact on ability to drive and operate machinery

When using epoetin alfa until the optimal maintenance dose is established, patients with CKD should avoid potentially hazardous activities because of the increased risk of arterial hypertension at the beginning of therapy.

Contraindications

Uncontrolled arterial hypertension, hypersensitivity to epoetin alfa.

Pending major non-prednisional surgery with autologous blood is contraindicated if there is severe vascular disease (including coronary, carotid, cerebral, peripheral) and recent myocardial infarction or acute cerebral arrhythmias.

Side effects

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

Cardiovascular system disorders: dose-dependent increase of BP; worsening of arterial hypertension course is possible (most frequently in patients with chronic renal insufficiency); in single cases – hypertensive crises, malignant arterial hypertension with encephalopathy symptoms (headache, mental confusion) and generalized tonic-clonic convulsions.

Hematopoietic system disorders: rare – thrombocytosis.

coagulation system disorders: in single cases – thrombosis of shunt (in patients on hemodialysis with a tendency to hypotension or in the presence of stenoses, aneurysms).

Ureinary system disorders: hyperkalemia, hyperphosphatemia, increased concentration of urea, creatinine, uric acid in plasma (in patients with chronic renal failure) are possible.

Allergic reactions: in some cases – mild to moderately expressed skin rash, eczema, urticaria, pruritus, angioedema.

Local reactions: redness, burning sensation, mild to moderate pain at the site of injection may occur (more often if administered by injection).

Others: rare – potentially serious complications related to respiratory distress or a decrease in BP; immune reactions (has minimal ability to induce antibody formation).

Similarities

Binocrit