Erythrostim® (Solution) Instructions for Use
ATC Code
B03XA (Other anti-anemic drugs)
Active Substance
Epoetin beta (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Erythropoiesis stimulant
Pharmacotherapeutic Group
Hematopoiesis stimulant
Pharmacological Action
Recombinant human erythropoietin (a purified glycoprotein) consisting of 165 amino acids, which, being a mitogenic factor and a differentiation hormone, promotes the formation of erythrocytes from partially determined erythroid progenitor cells.
Recombinant Epoetin beta, obtained by genetic engineering, is identical to human erythropoietin in its amino acid and carbohydrate composition.
Epoetin beta, after intravenous and subcutaneous administration, increases the number of erythrocytes, reticulocytes, and hemoglobin level, as well as the rate of iron (59Fe) incorporation into cells, specifically stimulates erythropoiesis without affecting leukopoiesis.
No cytotoxic effect of epoetin beta on the bone marrow or on human skin cells has been identified.
Pharmacokinetics
After subcutaneous administration, Cmax in plasma is reached after 12-28 hours. The bioavailability of epoetin beta after subcutaneous administration is 23-42% compared to intravenous administration. Vd is equal to the blood volume or twice its value. T1/2 in the terminal phase is 13-28 hours. After intravenous administration, the T1/2 of the active substance is 4-12 hours. The T1/2 of the terminal phase after subcutaneous administration is longer than after intravenous administration and averages 13-28 hours.
Indications
Symptomatic anemia in chronic kidney disease in patients on dialysis; symptomatic anemia of renal origin in patients not yet receiving dialysis; treatment of symptomatic anemia in adult patients with solid and hematological non-myeloid tumors receiving chemotherapy; prevention of anemia in premature newborns born with a body weight of 750-1500 g before the 34th week of pregnancy.
Increasing the volume of donor blood intended for subsequent autotransfusion. The registered risk of thromboembolic events should be taken into account. Use for this indication is indicated only in patients with moderate anemia (Hb 100-130 g/L (6.21-8.07 mmol/L), without iron deficiency), if obtaining a sufficient amount of preserved blood is impossible, and a planned major elective surgical intervention may require a large volume of blood (>4 units for women or >5 units for men).
ICD codes
| ICD-10 code | Indication |
| D63.0 | Anemia in neoplastic disease (C00-D48*) |
| D63.8 | Anemia in other chronic diseases classified elsewhere* |
| P61.2 | Anemia of prematurity |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| 3A71.Z | Anemia of chronic disease, unspecified |
| KA8B | Anemia of prematurity |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
The drug is administered intravenously, the duration of administration is at least 2 minutes, or subcutaneously (with subcutaneous administration, smaller doses should be administered).
For patients on hemodialysis, Erythrostim® is administered intravenously through an arteriovenous fistula immediately after a hemodialysis session. The drug should not be administered together with solutions of other medicinal products.
The initial dose of the drug is 50 IU/kg 3 times a week.
During treatment, it is necessary to monitor the rate of hematocrit increase. If the hematocrit increases by more than 0.5% per week, the dose is not changed. If the hematocrit increase is less than 0.5% per week, the dose is increased by 25 IU/kg every 4 weeks.
The maximum dose is 200 IU/kg 3 times a week.
The goal of therapy is to achieve a hematocrit level of 30-35%, and hemoglobin of 100-120 g/L, after which the last dose should be reduced by 50% and doses should be individually selected to maintain the desired hematocrit level (30-35%).
For prevention of anemia in premature newborns, the administration of Erythrostim® should begin as early as possible, preferably from the 3rd day of life. The duration of treatment is 6 weeks.
The effectiveness of the drug in premature newborns who received hemotransfusions is somewhat less than in those who did not receive hemotransfusions.
Adverse Reactions
From the cardiovascular system arterial hypertension, hypertensive crisis, shunt thromboses.
From the nervous system encephalopathy (more often with hypertensive crises), headache, confusion.
From the blood coagulation system rarely – thrombocytosis, thrombotic complications.
From the hematopoietic system: pure red cell aplasia (PRCA).
Allergic reactions rarely – skin rash, itching, urticaria, anaphylactoid reactions.
From the skin and subcutaneous tissues Stevens-Johnson syndrome.
From laboratory parameters decrease in plasma ferritin content with a simultaneous increase in hemoglobin, increase in plasma potassium and phosphate levels.
Other flu-like syndrome, local reactions.
Contraindications
Hypersensitivity to epoetin beta in history; uncontrolled arterial hypertension; myocardial infarction or stroke within the previous month, unstable angina or increased risk of deep vein thrombosis (with a history of venous thromboembolism) – when prescribed to increase the volume of donor blood for autologous blood transfusion.
With caution
Refractory anemia in the presence of blast-transformed cells, thrombocytosis, epilepsy and chronic liver failure. Body weight less than 50 kg for increasing the volume of donor blood for subsequent autologous transfusion.
Use in Pregnancy and Lactation
During pregnancy and breastfeeding, Epoetin beta is used only if the intended benefit to the mother outweighs the potential risk to the fetus or child.
In experimental studies, no teratogenic effect was identified.
Use in Hepatic Impairment
Use with caution in chronic liver failure.
Use in Renal Impairment
Use with caution in patients with nephrosclerosis not receiving hemodialysis, as a more rapid deterioration in renal function is possible.
Pediatric Use
It is possible to use in children according to indications, in doses and regimens recommended according to age.
For the treatment of anemia associated with chronic kidney disease, Epoetin beta should not be prescribed to children under 2 years of age.
Special Precautions
During therapy with epoetin beta, platelet, hematocrit and hemoglobin levels should be regularly monitored.
Epoetin beta should be used with caution in refractory anemia in the presence of blast-transformed cells, epilepsy, thrombocytosis and chronic liver failure.
The therapeutic efficacy of epoetin beta may decrease with iron, folic acid, vitamin B12 deficiency.
Iron deficiency should be ruled out before starting treatment with epoetin beta, as well as throughout the entire period of therapy. If necessary, additional therapy with iron preparations may be prescribed in accordance with clinical guidelines.
The effectiveness of treatment decreases with iron deficiency in the body, with infectious and inflammatory diseases, hemolysis.
The possibility of the influence of epoetin beta on the growth of some types of tumors, especially on malignant neoplasms of the bone marrow, cannot be completely excluded.
During the use of epoetin beta, blood pressure levels should be monitored, paying attention to the occurrence or intensification of unusual headaches. In this case, correction of the ongoing therapy or prescription of antihypertensive agents may be required.
Use with caution in epilepsy, thrombocytosis, liver failure, vascular insufficiency, in malignant neoplasms; in patients with nephrosclerosis not receiving hemodialysis, as a more rapid deterioration in renal function is possible.
The decision to use epoetin beta in patients with nephrosclerosis not receiving dialysis should be made individually, since the possibility of a more rapid deterioration in renal function cannot be completely excluded. In most cases, along with an increase in hemoglobin, the serum ferritin concentration decreases. Ferritin levels should be determined throughout the entire course of treatment. If it is less than 100 ng/ml, replacement therapy with iron preparations is recommended.
Patients donating autologous blood and in the pre- or postoperative period should also receive an adequate amount of iron additionally until ferritin levels normalize.
Drug Interactions
With simultaneous use of drugs affecting hematopoiesis (for example, iron preparations), the stimulating effect of epoetin beta may be enhanced.
Epoetin beta should not be mixed with solutions of other medicinal products.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for intravenous and subcutaneous administration 500 IU/1 ml: amp. 5, 10, or 100 pcs., vials 50 pcs.
Solution for intravenous and subcutaneous administration 2000 IU/1 ml: amp. 5, 10, 50, or 100 pcs., vials 50 or 100 pcs.
Solution for intravenous and subcutaneous administration 3000 IU/1 ml: amp. 5, 10, 50, or 100 pcs., vials 50 or 100 pcs.
Solution for intravenous and subcutaneous administration 4000 IU/1 ml: amp. or vials 5, 10, 50, or 100 pcs.
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Official Distributor
MEGARD GROUP, LLC (Russia)
Dosage Forms
 |
Erythrostim® | Solution for intravenous and subcutaneous administration 500 IU/1 ml: amp. 5, 10, or 100 pcs., vials 50 pcs. |
| Solution for intravenous and subcutaneous administration 2000 IU/1 ml: amp. 5, 10, 50, or 100 pcs., vials 50 or 100 pcs. | ||
| Solution for intravenous and subcutaneous administration 3000 IU/1 ml: amp. 5, 10, 50, or 100 pcs., vials 50 or 100 pcs. | ||
| Solution for intravenous and subcutaneous administration 4000 IU/1 ml: amp. or vials 5, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and subcutaneous administration transparent, colorless.
| 1 ml | |
| Human recombinant erythropoietin | 500 IU |
Excipients : albumin (10% solution), sodium citrate dihydrate, sodium chloride, citric acid, water for injections.
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
Solution for intravenous and subcutaneous administration transparent, colorless.
| 1 ml | |
| Human recombinant erythropoietin | 2000 IU |
Excipients : albumin (10% solution), sodium citrate dihydrate, sodium chloride, citric acid, water for injections.
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
Solution for intravenous and subcutaneous administration transparent, colorless.
| 1 ml | |
| Human recombinant erythropoietin | 3000 IU |
Excipients : albumin (10% solution), sodium citrate dihydrate, sodium chloride, citric acid, water for injections.
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
Solution for intravenous and subcutaneous administration transparent, colorless.
| 1 ml | |
| Human recombinant erythropoietin | 4000 IU |
Excipients : albumin (10% solution), sodium citrate dihydrate, sodium chloride, citric acid, water for injections.
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
Solution for injection 10,000 IU/1 ml: amp. 5, 10, 50, or 100 pcs., fl. 5, 10, 50, or 100 pcs.
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
|
Erythrostim® | Solution for injection 10,000 IU/1 ml: amp. 5, 10, 50, or 100 pcs., fl. 5, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, colorless.
| 1 ml | |
| Human recombinant erythropoietin | 10,000 IU |
Excipients : human serum albumin, isotonic citrate buffer solution.
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
1 ml – vials (5) – cardboard packs.
1 ml – vials (10) – cardboard packs.
1 ml – ampoules (5) – cardboard packs (10) – cardboard boxes.
1 ml – ampoules (10) – cardboard packs (10) – cardboard boxes.
1 ml – vials (5) – cardboard packs (10) – cardboard boxes.
1 ml – vials (10) – cardboard packs (10) – cardboard boxes.
![Erythrostim® [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Erythrostim® [Solution] 2")