Erythropoietin (Epoetin beta) 2000 IU/ml 1ml 10 vials

Indications for use of the drug Erythropoietin:

Welcome Erythropoietin is indicated for the prevention and treatment of various anemias: anemia of chronic renal failure (including patients on hemodialysis);

anemia in patients with solid tumors receiving chemotherapy with platinum drugs (cisplatin 75 mg/m per cycle, carboplatin 350 mg/sq m);

anemia in adult patients with multiple myeloma and non-Hodgkin’s lymphomas low-grade chronic lymphocytic leukaemia who are receiving anticancer therapy, with a relative deficiency of endogenous erythropoietin (defined as disproportionately low relative to the degree of anemia erythropoietin concentration in the serum);

to increase the amount of blood donation for subsequent autotransfusion;

for the prevention of anaemia in premature neonates born weighing 0.750-1.5 kg to 34 weeks of pregnancy.

The active substance group:

Epoetin beta (Epoetin beta), a stimulator of Hematopoiesis

Dosage form:

lyophilisate for preparation of solution for subcutaneous injection, solution for intravenous and subcutaneous injection, lyophilisate for solution preparation for intravenous and subcutaneous administration

Contraindications:

Hypersensitivity to Erythropoietin (when you use the syringe handle Reko-Pen, including benzoic acid metabolite of benzyl alcohol), severe arterial hypertension. In the treatment of Erythropoietin to increase the volume of donated blood for autotransfusion (optional): myocardial infarction or stroke with onset less than 1 month, unstable angina, the risk of deep vein thrombosis and thromboembolism.

Method of application and dose:

Treatment of anemia in patients with chronic renal failure: n/a or I/V for 2 min, hemodialysis patients using an arteriovenous shunt at the end of the dialysis session. Patients who are not receiving hemodialysis, preferably the drug enter n/a to prevent accidental contact with a peripheral vein. The goal of the Erythropoietin treatment is to achieve a hematocrit of 30-35% or the elimination of the need for blood transfusions. Weekly increase in hematocrit should not exceed 0.5%. In patients with hypertension, cardiovascular and cerebrovascular diseases weekly increase in hematocrit and its weekly indicators should be designed individually depending on the clinical picture. For some patients, the optimal rate is below 30%.

Phase correction: n/a, the initial Erythropoietin dose is 20 IU/kg 3 times a week. In case of insufficient increase in hematocrit (less than 0.5% per week) every 4 weeks dose may be increased to 40 IU/kg 3 times a week. Total weekly dose can be divided by daily administration of smaller doses, or enter for 1 admission.

At/in the introduction of the drug (slowly over 2 min) initial dose of 40 IU/kg 3 times a week. If there is an insufficient increase in hematocrit after 4 weeks, the dose may be increased to 80 IU/kg 3 times a week. If you need to further improve the dose can be increased to 20 IU/kg 3 times a week with 4-weeks interval. Regardless of the route of administration, the maximum dose should not exceed 720 IU/kg/week.

Maintenance therapy: to maintain a hematocrit in the range of 30-35% of the dose of Erythropoietin initially, reduced by 2 times the dose of the previous injection. To further support the dose selected for each patient individually, with an interval of 1-2 weeks, the hematocrit was maintained in the range of 30-35%. When s/to the introduction of the weekly dose, you can enter for 1 admission or to divide by 3 or 7 injection per week. When you have stabilized, you can move to a single administration with an interval of 2 weeks, in that case, you may need to increase dose. Treatment is lifelong, and if you want to interrupt.

In children the dose depends on age: the younger the child, the higher the dose of Erythropoietin required. Since individual response to the drug cannot be predicted, it is advisable to start with the recommended dosing regimen.

Prevention of anaemia in preterm neonates: n/a, at a dose of 250 IU/kg 3 times a week. Treatment Erythropoietin 6 weeks. Treatment should begin as early as possible, preferably 3 days of life.

Prevention and treatment of anemia in cancer patients: patients with solid tumors receiving chemotherapy with platinum drugs, treatment is indicated when Hb prior to chemotherapy is not above 130 g/l. P/, the initial dose of 450 IU/kg/week, divided into 3 or 7 injection. If there is an insufficient increase in Hb after 4 weeks dose doubled. Treatment continued until 3 weeks after the end of chemotherapy. If during the first cycle of chemotherapy Hb, despite treatment with medication decreases more than 10 g/l, further use of the drug may be ineffective. You should avoid raising Hb more than 20 g/l per month or above 140 g/l increase in Hb by more than 20 g/l per month dose reduced by 50%. If Hb exceeds 140 g/l, the drug is canceled until Hb drops to 120g/l or less, then resume treatment at the dose, component 50% from the previous weekly dose.

In patients with multiple myeloma and non-Hodgkin’s lymphoma low-grade or chronic lymphocytic leukemia initial dose of 450 IU/kg/week. The weekly dose of Erythropoietin can be divided into 3 or 7 injection. If there is an insufficient increase in Hb after 4 weeks (less than 10 g/l) the dose is doubled. If after 8 weeks of treatment Hb not increased at least 10 g/l, the drug should be discontinued. The maximum dose should not exceed 900 IU/kg / week.

Chronic lymphocytic leukemia treatment should be continued until 4 weeks after the end of chemotherapy. The highest dose should not exceed 900 IU/kg. If over 4 weeks of treatment Hb increases more than 20 g/l dose reduced by 2 times. If Hb exceeds 140 g/l, treatment should be interrupted until Hb reaches 130 g/l or less, then resume therapy at a dose equal to 50% from the previous starting dose. Treatment should be resumed only if the most likely cause of anemia is Erythropoietin deficiency.

Prepare patients for collection of donor’s blood for subsequent autotransfusion: in/in or s/to 2 times per week for 4 weeks. In the case where the hematocrit (33% or more) allows for blood sampling, the drug is administered at the end of the procedure. The dose is determined individually depending on the patient’s RBC reserve and the volume of blood required for autotransfusion. The highest dose should not exceed 1600 IU/kg / week with/introduction, and 1200 IU/kg/week in the p/to the introduction. Throughout the course of treatment Erythropoietin hematocrit should not exceed 48%.

Pharmacological action:

The drug is a means of stimulating erythropoiesis, is a glycoprotein that is ecosocialism factor and hormone differentiation, promotes the formation of erythrocytes from stem cells. Increases the number of erythrocytes, reticulocytes, hematocrit and Hb in the blood as well as speed the inclusion of iron in the cells. Specifically affects erythropoiesis, does not affect leucopoiesis.

In chronic leukocyte leukemia response to Erythropoietin therapy comes 2 weeks later than in patients with multiple myeloma, non-Hodgkin’s lymphoma and solid tumors.

Side effects:

When receiving Erythropoietin possible side effects:

From the CCC: often – increased blood pressure or strengthening already existing hypertension, especially in the case of rapid increase of the hematocrit; hypertonic kriz events encephalopathy (confusion, headache, sensory and motor disorders – disturbance of speech, gait, until tonic-clonic seizures), pulmonary shunts (perhaps with inadequate heparinization), especially in patients with a tendency to hypotension or arteriovenous fistula complications (stenosis, aneurysm), pulmonary embolism (a clear causal relationship with the drug is not installed).

Organs of hematopoiesis: rarely – the formation of neutralizing antibodies to EPO with the development of partial red cell aplasia or without it; rare – dose-related thrombocytosis (not beyond the normal range and disappearing with continued therapy), especially after the on/in the introduction.

Laboratory findings: in patients with uremia – hyperkalemia, hyperphosphatemia. The decrease in ferritin levels (along with increased hematocrit), mostly in premature infants, especially 12 th to 14-th day of life; reduction in serum levels of Fe exchange.

Allergic reactions: itching, rash, urticaria; rarely anaphylactoid reactions.

Other: headache (including sudden migrenepodobna), and rarely flu-like symptoms (especially at the beginning of treatment): chills, fever, pain in the limbs, malaise, headache, ostalgia; reaction at the injection site.

Special instructions:

Inappropriate use of Erythropoietin in healthy people (such as doping) can cause a sharp increase in hematocrit, accompanied by life-threatening complications from the CCC.

Because of the possible development of anaphylactoid reactions, the first dose should be administered under the supervision of a physician.

You should periodically monitor the hematocrit to reach values of 30-35% (Hb 100-120 g/l). In the future, these indicators need to be determined on a weekly basis.

Due to the increase in hematocrit is often required to increase dose heparin during hemodialysis. In inadequate heparinization possible blockage of the dialysis system, thrombosis of the shunts, especially in patients with a tendency to hypotension or with complications of arteriovenous fistula (aneurysm, stenosis, etc.). In these patients, we recommend an early revision of the shunt and prevention of thrombosis (e.g., ACS).

Before treatment Erythropoietin is necessary to exclude a deficiency of cyanocobalamin and folic acid because they reduce the effectiveness of the drug.

A sharp increase in the concentration of aluminium due to treatment of kidney failure, can weaken the effectiveness of Erythropoietin.

The decision to use the drug in patients with nephrosclerosis, not undergoing dialysis, should be taken individually, since such patients are not excluded more rapid deterioration of kidney function.

During treatment with Erythropoietin is recommended to periodically monitor the concentration of K+ and phosphate in blood serum. In case of hyperkalemia you must temporarily stop the drug until normalization of the concentration of K+.

It is recommended to control the AD, including between dialysis sessions, with the rapid increase of the hematocrit, and in cancer patients especially at the beginning of treatment. Increase in blood pressure can be relieved BOS, in the absence of the effect a temporary break in treatment Erythropoietin. With the development of hypertension carried out emergency measures.

In cancer patients and in patients preparing for subsequent autotransfusion and receiving Erythropoietin, noted a higher incidence of thromboembolic complications, although a clear causal relationship to drug intake is not installed.

In the first 8 weeks of therapy required weekly counting of blood cells (especially platelets). With the increase in the number of platelets more than 150 thousand/al from baseline values, treatment should be interrupted.

If the drug is administered before the fence of autologous blood donations, you should follow the guidelines on the procedure for donation of blood can only be taken in patients with hematocrit of 33% or more (or not Hb less than 110 g/l). Special caution should be exercised in patients weighing less than 50 kg blood Volume, picking up simultaneously, must not exceed 12% of the estimated blood volume of the patient.

In most cases, simultaneously with an increase in hematocrit decreases the concentration of ferritin in serum. Therefore, all patients with anemia of renal origin and with the serum concentration of ferritin less than 100 mcg/l or transferrin saturation less than 20% that oral iron supplementation at a dose of 200-300 mg/day. Patients with cancer and haematological diseases therapy drugs Fe performed according to the same principles; the patients with multiple myeloma, non-Hodgkin’s lymphoma or chronic lymphocytic leukemia with transferrin saturation less than 25% you can enter 100 mg Fe per week. Premature children oral therapy drugs iron to a dose of 2 mg/day should be administered as early as possible (at the latest in 14 days of life). Dose Fe corrigiruut depending on the concentration of serum ferritin. If she steadfastly maintained below 100 µg/ml or there are others signs of Fe deficiency, the medication dosage of Fe should be increased to 5-10 mg/day and treat up to the relief of the symptoms of low Fe.

Patients preparing for a blood donation for subsequent autotransfusion, as well as having the instructions on a temporary Fe deficiency, oral therapy drugs Fe at a dose of 300 mg/day should be started simultaneously with the therapy Erythropoietin and continue to the normalization of ferritin. If, despite oral replacement therapy drugs Fe, develop signs of Fe deficiency (ferritin concentration of 20 µg/l or less and transferrin saturation less than 20%), it is necessary to consider additional on/in the introduction of preparations of iron.

Should be taken into consideration in patients with severe forms of phenylketonuria that some formulations of Erythropoietin as adjuvant substances contain phenylalanine.

Interaction:

The drug is incompatible with other drugs in the same syringe.