Vero-Epoetin lyophilisate for solution 2000 IU 10 pcs buy with delivery at wholesale prices in Moscow

pharmachologic effect

Hematopoiesis stimulator. Recombinant epoetin beta is a glycoprotein synthesized in mammalian cells into which the gene encoding human erythropoietin is embedded. Its composition, biological and immunological properties are identical to endogenous human erythropoietin.

Specifically stimulates erythropoiesis, activates mitosis and maturation of red blood cells from the precursor cells of the erythrocyte series. The administration of the drug leads to an increase in hemoglobin and hematocrit levels, improvement of blood supply to tissues and heart function.

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

Vero-epoetin lyophilisate for the preparation of solution for IV/SC 10000 IU 1 pc. in Solnechnogorsk

or
i.v.
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Treatment of anemia in patients with chronic renal failure:

subcutaneously or intravenously, for patients on hemodialysis - through an arteriovenous shunt at the end of the dialysis session. When changing the route of administration, the drug is administered at the same dose, then the dose is adjusted if necessary (with the subcutaneous route of administration of Vero-Epoetin, to achieve the same therapeutic effect, a dose of 20–30% less is required than with intravenous administration). Treatment with Vero-Epoetin includes two stages:

I. Correction stage:

with subcutaneous administration of Vero-Epoetin, the initial single dose is 30 IU/kg 3 times a week. When administering Vero-Epoetin intravenously, 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 achieved. These indicators must be monitored weekly. The following situations are possible:

1) Hematocrit increases from 0.5 to 1% 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% per week. In this case, it is necessary to reduce the 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 a correctly selected individual treatment regimen.

II. Maintenance therapy phase:

to maintain hematocrit at a level of 30–35%, the dose of Vero-Epoetin used at the correction stage should be reduced by 1.5 times. Then the maintenance dose of Vero-Epoetin is selected individually, taking into account the dynamics of hematocrit and hemoglobin.

After stabilization of hemodynamic parameters, it is possible to switch to the administration of Vero-Epoetin 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. When the concentration of serum erythropoietin is less than 200 IU/ml, the initial dose of Vero-Epoetin for intravenous administration is 150 IU/kg. With the subcutaneous route of administration, the initial dose of Vero-Epoetin can be reduced to 100 IU/kg. If there is no response, the dose may be increased to 300 IU/kg. Further increase in dose seems inappropriate. It is not recommended to prescribe erythropoietin to patients with serum endogenous erythropoietin levels above 200 IU/ml.

Prevention and treatment of anemia in patients with HIV infection:

IV epoetin beta 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 per week. With subcutaneous administration, the dose of Vero-Epoetin can be reduced by 1.5 times.

Prevention and treatment of anemia in patients with multiple myeloma, low-grade non-Hodgkin lymphomas and chronic lymphocytic leukemia:

in these patients, the advisability of treatment with epoetin beta is determined by the inadequate synthesis of endogenous erythropoietin against the background of the development of anemia. If the hemoglobin content is below 100 g/l and serum erythropoietin is below 100 IU/ml, Vero-Epoetin is administered subcutaneously at a starting dose of 100 IU/kg 3 times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly. If necessary, the dose of epoetin beta is adjusted upward or downward every 3–4 weeks. If, upon reaching a weekly dose of 600 IU/kg, an increase in hemoglobin levels is not observed, further use of epoetin beta should be discontinued as ineffective.

Prevention and treatment of anemia in patients with rheumatoid arthritis:

in patients with rheumatoid arthritis, suppression of the synthesis of endogenous erythropoietin is observed under the influence of increased concentrations of proinflammatory cytokines. Treatment of anemia in these patients is carried out with Vero-Epoetin with subcutaneous administration 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 Vero-Epoetin is increased to 150–200 IU/kg 3 times a week. Further increase in dose seems inappropriate.

Treatment and prevention of anemia in premature infants born with low birth weight:

Vero-Epoetin 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 values are achieved, but not more than 6 weeks.

Prevention of anemia during major surgical interventions and acute blood loss:

Vero-epoetin is administered intravenously or subcutaneously 3 times a week at a dose of 100–150 IU/kg until hematocrit and hemoglobin content normalize.

Indications

Prevention and treatment of anemia:

- in patients with chronic renal failure (including those on hemodialysis);

— in patients with solid tumors during antitumor therapy;

- for HIV infection (caused by the use of zidovudine);

- with multiple myeloma;

- for low-grade non-Hodgkin's lymphomas;

— for chronic lymphocytic leukemia;

- for rheumatoid arthritis;

- in premature newborns born weighing less than 1.5 kg.

To reduce the volume of blood transfused during major surgical interventions and acute blood loss.

Vero-Epoetin

Treatment of anemia in patients with chronic renal failure: subcutaneously or intravenously for 2 minutes, for hemodialysis patients - through an arteriovenous shunt at the end of the dialysis session. For patients not receiving hemodialysis, it is preferable to administer the drug subcutaneously to avoid accidental entry into peripheral veins. The goal of treatment is to achieve a hematocrit of 30-35% or eliminate the need for blood transfusion. The weekly increase in hematocrit should not exceed 0.5%. In patients with arterial hypertension, cardiovascular and cerebrovascular diseases, the weekly increase in hematocrit and its weekly indicators should be determined individually depending on the clinical picture. For some patients, the optimal rate is below 30%.

Correction stage: subcutaneous injection, initial dose - 20 IU/kg 3 times a week. In case of insufficient increase in hematocrit (less than 0.5% per week), every 4 weeks the dose can be increased to 40 IU/kg 3 times a week. The total weekly dose can be divided into daily administrations in smaller doses or administered in one dose.

When administered intravenously (slowly over 2 minutes), the initial dose is 40 IU/kg 3 times a week. If there is insufficient increase in hematocrit after 4 weeks, the dose can be increased to 80 IU/kg 3 times a week. If it is necessary to further increase the dose, it can be increased by 20 IU/kg 3 times a week at 4-week intervals. Regardless of the route of administration, the maximum dose should not exceed 720 IU/kg/week.

Maintenance therapy: to maintain the hematocrit within 30-35%, the dose is initially reduced by 2 times from the dose of the previous injection. Subsequently, the maintenance dose is selected for each patient individually, at intervals of 1-2 weeks, so that the hematocrit is maintained within 30-35%. For subcutaneous administration, the weekly dose can be administered in one dose or divided into 3 or 7 administrations per week. When the condition stabilizes, you can switch to a single dose with an interval of 2 weeks; in this case, you may need to increase the dose. Treatment is lifelong and can be interrupted if necessary.

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

Prevention of anemia in premature newborns: subcutaneously, at a dose of 250 IU/kg 3 times a week. The course of treatment is 6 weeks. Treatment should begin as early as possible, preferably from the 3rd day of life.

Prevention and treatment of anemia in cancer patients: for patients with solid tumors receiving chemotherapy with Pt drugs, treatment is indicated if Hb before chemotherapy is not higher than 130 g/l. SC, initial dose - 450 IU/kg/week, divided into 3 or 7 injections. If the increase in Hb is not sufficient, the dose is doubled after 4 weeks. Treatment is continued until 3 weeks after the end of chemotherapy. If during the first cycle of chemotherapy, Hb, despite treatment with the drug, decreases by more than 10 g/l, further use of the drug may be ineffective. An increase in Hb of more than 20 g/l per month or above 140 g/l should be avoided. If Hb increases by more than 20 g/l per month, the dose is reduced by 50%. If Hb exceeds 140 g/L, the drug is discontinued until Hb decreases to 120 g/L or less, and then treatment is resumed at a dose of 50% of the previous weekly dose.

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

For 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 within 4 weeks of treatment Hb increases by more than 20 g/l, the dose is reduced by 2 times. If Hb exceeds 140 g/l, treatment must be interrupted until Hb reaches 130 g/l or less, after which therapy is resumed at a dose equal to 50% of the previous initial dose. Treatment should only be restarted if the most likely cause of the anemia is erythropoietin deficiency.

Preparing patients for donated blood collection for subsequent autohemotransfusion: IV or SC 2 times a week for 4 weeks. In cases where the hematocrit (33% or more) allows blood sampling, the drug is administered at the end of the procedure. The dose of the drug is determined individually depending on the patient’s erythrocyte reserve and the volume of blood required for autohemotransfusion. The highest dose should not exceed 1600 IU/kg per week for intravenous administration and 1200 IU/kg/week for subcutaneous administration. Throughout the course of treatment, the hematocrit should not exceed 48%.

Contraindications

- partial red cell aplasia after previous therapy with any erythropoietin;

- uncontrolled arterial hypertension;

— impossibility of carrying out adequate anticoagulant therapy;

- myocardial infarction within a month after the event;

- unstable angina;

- increased risk of deep vein thrombosis and thromboembolism as part of a pre-deposit blood collection program before surgery;

- porphyria;

- hypersensitivity to the drug or its components.

The drug should be prescribed with caution in case of thrombosis (history), malignant neoplasms, sickle cell anemia, moderate anemia without iron deficiency, refractory anemia, epilepsy and chronic liver failure.

Side effects

From the body as a whole: sometimes (at the beginning of treatment) - flu-like symptoms (dizziness, drowsiness, fever, headache, myalgia, arthralgia).

Allergic reactions: urticaria, itching, angioedema.

Immunopathological reactions: in some cases (with long-term use) - the formation of neutralizing antibodies to erythropoietin with or without the development of partial red cell aplasia.

Dermatological reactions: mild or moderate skin rash, eczema.

From the cardiovascular system: dose-dependent increase in blood pressure, worsening 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 convulsions.

From the blood coagulation system: thrombocytosis; in some cases - shunt thrombosis (in patients on hemodialysis, with a tendency to hypotension or with an aneurysm, stenosis).

Metabolism: decreased serum ferritin; in patients with uremia - hyperkalemia and hyperphosphatemia.

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

Other: breathing disorders; in some cases - exacerbation of porphyria.

Vero-Epoetin instructions for use

Active ingredient: Epoetin beta (Epoetinum beta) ATX B03XA01 Erythropoietin

Pharmacological group Hematopoiesis stimulants

Composition and release form Lyophilisate for the preparation of a solution for intravenous and subcutaneous administration 1 vial. recombinant human erythropoietin 1000 IU 2000 IU 4000 IU 10000 IU excipients: low molecular weight medical PVP; citrate-phosphate buffer to obtain a solution with pH 6.9 in colorless glass bottles I or II hydrolytic; There are 1, 5 or 10 bottles in a cardboard pack.

Description of the dosage form Porous amorphous mass of white or almost white color.

Pharmacological action Pharmacological action - hematopoietic. Pharmacodynamics Epoetin beta is a glycoprotein that specifically stimulates erythropoiesis, activates mitosis and maturation of erythrocytes from erythrocyte precursor cells. Recombinant epoetin beta is synthesized in mammalian cells into which the gene encoding human erythropoietin is integrated. In its composition, biological and immunological properties, epoetin beta is identical to natural human erythropoietin. The administration of epoetin beta leads to an increase in hemoglobin and hematocrit, improving blood supply to tissues and heart function. The most pronounced effect of the use of epoetin beta is observed in anemia caused by chronic renal failure. In very rare cases, with long-term use of erythropoietin for the treatment of anemic conditions, the formation of neutralizing antibodies to erythropoietin with or without the development of partial red cell aplasia may be observed.

Pharmacokinetics: With intravenous administration of Vero-Epoetin in healthy individuals and patients with uremia, T1/2 is 5–6 hours. With subcutaneous administration of epoetin beta, its concentration in the blood increases slowly and reaches a maximum in the period from 12 to 28 hours after administration , T1/2 - 13-28 hours. With intravenous administration, T1/2 - 4-12 hours. Bioavailability of Vero-Epoetin with subcutaneous administration - 25-40%.

Indications for the drug Vero-Epoetin Anemia in patients with chronic renal failure, including those on hemodialysis. Prevention and treatment of anemia in patients with solid tumors, whose anemia was a consequence of antitumor therapy, in HIV-infected patients (AIDS) caused by the use of Zidovudine, in patients with multiple myeloma, low-grade non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis. Treatment and prevention of anemia in premature infants born weighing up to 1.5 kg. To reduce the volume of blood transfused during major surgical interventions and acute blood loss.

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

With caution - thrombosis (history), malignant neoplasms, sickle cell anemia, moderate anemia without iron deficiency, refractory anemia, epilepsy and chronic liver failure, pregnancy, breastfeeding.

Use during pregnancy and breastfeeding Since there is no sufficient experience with the use of erythropoietin during pregnancy and breastfeeding, Vero-Epoetin should be prescribed only if the expected benefits from its use outweigh the possible risk to the fetus, child and mother.

Side effects In some cases, flu-like symptoms (dizziness, drowsiness, fever, headache, myalgia, arthralgia) are observed at the beginning of treatment. Allergic reactions are possible, namely, mild or moderate skin rash, urticaria, itching, angioedema, eczema. From the cardiovascular system: a dose-dependent increase in blood pressure is possible, a worsening 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 convulsions. From the circulatory system: thrombocytosis, in some cases - shunt thrombosis (in patients on hemodialysis with a tendency to hypotension or with an aneurysm, stenosis, etc.). Local reactions: hyperemia, burning, mild or moderate pain at the injection site (more often occur with subcutaneous administration). From laboratory parameters: decrease in serum ferritin; in patients with uremia, hyperkalemia and hyperphosphatemia may occur. Other: complications associated with breathing problems or changes in blood pressure; very rarely - immune reactions are possible (induction of antibody formation with or without the development of partial red cell aplasia), exacerbation of porphyria.

Interaction With simultaneous use of cyclosporine, it may be necessary to adjust the dose of the latter due to an increase in its binding to erythrocytes. Experience in the clinical use of Vero-Epoetin to date has not revealed any evidence of its pharmacological incompatibility with other drugs. However, to avoid possible incompatibility or decreased activity, Vero-Epoetin should not be mixed with solutions of other drugs.

Method of administration and dose SC or IV. Treatment of anemia in patients with chronic renal failure: subcutaneous or intravenous, for patients on hemodialysis - through an arteriovenous shunt at the end of the dialysis session. When changing the route of administration, the drug is administered at the same dose, then the dose is adjusted if necessary (with the subcutaneous route of administration of Vero-Epoetin, to achieve the same therapeutic effect, a dose of 20–30% less is required than with intravenous administration). Treatment with Vero-Epoetin includes two stages: I. Correction stage: with subcutaneous administration of Vero-Epoetin, the initial single dose is 30 IU/kg 3 times a week. When administering Vero-Epoetin intravenously, 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 achieved. These indicators must be monitored weekly. The following situations are possible: 1) Hematocrit increases from 0.5 to 1% 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% per week. In this case, it is necessary to reduce the 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 a correctly selected individual treatment regimen. II. Maintenance therapy stage: to maintain the hematocrit at a level of 30–35%, the dose of Vero-Epoetin used at the correction stage should be reduced by 1.5 times. Then the maintenance dose of Vero-Epoetin is selected individually, taking into account the dynamics of hematocrit and hemoglobin. After stabilization of hemodynamic parameters, it is possible to switch to the administration of Vero-Epoetin 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. When the concentration of serum erythropoietin is less than 200 IU/ml, the initial dose of Vero-Epoetin for intravenous administration is 150 IU/kg. With the subcutaneous route of administration, the initial dose of Vero-Epoetin can be reduced to 100 IU/kg. If there is no response, the dose may be increased to 300 IU/kg. Further increase in dose seems inappropriate. It is not recommended to prescribe erythropoietin to patients with serum endogenous erythropoietin levels above 200 IU/ml. Prevention and treatment of anemia in patients with HIV infection: intravenous administration of epoetin beta 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 per week. With subcutaneous administration, the dose of Vero-Epoetin can be reduced by 1.5 times. Prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin lymphomas and chronic lymphocytic leukemia: in these patients, the advisability of treatment with epoetin beta is determined by the inadequate synthesis of endogenous erythropoietin against the background of the development of anemia. If the hemoglobin content is below 100 g/l and serum erythropoietin is below 100 IU/ml, Vero-Epoetin is administered subcutaneously at a starting dose of 100 IU/kg 3 times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly. If necessary, the dose of epoetin beta is adjusted upward or downward every 3–4 weeks. If, upon reaching a weekly dose of 600 IU/kg, an increase in hemoglobin levels is not observed, further use of epoetin beta should be discontinued as ineffective. Prevention and treatment of anemia in patients with rheumatoid arthritis: in patients with rheumatoid arthritis, suppression of the synthesis of endogenous erythropoietin is observed under the influence of increased concentrations of proinflammatory cytokines. Treatment of anemia in these patients is carried out with Vero-Epoetin with subcutaneous administration 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 Vero-Epoetin is increased to 150–200 IU/kg 3 times a week. Further increase in dose seems inappropriate. Treatment and prevention of anemia in premature infants born with low body weight: Vero-Epoetin 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 values are achieved, but not more than 6 weeks . Prevention of anemia during extensive surgery and acute blood loss: Vero-epoetin is administered intravenously or subcutaneously 3 times a week at a dose of 100–150 IU/kg until hematocrit and hemoglobin content normalize.

Overdose Symptoms: increased side effects. Treatment: symptomatic, with high levels of 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 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 often if its initial level was less than 140 g/l. It must be remembered that Vero-Epoetin 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. If a hypertensive crisis develops, urgent measures are taken to provide medical care to the patient; treatment with Vero-Epoetin should be interrupted. When Vero-Epoetin is prescribed to patients with liver failure, its metabolism may slow down and erythropoiesis may be markedly increased. The safety of Vero-Epoetin in this group of patients has not been established. We also cannot exclude the possibility of Vero-Epoetin influencing the growth of certain types of tumors, incl. bone marrow tumors. The possibility that a preoperative increase in Hb levels may predispose to the development of thrombotic complications should be considered. Before starting treatment, possible causes of an inadequate reaction to the drug should be excluded (deficiency of iron, folic acid, cyanocobalamin, severe Al3+ poisoning, concomitant infections, inflammatory processes and injuries, hidden blood loss, hemolysis, bone marrow fibrosis of various etiologies) and, if necessary, adjust treatment . In most patients with uremia, cancer and HIV-infected patients, plasma ferritin levels decrease simultaneously with an increase in hematocrit. Ferritin levels must be determined throughout the course of treatment. If it is less than 100 ng/ml, oral iron replacement therapy is recommended at a rate of 200–300 mg/day (for children 100–200 mg/day). In premature infants, oral iron therapy at a dose of 2 mg/day should be prescribed as early as possible. Patients who donate autologous blood and are in the pre- or postoperative period should also receive adequate therapy with iron supplements in a dose of up to 200 mg/day. In patients with uremia, correction of anemia with epoetin beta may result in improved appetite and increased absorption of potassium and protein. In this regard, periodic adjustment of hemodialysis parameters may be required to maintain the level of urea, creatinine and K + within normal limits. Serum electrolyte levels should also be monitored in these patients. When using epoetin beta in women of reproductive age, menstruation may resume. The patient should be warned about the possibility of pregnancy and the need to use 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 hazardous activities that require increased concentration and speed of psychomotor reactions, due to an increased risk of increased blood pressure at the beginning of therapy. Given the possible more pronounced effect of epoetin beta, its dose should not exceed the dose of recombinant erythropoietin used in the previous course of treatment. During the first 2 weeks, the dose is not changed, the dose/response ratio is assessed. After this, the dose can be reduced or increased according to the scheme presented above.

Storage conditions for the drug Vero-Epoetin: In a dry place, protected from light, at a temperature of 2–8 °C. Keep out of the reach of children.

The shelf life of the drug Vero-Epoetin is 2 years. Do not use after the expiration date stated on the package.

special instructions

During treatment with Vero-epoetin, it is necessary to monitor blood pressure weekly and perform a complete blood count, including determination of hematocrit, platelets and ferritin.

In patients with uremia 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 often if its initial level was less than 140 g/l. It must be remembered that Vero-epoetin does not replace blood transfusion, but reduces the volume and frequency of its use.

In patients with controlled hypertension or thrombotic complications, an increase in the dose of antihypertensive drugs and/or anticoagulants may be required. If a hypertensive crisis develops during emergency treatment, treatment with Vero-epoetin should be interrupted.

When Vero-epoetin is prescribed to patients with liver failure, its metabolism may slow down and erythropoiesis may be significantly increased. The safety of Vero-epoetin in this group of patients has not been established.

We also cannot exclude the possibility of interaction of Vero-epoetin on the growth of certain types of tumors, incl. bone marrow tumors.

The possibility that a preoperative increase in hemoglobin levels may predispose to the development of thrombotic complications should be considered.

Before starting treatment, possible causes of an inadequate reaction to the drug should be excluded (deficiency of iron, folic acid, cyanocobalamin, severe aluminum poisoning, concomitant infections, inflammatory processes and injuries, hidden blood loss, hemolysis, bone marrow fibrosis of various etiologies) and, if necessary, adjust treatment.

In most patients with uremia, cancer and HIV-infected patients, plasma ferritin levels decrease simultaneously with an increase in hematocrit. Ferritin levels must be determined throughout the 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). In premature infants, oral iron therapy at a dose of 2 mg/day should be prescribed as early as possible.

Patients who donate autologous blood and are in the pre- or postoperative period should also receive adequate therapy with iron supplements in a dose of up to 200 mg/day.

In patients with uremia, correction of anemia with epoetin beta may result in improved appetite and increased absorption of potassium and protein. In this regard, periodic adjustment of hemodialysis parameters may be required to maintain the levels of urea, creatinine and potassium within normal limits. Serum electrolyte levels should also be monitored in these patients.

Considering the possible more pronounced effect of Vero-epoetin, 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 and the dose/response ratio is assessed. After this, the dose can be reduced or increased.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, until the optimal maintenance dose is established, patients with uremia should avoid engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to an increased risk of increased blood pressure at the beginning of therapy.

Vero-Epoetin 2000ME lyof for prepared solution for injection No. 10

Dosage

2000 IU

Active substance

Epoetin beta

Manufacturer

LENS-Pharm LLC (Russia)

Shelf life

2 years

Storage conditions

In a dry place, protected from light, at a temperature of 2–8 °C

Registration certificate number

LS-000258 dated 04/29/2005

Description of the dosage form

Porous amorphous mass of white or almost white color.

Pharmacokinetics

With intravenous administration of Vero-Epoetin in healthy individuals and patients with uremia, T1/2 is 5–6 hours. With subcutaneous administration of epoetin beta, its concentration in the blood increases slowly and reaches a maximum in the period from 12 to 28 hours after administration, T1/2 - 13-28 hours. With intravenous administration, T1/2 - 4-12 hours. Bioavailability of Vero-Epoetin with subcutaneous administration - 25-40%.

Pharmacodynamics

Epoetin beta is a glycoprotein that specifically stimulates erythropoiesis, activates mitosis and maturation of red blood cells from erythrocyte precursor cells. Recombinant epoetin beta is synthesized in mammalian cells into which the gene encoding human erythropoietin is integrated. In its composition, biological and immunological properties, epoetin beta is identical to natural human erythropoietin. The administration of epoetin beta leads to an increase in hemoglobin and hematocrit, improving blood supply to tissues and heart function. The most pronounced effect of the use of epoetin beta is observed in anemia caused by chronic renal failure. In very rare cases, with long-term use of erythropoietin for the treatment of anemic conditions, the formation of neutralizing antibodies to erythropoietin with or without the development of partial red cell aplasia may be observed.

Contraindications

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

Carefully

- thrombosis (history), malignant neoplasms, sickle cell anemia, moderate anemia without iron deficiency, refractory anemia, epilepsy and chronic liver failure, pregnancy, breastfeeding.

Use during pregnancy and breastfeeding

Since there is no sufficient experience with the use of erythropoietin during pregnancy and breastfeeding, Vero-Epoetin should be prescribed only if the expected benefits from its use outweigh the possible risk to the fetus, child and mother.

Directions for use and doses