Epocrine, ampoules 10000me, 10pcs

Composition

1 ampoule contains:

Active ingredient:

epoetin alfa (recombinant human erythropoietin),

REPOETIN-SP: 10 000 ME;

excipients:

albumin,

infusion solution 10% in terms of dry albumin 2,500 mg,

sodium citrate pentasequihydrate 5,800 mg or sodium citrate dihydrate 4,776 mg,

sodium chloride 5,840 mg,

citric acid monohydrate 0.057 mg,

water for injection up to 1 ml

Pharmacological action

Epoetin alfa is a glycoprotein that specifically stimulates erythropoiesis and 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 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 erythropoietin 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:

With intravenous use of epoetin alfa in healthy individuals and patients with uremia, the half-life is 5-6 hours. With subcutaneous use of epoetin alfa, its concentration in the blood increases slowly and reaches a maximum in the period from 12 to 18 hours after use, the half-life is 16-24 hours.

Bioavailability of epoetin alfa with subcutaneous use is 25-40%.

Indications

• Anemia in patients with chronic renal failure, including those undergoing hemodialysis.
• Prevention and treatment of anemia in patients with solid tumors, anemia in which was the result of antitumor therapy. Prevention and treatment of anemia in HIV-infected patients (AIDS) caused by the use of zidovudine.
• Prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia.
• Treatment and prevention of anemia in premature children born with a low body weight of up to 1.5 kg.
• To reduce the volume of blood transfused during extensive surgical procedures and acute blood loss.

Contraindications

• Hypersensitivity to the drug or its components Epocrin,
• partial red cell aplasia after previous treatment with any erythropoietin,
• uncontrolled hypertension,
• the impossibility of adequate anticoagulant therapy,
• myocardial infarction within one month after the event,
• unstable angina, or an increased risk of deep vein thrombosis and thromboembolism within predeposit collection programs of the blood before surgery,
• porphyria.

With caution: In patients with a history of thrombosis, malignancies, sickle cell anemia, patients with moderate anemia without iron deficiency, patients with refractory anemia, epilepsy, and chronic liver failure. Since there is no sufficient experience with the use of erythropoietin during pregnancy and lactation in humans, epoetin alfa should be prescribed only if the expected benefits of its use exceed the possible risk to the fetus and mother.

Side effects

In some cases, flu-like symptoms are observed at the beginning of treatment (dizziness, drowsiness, fever, headache, myalgia, arthralgia). Allergic reactions are possible, namely, mild or moderate skin rash, urticaria, pruritus, angioedema, eczema.

On the part of 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 uremia), in some cases a hypertensive crisis, a sharp increase in blood pressure with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic seizures.

On the part of the hematopoietic organs, thrombocytosis may occur, in some cases-thrombosis of shunts (in patients undergoing hemodialysis, especially with a tendency to arterial hypotension or with complications from arteriovenous fistula, for example, stenosis, aneurysm, etc. ).

Local reactions can manifest as hyperemia, burning sensation, mild or moderate pain at the injection site (more often occur with subcutaneous use).

On the part of laboratory parameters, there may be a decrease in the content of ferritin in serum, a decrease in serum parameters of iron metabolism. Patients with uremia may experience hyperkalemia and hyperphosphatemia.

Other side effects may include complications related to respiratory disorders or changes in blood pressure, very rarely immune reactions are possible (induction of antibody formation with or without partial red cell aplasia), exacerbation of porphyria.

Interaction

When epoetin alfa is co-administered with 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 the drug Epocrin to date has not revealed any facts of its pharmacological incompatibility with other drugs.

However, to avoid possible incompatibilities or decreased activity, Epocrine should not be mixed with solutions of other medications.

How to take, course of use and dosage

Treatment of anemia in patients with chronic renal failure:

Epocrine is administered subcutaneously or intravenously. In patients undergoing hemodialysis, the drug is administered through an arteriovenous shunt at the end of the dialysis session.

When changing the method of use, the drug is administered at the same dose, then the dose is adjusted if necessary (with the subcutaneous method of use of the drug Epocrin, a dose of 20-30% less is required to achieve the same therapeutic effect than with intravenous use).

Treatment with Epocrin includes two stages: 1. Stage of correction: With subcutaneous use of the drug Epocrin, the initial single dose is 30 IU / kg 3 times a week. With intravenous use of Epocrin, the initial single 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: :

1) The hematocrit increases from 0.5 to 1.0% per week. In this case, the dose is not changed until optimal values are achieved. 2) The rate of increase in hematocrit is less than 0.5% per week. In this case, it is necessary to increase the single dose by 1.5 times. 3) Growth rate of more than 1.0% per week. In this case, it is necessary to reduce the single dose of the drug by 1.5 times. 4) The hematocrit remains low or decreases. It is necessary to analyze the causes of resistance. The effectiveness of therapy depends on the correct individual treatment regimen.

2. Maintenance therapy stage: 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 the drug is selected individually, taking into account the dynamics of hematocrit and hemoglobin. After stabilization of hemodynamic parameters, it is possible to switch to the use of Epocrin once every 1-2 weeks.

Prevention and treatment of anemia in patients with solid tumors: Before starting treatment, it is recommended to determine the level of endogenous erythropoietin. If the concentration of serum erythropoietin is less than 200 IU / ml, the initial dose of Epocrin is 150 IU/kg with intravenous use. With subcutaneous use, 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 erythropoietin to patients with endogenous serum erythropoietin levels above 200 IU / ml.

Prevention and treatment of anemia in patients with HIV infection: Intravenous use of Epocrine at a dose of 100-150 IU / kg 3 times a week is effective in HIV patients receiving zidovudine therapy, provided that the patient’s serum endogenous erythropoietin level is less than 500 IU / ml, and the dose of zidovudine is less than 4200 mg / week. With subcutaneous use, the dose of Epocrin can be reduced by 1.5 times.

Prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin’s lymphomas, and chronic lymphocytic leukemia: In these patients, the expediency of treatment with epoetin alfa is due to inadequate synthesis of endogenous erythropoietin against the background of anemia development.

If the hemoglobin content is below 100 g / l and serum erythropoietin is below 100 IU / ml, Epocrine is administered subcutaneously at a starting dose of 100 IU/kg three times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly. If necessary, the dose of Epocrine 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, further use of Epocrin should be discontinued as ineffective.

Prevention and treatment of anemia in patients with rheumatoid arthritis: In patients with rheumatoid arthritis, the synthesis of endogenous erythropoietin is suppressed under the influence of an increased concentration of pro-inflammatory cytokines. Treatment of anemia in these patients is carried out with subcutaneous use of the drug Epocrin 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 the drug is increased to 150-200 IU/kg 3 times a week. A further increase in the dose does not seem appropriate.

Treatment and prevention of anemia in premature children born with low body weight: Epocrine is administered subcutaneously at a dose of 200 IU/kg three 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.

Prevention of anemia during extensive surgical interventions and acute blood loss: Epocrine is administered intravenously or subcutaneously three times a week at a dose of 100-150 IU / kg until the hematocrit and hemoglobin content normalize.

Overdose

In case of overdose of the drug Epocrin, effects occur that reflect the extreme degree of its pharmacological action.

In case of increased blood pressure, antihypertensive agents are prescribed, if it is impossible to reduce blood pressure with antihypertensive agents, therapy with Epocrin should be discontinued.

With high hemoglobin and hematocrit, bloodletting is indicated.

Special instructions

During treatment, it is necessary to monitor blood pressure weekly and perform 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, Hb should be monitored more frequently if its baseline level is less than 140 g/l. It should be remembered 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.

If a hypertensive crisis develops, urgent measures are taken to provide medical care to the patient, and treatment with epoetin alfa should be interrupted. When appointing epoetin alfa to patients with hepatic insufficiency, its metabolism may slow down and a pronounced increase in erythropoiesis may occur. The safety of epoetin alfa in this group of patients has not been established. It is also impossible to exclude the possibility of the effect of epoetin alfa on the growth of certain types of tumors, including bone marrow tumors. One should consider the possibility that preoperative Hb elevation 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 deficiency, folic acid, cyanocobalomine, severe aluminum salt poisoning, concomitant infections, inflammatory processes and injuries, hidden 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 content of ferritin in the blood serum decreases simultaneously with an increase in hematocrit. Serum ferritin levels should be monitored throughout the course of treatment. If it is less than 100 ng/ml, iron therapy is recommended at the rate of 200-300 mg / day (for children,100-200 mg / day). Preterm children should be treated with 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.

When using epoetin alfa in women of reproductive age with anemia on the background of chronic renal failure, it is possible to resume menstruation as hemoglobin normalizes. The patient should be warned about the possibility of pregnancy and the need for reliable methods of contraception before starting therapy.

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 and speed of psychomotor reactions, due to the increased risk of high blood pressure at the beginning of therapy.

Taking into account the possible more pronounced effect of the drug Epocrin, its dose should not exceed the dose of recombinant erythropoietin used in the previous course of treatment. During the first two weeks, the dose is not changed, the dose/response ratio is evaluated. After that, the dose can be reduced or increased according to the above scheme.

Form of production

Solution for intravenous and subcutaneous use

Storage conditions

At a temperature of 2 to 8 °C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Epoetin alfa

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Purpose

For adults as directed by your doctor

Indications

Anemia