EPOCRIN AMPOULE 10000ME

Release form

Solution for intravenous and subcutaneous administration

Pharmacology

Epocrin - erythropoiesis stimulator, human recombinant erythropoietin, glycoprotein.
Activates mitosis and maturation of erythrocytes from erythrocyte progenitor cells. Recombinant epoetin alpha is synthesized in mammalian cells into which the gene encoding human erythropoietin is inserted. According to its composition, biological and immunological properties of epoetin alfa is identical to natural human erythropoietin. The introduction of epoetin alfa leads to an increase in hemoglobin and hematocrit, an improvement in the blood supply to the tissues and the functioning of the heart.
The most pronounced effect of the use of epoetin alfa is observed with anemia caused by chronic renal failure.
In very rare cases, with long-term use of epoetin alfa for the treatment of anemic conditions, the formation of neutralizing antibodies to erythropoietin can be observed with the development of partial red cell aplasia or without it.

Indications

- anemia in patients with chronic renal failure (including those on hemodialysis);
- prevention and treatment of anemia in patients with solid tumors resulting from antitumor therapy;
- prevention and treatment of anemia caused by zidovudine use in HIV-infected patients (AIDS);
- prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin's lymphomas, chronic lymphatic leukemia, in patients with rheumatoid arthritis;
- prevention and treatment of anemia in premature babies born with low birth weight (up to 1500 g);
- to reduce the volume of transfused blood during extensive surgical interventions and acute blood loss.

Contraindications

- partial red cell aplasia after previous treatment with any erythropoietin;
- uncontrolled arterial hypertension;
- the inability to conduct adequate anticoagulant therapy;
- a period within 1 month after a myocardial infarction;
- unstable angina;
- increased risk of deep vein thrombosis and thromboembolism in the framework of the pre-deposit program of blood collection before surgery;
- porphyria;
- Hypersensitivity to the components of the drug Epocrin.
Carefully It should be prescribed to patients with thrombosis (in history), with malignant neoplasms, with sickle cell anemia, in patients with moderate anemia without iron deficiency, in patients with refractory anemia, epilepsy and chronic hepatic insufficiency.

Pregnanacy and breastfeeding

Since the experience of using 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 outweighs the potential risk to the fetus or infant.

Dosage and administration

Anemia in patients with chronic kidney disease:the initial dose of Epocrin 30-75 IU / kg 3 times a week. The correction period lasts until the optimal level of hemoglobin (110-125 g / l) and hematocrit (30-35%) is reached. These indicators need to be monitored weekly. The following situations are possible:

1. Hematocrit rises from 0.5 to 2.0% per week. In this case, the dose does not change until the optimum performance.
2. Reduced response to EPO - hematocrit increase rate less than 0.5% per week. A single dose increase of 25 IU / kg is required. The maximum dose is 300 IU / kg three times a week.
3. Increased response to EPO - hematocrit increase rate over 2.0% in two weeks. It is necessary to reduce a single dose of the drug by 1.5 times.
4. Hematocrit remains low or decreases. It is necessary to analyze the causes of resistance.

The effectiveness of therapy depends on the correctly selected individual treatment regimen.

Adverse effects

In some cases, at the beginning of therapy is notedflu-like syndrome: dizziness, drowsiness, fever, headache, myalgia, arthralgia.
Cardiovascular: 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.
Metabolism:possible reduction of serum ferritin concentration; in patients with uremia, hyperkalemia and hyperphosphatemia are possible.
Local reactions: possible hyperemia, burning, weak or moderate pain at the injection site (often occur when s / to the introduction).
Allergic reactions: mild to moderate skin rash, urticaria, pruritus, angioedema, eczema.
Other: thrombocytosis; in some cases - shunt thrombosis (in patients on hemodialysis, with a tendency to arterial hypotension or with aneurysm, stenosis); symptoms associated with impaired breathing or unstable blood pressure; immune reactions (induction of antibody formation with the development of partial red-cell aplasia or without it), exacerbation of porphyria.

Special notes

When using epoetin alfa in women of postreproductive age, it is possible to resume menstruation. The patient should be warned about the possibility of pregnancy and the need to use reliable methods of contraception before starting therapy.
During treatment, it is necessary to monitor blood pressure weekly, complete blood count, including the 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 controlled more often if its initial level was less than 140 g / l.
It must 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 drugs may be required. With the development of hypertensive crisis, emergency treatment is carried out, treatment with epoetin alfa in such cases should be temporarily canceled.
When prescribing Epocrin in patients with hepatic insufficiency, it is possible to slow down its metabolism and significantly increase erythropoiesis. The safety of epoetin alfa in this category of patients has not been established.
It is impossible to exclude the possibility of the influence of epoetin alfa on the growth of certain types of tumors, including bone marrow tumors.
The possibility that a preoperative hemoglobin level increase may be a predisposing factor to the development of thrombotic complications should be taken into account. Before starting treatment, possible causes of an inadequate reaction to the drug (iron deficiency, folic acid, cyanocobalamin, severe poisoning with aluminum ions,concomitant infections, inflammatory processes and injuries, hidden blood loss, hemolysis, bone marrow fibrosis of various etiologies) and, if necessary, adjust the treatment.
Most patients with uremia, cancer and HIV-infected plasma ferritin levels decrease simultaneously with an increase in hematocrit. The level of ferritin must be determined during the entire course of treatment. If it is less than 100 ng / ml, replacement therapy with iron preparations for oral administration is recommended at the rate of 200-300 mg / day (for children 100-200 mg / day). Premature babies iron supplements at a dose of 2 mg / day should be prescribed as soon as possible. Patients who donate autologous blood and are in the pre- or postoperative period should also receive adequate therapy with iron supplements at a dose of up to 200 mg / day.
In patients with uremia, the correction of anemia with epoetin alfa can cause an improvement in appetite and an increase in the absorption of potassium and proteins. In this regard, it may be necessary to periodically adjust hemodialysis parameters to maintain the level of urea, creatinine and potassium within the normal range. In these patients, it is also necessary to control the level of electrolytes in the serum.
It should be borne in mind the possibility of lowering 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 does not change, estimating the dose / response ratio. After that, the dose can be reduced or increased according to the above scheme.
Influence on ability to drive motor transport and control mechanisms
During the period of treatment until the establishment of the optimal maintenance dose, patients with uremia should avoid practicing potentially hazardous activities that require high concentration of attention and a high rate of psychomotor reactions.

Drug interaction

With simultaneous use of Epocrin with cyclosporine, the binding of the latter to red blood cells increases (a dose adjustment of cyclosporine may be required).
Based on the experience of the clinical use of Epocrin available to date, no evidence of its pharmacological incompatibility with other drugs has been identified. Nevertheless, in order to avoid possible incompatibility or decrease in activity, Epocrin should not be mixed with solutions of other drugs.

Overdose

Symptoms: possible increased side effects.
Treatment: conducting symptomatic therapy. With a high level of hemoglobin and hematocrit, bleeding is indicated.

Storage conditions

The drug should be stored at a temperature of 2 ° to 8 ° C.