Epoetin Beta - Instructions For Use, Price, Analogs, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Epoetin beta

Epoetin beta: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Epoietin beta

ATX code: B03XA01

Active ingredient: epoetin beta (Epoetin beta)

Producer: Microgen FSUE NPO (Russia)

Description and photo updated: 2018-29-11

Epoetin beta is a hematopoietic stimulant.

Release form and composition

Dosage form - solution for intravenous (i / v) and subcutaneous (s / c) administration: colorless transparent liquid [with an activity of 500, 2000, 3000 and 4000 IU (International Units) - 1 ml in ampoules, 5 or 10 ampoules in blister contour packaging, in a cardboard box 1 package; with an activity of 2000 IU - 1 ml in syringes, 1 syringe in a blister strip packaging, in a cardboard box of 1, 5 or 6 packages; each pack also contains instructions for the use of Epoetin beta].

Composition of 1 ml solution:

• active substance: epoetin beta (human recombinant erythropoietin) - 500, 2000, 3000 or 4000 ME;
• additional components: water for injection, sodium chloride, sodium citrate dihydrate, albumin solution 10%, citric acid.

Pharmacological properties

Pharmacodynamics

The active substance of the drug - epoetin beta, is a glycoprotein, which consists of 165 amino acids, as well as a mitogenic factor and a differentiation hormone, due to which it induces the formation of erythrocytes from partially determined erythropoiesis precursor cells.

In composition, immunological and biological properties, epoetin beta is identical to natural human erythropoietin.

Due to the use of the drug, the number of erythrocytes and reticulocytes, the level of hemoglobin and the rate of incorporation of iron (⁵⁹ Fe) into cells increase. Specific stimulation of erythropoiesis is noted, which is not accompanied by an effect on leukopoiesis.

The response to therapy in patients with chronic leukocytic leukemia is noted 2 weeks later than in patients with solid tumors, multiple myeloma, and non-Hodgkin's lymphomas.

Pharmacokinetics

The maximum concentration of epoetin beta after subcutaneous injection is reached within 12-28 hours, after intravenous administration - after 15 minutes.

The half-life with subcutaneous administration of the drug is 13-28 hours, with IV - 4-12 hours.

Indications for use

Epoetin beta is used to treat and prevent anemia of various origins, including those caused by the following diseases / conditions:

• relative insufficiency of endogenous erythropoietin (defined as disproportionately low concentrations of erythropoietin in the blood serum relative to the degree of anemia);
• chronic renal failure;
• solid tumors in patients receiving chemotherapy;
• multiple myeloma, low-grade non-Hodgkin's lymphomas, and chronic lymphocytic leukemia in patients receiving cancer treatment.

The drug is also prescribed for the following purposes:

• an increase in the volume of donor blood for subsequent autotransfusion;
• prevention of anemia in premature infants born before 34 weeks of gestation with a body weight of 750-1500 g

Contraindications

Epoetin beta is contraindicated in severe arterial hypertension and hypersensitivity to serum albumin.

In the case of using the drug to increase the volume of donor blood with the goal of subsequent autohemotransfusion, contraindications are also the risk of deep vein thrombosis and thromboembolism, unstable angina pectoris, stroke or myocardial infarction during the previous month.

Epoetin beta should be used with caution in the following diseases / conditions:

• moderately severe anemia [hemoglobin (Hb) - 100-130 g / l or hematocrit (Ht) - 30-39%, without iron (Fe) deficiency];
• refractory anemia in the presence of blast-transformed cells;
• liver failure;
• epilepsy;
• thrombocytosis;
• body weight less than 50 kg (if it is necessary to increase the volume of donor blood for subsequent autotransfusion);
• the period of pregnancy and breastfeeding.

Epoetin beta, instructions for use: method and dosage

Epoetin beta is administered subcutaneously or intravenously.

Treatment of anemia in chronic renal failure

Patients who are not on hemodialysis are advised to inject Epoetin beta s / c to avoid accidental ingestion of the solution into the peripheral veins. However, intravenous injections are also possible, but in smaller doses. The duration of the introduction is 2 minutes.

Patients receiving hemodialysis receive the drug at the end of the dialysis session through an arteriovenous shunt.

Treatment is carried out until the Ht level reaches 30–35% or the need for blood transfusion is eliminated.

The increase in Ht should not exceed 0.5% per week.

With concomitant cardiovascular and cerebrovascular diseases or arterial hypertension, the weekly increase in Ht and its necessary indicators are determined individually, taking into account the clinical picture. In some cases, reaching the 30% level is considered optimal.

The therapeutic scheme includes two stages:

1. Dose adjustment stage: with subcutaneous administration, the initial dose is 20 IU / kg 3 times a week. If the weekly increase in Ht is less than 0.5%, once a month the dose is increased by 20 IU / kg (at the same frequency of administration). The total weekly dose of Epoetin Beta can be administered at one time or divided into daily injections. When administered intravenously, the starting dose is 40 IU / kg 3 times a week. If necessary, after a month, the dose is increased to 80 IU / kg (with the same frequency of administration). If in this case there is an insufficient rate of increase in Ht, the dose is continued to be increased every 4 weeks by 20 IU / kg. Regardless of the method of administration of the drug, the maximum permissible weekly dose is 720 IU / kg. With an increase in Ht by more than 1% per week, a single dose of the drug is reduced;
2. Maintenance therapy: the dose selected at the end of the correction stage is reduced by 2 times. Further, for each patient individually, the doctor selects a maintenance dose, adjusting it every 1-2 weeks so that the Ht indicator is maintained at 30-35%. In the case of subcutaneous administration of the drug, the weekly dose is administered 1 time per week or divided into 3 or 7 injections per week. After stabilization of the condition, a single administration of Epoetin beta every 2 weeks is sufficient, but in a higher dose. Life-long treatment. If necessary, therapy is interrupted.

Prevention and treatment of anemia in cancer

The dosage regimen of the drug depends on the indication:

• solid tumors in patients receiving chemotherapy (in case of Hb value before chemotherapy ≤ 130 g / l): Epoetin beta is prescribed sc in an initial weekly dose of 450 IU in 3 or 7 injections. If the Hb level does not increase enough, the dose is doubled after 4 weeks. After the end of chemotherapy, treatment is continued for up to 3 weeks. When, during the first course of chemotherapy, despite the stimulation of hematopoiesis by the drug, the Hb level decreases by more than 10 g / l, further use of Epoetin beta is likely to be ineffective. An increase in Нb> 20 g / l per month should be avoided; if this happened, the dose should be halved. If the patient has Hb> 140 g / l, the drug is discontinued until this indicator decreases to ≤ 120 g / l, after which the therapy for anemia is resumed at a weekly dose, half of the previous one;
• multiple myeloma, low-grade non-Hodgkin's lymphomas: Epoetin beta is prescribed sc in an initial weekly dose of 450 IU in 1, 3 or 7 injections. If the Hb level does not increase enough (less than 10 g / l), after 4 weeks the dose is doubled. If there is no increase in Нb after 8 weeks by at least 10 g / l, the drug is canceled. The maximum permissible weekly dose is 900 IU / kg;
• chronic lymphocytic leukemia in patients receiving chemotherapy: Epoetin beta is prescribed s / c in an initial weekly dose of 450 IU in 1, 3 or 7 injections. If necessary, after 4 weeks the dose is doubled. The maximum allowable dose is 900 IU / kg. After the end of chemotherapy, treatment is continued for up to 4 weeks. If during the first 4 weeks the Hb level increases by more than 20 g / l, the dose is halved. In case of an increase in the patient's Hb> 140 g / l, Epoetin beta is canceled until it drops to 130 g / l. Thereafter, treatment is resumed at a dose of 50% of the previous initial dose, provided that it is erythropoietin deficiency that is the most likely cause of anemia.

Preparation of patients for the collection of donor blood for subsequent autohemotransfusion

Epoetin beta is administered intravenously or subcutaneously 2 times a week for 4 weeks. If Ht (≥ 33%) allows blood sampling, the drug is administered at the end of the procedure.

The doctor sets the dose individually, taking into account the patient's erythrocyte reserve and the volume of blood required for autotransfusion. The maximum weekly dose for intravenous administration is 1600 IU / kg, for subcutaneous administration - 1200 IU / kg.

During the entire treatment course, the Ht level should not exceed 48%.

Prevention of anemia in premature infants

Epoetin beta is administered sc 3 times a week at 250 IU / kg for 6 weeks.

It is recommended to start treatment as early as possible, optimally from the third day of the child's life.

Side effects

• from the immune system: itching, skin rashes, urticaria; rarely - anaphylactoid reactions;
• on the part of the hematopoietic organs: rarely - dose-dependent thrombocytosis, especially after intravenous administration of Epoetin beta (does not exceed the normal range and disappears with continued therapy); rarely - the formation of neutralizing antibodies to the drug, which may be accompanied by the development of partial red cell aplasia;
• on the part of the cardiovascular system: often - an increase in blood pressure (BP) or an increase in existing arterial hypertension (especially in the case of a rapid increase in hematocrit); possible - thromboembolism (a reliable relationship with the use of Epoetin beta has not been established), thrombosis of shunts (possibly due to inadequate heparinization, especially in patients with a tendency to hypotension or complications of arteriovenous fistula, such as aneurysm or stenosis), hypertensive crisis with symptoms of encephalopathy (confusion, headache, sensory and motor pathologies - speech disorders, gait disturbances, up to tonic-clonic seizures);
• laboratory indicators: a decrease in ferritin, accompanied by an increase in hematocrit (mainly in premature babies in the period of 12-14 days of life), a decrease in serum iron metabolism; in patients with uremia - hyperphosphatemia, hyperkalemia;
• others: headache (including migraine-like pain that comes on suddenly); rarely (especially at the beginning of treatment) - reactions at the injection site, flu-like symptoms (chills, fever, malaise, pain in the limbs, headache, ossalgia).

Overdose

Epoetin beta is characterized by a very broad therapeutic index, however, it is necessary to take into account the individual patient's response to the drug at the beginning of therapy. The formation of an excessive pharmacodynamic response is possible, i.e., the development of excessive erythropoiesis with cardiovascular complications that threaten life.

In the case of a high hemoglobin count, Epoetin beta should be temporarily canceled. If necessary, phlebotomy is performed.

special instructions

Due to the risk of developing anaphylactoid reactions, the administration of the first dose of the drug should be carried out under close medical supervision.

During the period of therapy, it is necessary to periodically check the hematocrit and hemoglobin indices until the values of 30–35% and 100–120 g / l, respectively, are reached, then the control should be carried out once a week.

In the first 8 weeks of using the drug, it is necessary to count the blood cells, especially platelets, every week. If they increase by more than 150 thousand / μl from the initial value, Epoetin beta is canceled.

During dialysis, an increase in heparin dose is often required (due to an increase in hematocrit). With inadequate heparinization, there is a risk of blockage of the dialysis system and development of shunt thrombosis, especially in patients with complications of arteriovenous fistula or a tendency to hypotension. In such cases, it is necessary to carry out early revision of the shunt and timely prevention of thrombosis (for example, by taking acetylsalicylic acid). Before the appointment of Epoetin beta, a deficiency of folic acid and cyanocobalamin should be excluded, since the lack of these substances contributes to a decrease in the effectiveness of the drug.

With a rapid increase in hematocrit, it is recommended to control blood pressure (including between hemodialysis sessions in patients who receive it), especially carefully - at the beginning of treatment for cancer patients. The increase in blood pressure is stopped with appropriate drugs, in the absence of the effect, Epoetin beta is temporarily canceled. In the event of a hypertensive crisis, urgent measures are indicated.

Oncological patients and patients preparing for subsequent autotransfusion against the background of antianemic therapy are at a higher risk of developing thromboembolic complications, although the causal relationship has not been reliably established.

When prescribing Epoetin beta before taking autologous donor blood, the standard recommendations for the donation procedure are followed: blood is taken only from patients with hematocrit ≥ 33% or hemoglobin ≥ 110 g / l. Particular care should be taken if the patient's body weight is less than 50 kg. In this case, the volume of blood taken at once should not exceed 12% of the estimated blood volume of the donor.

In most cases, an increase in hematocrit is accompanied by a decrease in serum ferritin concentration. For this reason, all patients with renal anemia with ferritin levels <100 μg / L or transferrin saturation <20% are advised to take oral iron supplements at a daily dose of 200–300 mg.

According to the same principles, treatment with iron preparations is prescribed for patients with hematological and oncological diseases. In patients with multiple myeloma, non-Hodgkin's lymphomas, and chronic lymphocytic leukemia in patients with transferrin saturation <25%, intravenous administration of Fe preparations at a dose of 100 mg per week is possible.

In patients who are preparing for blood donation for subsequent autotransfusion, and also have indications of temporary iron deficiency, Fe preparations are prescribed in a daily dose of 300 mg. In this case, treatment begins simultaneously with the use of Epoetin beta and continues until the normalization of ferritin indicators. If in this case there are signs of iron deficiency (ferritin level ≤ 20 μg / L or transferrin saturation <20%), it is necessary to consider the issue of additional IV administration of Fe preparations.

For premature infants, oral therapy with iron preparations in a daily dose of 2 mg is prescribed as early as possible (no later than 14 days of life), then their dose is adjusted depending on the concentration of serum ferritin. If the concentration persists below 100 μg / ml or there are other signs of iron deficiency, the daily dose of Fe preparations is increased to 5–10 mg and treatment is carried out until the symptoms of iron deficiency are relieved.

With inadequate use of Epoetin Beta by healthy individuals (for example, in the form of doping), there is a possibility of a sharp increase in hematocrit, which can cause life-threatening complications from the cardiovascular system.

Influence on the ability to drive vehicles and complex mechanisms

During the treatment period, it is recommended to refrain from performing potentially hazardous activities.

Application during pregnancy and lactation

The experience of using Epoetin beta in pregnant and lactating women is limited, therefore the drug is used only in cases where, in the opinion of the doctor, the benefits outweigh the possible risks.

Pediatric use

In children, including premature newborns, the drug is used according to indications.

The dose of Epoetin beta for children and adolescents is determined by age: the smaller it is, the higher the dose is needed. However, given the individual variability in response to therapy, which cannot be predicted, treatment is usually started with the standard recommended doses of the drug and subsequently, if necessary, the optimal maintenance dose is selected.

With impaired renal function

Epoetin beta is indicated for the treatment and prevention of anemia in patients with chronic renal failure.

With a sharp increase in the concentration of Al ³⁺ due to the treatment of renal failure, the effect of Epoetin beta may weaken. In this regard, the decision to prescribe the drug to patients with nephrosclerosis who are not on dialysis is made individually, since there is a risk of rapid deterioration of renal function. During therapy, careful monitoring of the concentration of potassium and phosphate in serum is necessary. If hyperkalemia develops, the drug is temporarily canceled until the potassium level returns to normal.

For violations of liver function

Liver failure is a relative contraindication to the appointment of Epoetin beta, i.e. the drug can be used with extreme caution, under close medical supervision.

Drug interactions

According to the clinical experience with the use of Epoetin beta, there were no facts of drug incompatibility while taking other drugs.

In experimental studies, it was found that erythropoietin does not enhance the myelotoxic effect of cytostatics such as etoposide, cyclophosphamide, cisplatin, fluorouracil.

In order to avoid a decrease in the activity of Epoetin beta and its possible incompatibility, mixing the drug with other medicinal solutions is prohibited.

Analogs

Analogs of Epoetin beta are Aranesp, Aeprin, Binocrit, Vero-Epoetin, Mircera, Revolide, Recormon, Epocrine, Epostim, Eporatio, Eralfon, Eprex, Erythrostim, Erythropoietin.

Terms and conditions of storage

Store at temperatures from 2 to 8 ° C in its original packaging in a dry place out of the reach of children, protected from light.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Epoetin beta

The drug is used mainly in the presence of serious indications, including for the prevention of anemia. Probably for this reason, there are no reviews of Epoetin beta on medical forums and sites.

Price for Epoetin Beta in pharmacies

The approximate price for Epoetin beta with an activity of 2000 IU is 559 rubles. for 1 ampoule with a volume of 1 ml, 673 rubles. for 1 syringe with a volume of 1 ml.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!