Erythropoietin solution 2000 IU/ml ampoules 1 ml 10 pcs.

Composition

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1 ml of the solution contains:

Active ingredient:

Recombinant human erythropoietin 500IU or 2000 ME.

Indications

Treatment of anemia of renal origin in patients with chronic renal failure, including those on dialysis.

Prevention and treatment of anemia in adult patients with solid tumors receiving chemotherapy with platinum preparations that can cause anemia (carboplatin 75 mg / m2 per cycle, carboplatin 350 mg / m2 per cycle).

Treatment of anemia in adult patients with myeloma, low-grade non-Hodgkin’s lymphoma and chronic lymphocytic leukemia receiving antitumor therapy, with a relative lack of endogenous erythropoietin (it is defined as the concentration of erythropoietin in serum, disproportionately low relative to the degree of anemia).

Increase in the volume of donated blood intended for subsequent autotransfusion. At the same time, the benefits of using epoetin beta should be correlated with an increased risk of thromboembolism when using it. Patients with moderate anemia (hemoglobin level 100-130 g / l or hematocrit 30-39%, without iron deficiency) are prescribed the drug only if it is not possible to obtain a sufficient amount of preserved blood, and planned major surgical intervention may require a large volume of blood (>4 units for women or >5 units for men).

Prevention of anemia in premature newborns born with a body weight of 750-1500 g, up to 34 weeks of pregnancy.

Contraindications

Hypersensitivity to the drug or its components, partial red cell aplasia after previous therapy with any epoetin beta, uncontrolled arterial hypertension, inability to conduct adequate anticoagulant therapy, myocardial infarction within a month after the event, unstable angina or an increased risk of deep vein thrombosis and thromboembolism as part of a pre-deposit blood collection program before surgery, porphyria.

Side effects

Adverse reactions are listed according to the following gradation: common (>1%,0,1%,0,01%, >

From the cardiovascular system: in patients with anemia and chronic renal failure, an increase in blood pressure (BP) or an increase in pre – existing arterial hypertension is most common, especially in the case of a rapid increase in hematocrit. In this case, it is recommended to prescribe medication for antihypertensive therapy, if there is no effect, it is recommended to temporarily interrupt therapy with epoetin beta.

In some patients (including those with previously normal or low blood pressure) – hypertensive crisis with encephalopathy phenomena (headaches, confusion, sensory and motor disorders – speech disorders, gait disorders, up to tonic-clonic convulsions) that require urgent medical care and intensive care. Special attention should be paid to sudden migraine-like pain.

Patients with solid tumors, myeloma, non-Hodgkin’s lymphomas, or chronic lymphocytic leukemia may rarely experience headaches and increased blood pressure, which can be stopped by the use of drugs.

From the side of hematopoietic organs: in patients with renal insufficiency and anemia, a dose-dependent increase in platelet count may occur (which does not go beyond the normal range and disappears with continued therapy), especially after intravenous administration. Very rarely, thrombocytosis develops. Due to increased hematocrit, it is often necessary to increase the dose of heparin during hemodialysis. With inadequate heparinization, blockage of the dialysis system is possible. Shunt thrombosis may develop, especially in patients with a tendency to hypotension or with complications of arteriovenous fistula (for example, stenosis, aneurysm, etc. ). In such situations, early revision of the shunt and timely prevention of thrombosis (acetylsalicylic acid) are recommended.

In most cases, simultaneously with an increase in hematocrit, the content of ferritin in serum decreases. In some cases, patients with uremia have increased serum potassium and phosphate levels.

Some patients with solid tumors, myeloma, non-Hodgkin’s lymphomas, or chronic lymphocytic leukemia show a decrease in serum iron metabolism. Clinical studies have shown that the incidence of thromboembolism in cancer patients treated with Erythropoietin is slightly higher than in the absence of such therapy or with placebo; however, a clear causal relationship with the drug has not been established.

In premature newborns, in most cases, there is a decrease in serum ferritin, and there may be a slight increase in the number of platelets, especially on the 12-14 day of life.

Patients preparing for blood donation for subsequent autotransfusion and receiving epoetin beta have an increase in the number of platelets, usually not exceeding the normal range, and a higher frequency of thromboembolic complications, although their causal relationship with the use of the drug has not been established.

Other services: rarely – allergic skin reactions in the form of rash, pruritus, urticaria, or injection site reactions. Individual cases of anaphylactoid reactions are described. However, in controlled clinical trials, the frequency of hypersensitivity reactions did not increase.

In some cases, especially at the beginning of therapy, flu-like symptoms were noted, such as fever, chills, headache, pain in the limbs and bones, malaise.

These reactions were mild or moderate and disappeared within a few hours or days.

Interaction

With simultaneous use of Erythropoietin and cyclosporine, it may be necessary to adjust the dose of the latter due to an increase in its binding to red blood cells.

The experience of clinical use of Erythropoietin to date has not revealed any facts of its pharmacological incompatibility with other drugs.

However, to avoid possible incompatibilities or reduced activity.

Erythropoietin should not be mixed with solutions of other medications

How to take, course of administration and dosage

The dose, schedule and duration of treatment are set individually, depending on the severity of anemia, the severity of the patient’s condition, and the nature of the disease.

Enter subcutaneous injection and intravenous injection.

Initial doses are 50-150 IU / kg, the frequency of administration is on average 3 times a week.

Overdose

Symptoms: hypertension, erythrocytosis, hyperhemoglobinemia, a sharp increase

in the hematocrit.

Treatment: symptomatic. In the case of hypertension, it is necessary to exclude excessive hydration. In the presence of erythrocytosis and hyperhydration, measures are needed to remove excess fluid.

With a high level of hemoglobin and hematocrit, phlebotomy is indicated.

Active ingredient

Epoetin beta

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Description

Adults as prescribed by a doctor

Indications

From anemia

Weight

Weight: 41 gr.