Epocrine, ampoules 2000 me, 10 pcs.

Composition

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1 ml of the solution contains:

Active ingredients:

epoetin alfa (recombinant human erythropoietin) 2000 IU.

Auxiliary substances:

albumin (in the form of albumin,10% infusion solution) – 2.5 mg,

sodium citrate pentasesquihydrate-5.8 mg or sodium citrate dihydrate-4.776 mg,

sodium chloride-5.84 mg,

citric acid monohydrate-0.057 mg,

water for d / i-up to 1 ml.

In an ampoule 1 ml of the solution.

In a contour cell pack of 10 ampoules.

There is 1 contour cell package in a cardboard box.

Pharmacological action

Pharmacodynamics

Stimulator of erythropoiesis, recombinant human erythropoietin, glycoprotein.

Activates mitosis and maturation of red blood cells from erythrocyte progenitor cells. Recombinant Epoetin alfa is synthesized in mammalian cells that contain the gene encoding human erythropoietin. By its composition, biological and immunological properties, Epoetin alfa is identical to natural human erythropoietin. The introduction of epoetin alfa leads to an increase in the level of hemoglobin and hematocrit, an improvement in blood supply to tissues and heart function.

The most pronounced effect of the use of epoetin alfa is observed in anemia caused by chronic renal failure.

In very rare cases, with prolonged use of epoetin alfa for the treatment of anemic conditions, the formation of neutralizing antibodies to erythropoietin may occur with or without the development of partial red cell aplasia.

Pharmacokinetics

Suction and distribution

After subcutaneous administration, the concentration of the Active ingredient in the blood increases slowly, _Cmax is reached within 12-18 hours. Bioavailability with subcutaneous administration is 25-40%.

Deduction

After subcutaneous administration, T_1/2 is 16-24 hours.

After intravenous administration, T_1/2 in healthy individuals and patients with uremia is 5-6 hours.

Indications

• Anemia in patients with chronic renal failure (including hemodialysis);
• prevention and treatment of anemia in patients with solid tumors caused by antitumor therapy;
• prevention and treatment of anemia caused by the use of zidovudine in HIV-infected patients (AIDS);
• prevention and treatment of anemia in patients with multiple myeloma, non-Hodgkin’s lymphoma, low-grade, chronic lymphocytic leukemia, patients with rheumatoid arthritis;
• prevention and treatment of anemia in premature children born with low body weight (1500 g);
• to reduce the volume of transfused blood in extensive surgical intervention and acute blood loss.

Use during pregnancy and lactation

Since experience with the use of epoetin alfa during pregnancy and lactation in humans is insufficient, Epocrin® should be prescribed only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus or infant.

When using epoetin alfa in women of reproductive age with anemia on the background of chronic renal failure, it is possible to resume menstruation.

The patient should be warned about the possibility of pregnancy and the need for reliable methods of contraception before starting therapy.

Contraindications

• Partial red cell aplasia after previous therapy with any erythropoietin;
• uncontrolled arterial hypertension;
• inability to conduct adequate anticoagulant therapy;
• period within 1 month after a myocardial infarction;
• unstable angina;
• increased risk of deep vein thrombosis and thromboembolism in the pre-deposit blood collection program before surgery;
• porphyria;
• hypersensitivity to the components of the drug.

With caution: the drug should be prescribed to patients with a history of thrombosis, malignancies, sickle cell anemia, in patients with moderate anemia without iron deficiency, in patients with refractory anemia, epilepsy and chronic liver failure.

Side effects

Flu-like syndrome: in some cases, at the beginning of therapy – dizziness, drowsiness, fever, headache, myalgia, arthralgia.

From the cardiovascular system: possible dose-dependent arterial hypertension, worsening of the course of arterial hypertension (more often in patients with uremia); in some cases – hypertensive crisis, a sharp increase in blood pressure with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic seizures.

From the side of metabolism: a decrease in the concentration of ferritin in serum, a decrease in serum parameters of iron metabolism; in patients with uremia, hyperkalemia and hyperphosphatemia are possible.

Allergic reactions: possible-mild or moderate skin rash, urticaria, pruritus, angioedema, eczema.

Local reactions: hyperemia, burning sensation, mild or moderate pain at the injection site are possible (more often occur with subcutaneous administration).

Other: thrombocytosis; in some cases – shunt thrombosis (in patients on hemodialysis, with a tendency to hypotension or with aneurysm, stenosis); symptoms associated with respiratory disorders or unstable blood pressure; very rarely-immune reactions (induction of antibody formation with or without partial red cell aplasia), exacerbation of porphyria.

Interaction

Concomitant use of Epocrin® with cyclosporine increases the binding of the latter to red blood cells (dose adjustment of cyclosporine may be required).

Based on the current experience of clinical use of the drug Epocrin®, no facts of its pharmacological incompatibility with other drugs have been revealed. However, to avoid possible incompatibilities or decreased activity, Epocrine® should not be mixed with solutions of other medicinal products.

How to take, course of administration and dosage

In the treatment of anemia in patients with chronic renal failure, Epocrin® is administered subcutaneously or IV; in patients on hemodialysis, through an arteriovenous shunt at the end of the dialysis session. If the method of administration is changed, the drug is administered at the same dose, then the dose is adjusted if necessary (with subcutaneous administration of Epocrin®, a dose of 20-30% less is required to achieve the same therapeutic effect than with intravenous administration). Treatment with Epocrin includes 2 stages.

1. Correction stage. With subcutaneous administration of Epocrin®, the initial dose is 30 IU / kg 3 times a week. With intravenous administration of Epocrin®, the initial dose is 50 IU/kg. The correction period lasts until the optimal level of hemoglobin (100-120 g/l in adults and 95-110 g/l in children) and hematocrit (30-35%) is reached. These indicators should be monitored weekly.

The following situations are possible::

The effectiveness of therapy depends on the correct individual treatment regimen.

2. Stage of maintenance therapy. To maintain the hematocrit at the level of 30-35%, the dose of Epocrin® used at the correction stage should be reduced by 1.5 times. Then the maintenance dose of Epocrin® is selected individually, taking into account the dynamics of hematocrit and hemoglobin. After stabilization of hematological parameters, it is possible to switch to the administration of Epocrin® 1 time in 1-2 weeks.

In the prevention and treatment of anemia in patients with solid tumors, it is recommended to determine the level of endogenous erythropoietin before using the drug. If the serum erythropoietin concentration is less than 200 IU / ml, the initial dose of Epocrin® for intravenous administration is 150 IU / kg. With subcutaneous administration, the initial dose of Epocrin® can be reduced to 100 IU/kg. If there is no response, the dose may be increased to 300 IU/kg. A further increase in the dose seems impractical. It is not recommended to prescribe Epocrin® to patients with an endogenous serum erythropoietin content of more than 200 IU / ml.

For the prevention and treatment of anemia caused by the use of zidovudine in patients with HIV infection, intravenous administration of Epocrin® at a dose of 100-150 IU / kg 3 times a week is effective, provided that the level of serum endogenous erythropoietin is less than 500 IU / ml, and the dose of zidovudine is less than 4.2 g per week. With subcutaneous administration, the dose of Epocrin® can be reduced by 1.5 times.

The expediency of using Epocrin® for the prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin’s lymphomas, and chronic lymphocytic leukemia is due to inadequate synthesis of endogenous erythropoietin against the background of anemia development. If the hemoglobin content is less than 100 g / l and serum erythropoietin is below 100 IU / ml, Epocrin® is administered subcutaneously at an initial dose of 100 IU/kg 3 times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly.If necessary, the dose of Epocrin® is adjusted to increase or decrease every 3-4 weeks. If no increase in hemoglobin is observed after reaching the weekly dose of 600 IU/kg, Epocrin® should be discontinued, since its further use is ineffective.

The expediency of using Epocrin® for the prevention and treatment of anemia in patients with rheumatoid arthritis is due to the fact that in this disease there is a suppression of the synthesis of endogenous erythropoietin under the influence of an increased concentration of pro-inflammatory cytokines. Epocrin® is administered subcutaneously at a dose of 50-75 IU/kg 3 times a week. If the hemoglobin content increases by less than 10 g/l after 4 weeks of treatment, the dose of Epocrin® is increased to 150-200 IU/kg 3 times a week. A further increase in the dose does not seem appropriate.

For the prevention and treatment of anemia in premature children born with low body weight, Epocrin® is administered subcutaneously at a dose of 200 IU / kg 3 times a week, starting from the 6th day of life until the target hemoglobin and hematocrit indicators are reached, but no more than 6 weeks.

To prevent anemia during extensive surgical interventions and acute blood loss, Epocrin® is administered intravenously or subcutaneously 3 times a week at a dose of 100-150 IU / kg until the hematocrit and hemoglobin content normalize.

Overdose

Symptoms: possible increased side effects.

Treatment: in case of increased blood pressure, antihypertensive agents are prescribed, if the latter are ineffective, Epocrin® should be discontinued.

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

Special instructions

Keep in mind the possibility of increasing blood pressure at the beginning of therapy. Given the possible more pronounced effect of Epocrin®, its dose should not exceed the dose of recombinant erythropoietin, which was used in the previous course of treatment. During the first two weeks, the dose is not changed, assessing the dose/response ratio. After that, the dose can be reduced or increased according to the above scheme.

During treatment, it is necessary to monitor blood pressure weekly, conduct a general blood test, including determination of hematocrit, platelets and ferritin. In patients with uremia who are on hemodialysis, due to an increase in hematocrit, it is often necessary to increase the dose of heparin, in addition, timely prevention of thrombosis and early revision of the shunt are necessary.

In the pre – and postoperative period, hemoglobin should be monitored more frequently if its initial level was less than 140 g / l.

It should be borne in mind that epoetin alfa does not replace blood transfusion, but reduces the volume and frequency of its use. In patients with controlled arterial hypertension or with thrombotic complications, an increase in the dose of antihypertensive and/or anticoagulant medications may be required. With the development of a hypertensive crisis, emergency therapy is carried out, treatment with epoetin alfa in such cases should be temporarily discontinued.

When prescribing Epocrin® to patients with hepatic insufficiency, it is possible to slow down its metabolism and significantly increase erythropoiesis. The safety of using epoetin alfa in this category of patients has not been established.

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

It is necessary to consider the possibility that a preoperative increase in hemoglobin levels may serve as a predisposing factor to the development of thrombotic complications. Before starting treatment, possible causes of an inadequate response to the drug (iron, folic acid, cyanocobalamin deficiency, severe aluminum ion poisoning, concomitant infections, inflammatory processes and injuries, latent blood loss, hemolysis, bone marrow fibrosis of various etiologies) should be excluded and, if necessary, treatment should be adjusted.

In most patients with uremia, cancer, and HIV-infected patients, the level of ferritin in 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, oral iron replacement therapy is recommended at the rate of 200-300 mg / day (for children-100-200 mg / day). Preterm children should receive oral iron supplements at a dose of 2 mg/day as early as possible. Patients who donate autologous blood and are in the pre-or postoperative period should also receive adequate iron therapy at a dose of up to 200 mg / day.

In patients with uremia, correction of anemia with epoetin alfa can lead to an improvement in appetite and an increase in the absorption of potassium and proteins. In this regard, it may be necessary to periodically adjust the parameters of hemodialysis to maintain the level of urea, creatinine and potassium in the normal range. In these patients, it is also necessary to monitor the level of electrolytes in the blood serum.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

During the treatment period, until the optimal maintenance dose is established, patients with uremia should avoid engaging in potentially dangerous activities that require increased concentration of attention and high speed of psychomotor reactions.

Form of production

Solution for intravenous and subcutaneous administration

Storage conditions

At a temperature of 2-8 °C

Shelf life

2 years

Active ingredient

Epoetin alfa

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Weight

Weight: 48 gr.