Vero-Epoetin
Vero-Epoetin: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Vero-Epoetin
ATX code: B03XA01
Active ingredient: epoetin beta (Epoetin beta)
Manufacturer: VEROPHARM JSC (Russia)
Description and photo updated: 2018-29-11
Prices in pharmacies: from 537 rubles.
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Vero-Epoetin is an erythropoiesis stimulant.
Release form and composition
Dosage form - lyophilisate for preparation of a solution for intravenous (iv) and subcutaneous (s / c) administration: amorphous porous mass of almost white or white color [in vials of 1000, 2000, 4000 or 10,000 ME (International Units); in a cardboard box 1, 5 or 10 bottles and instructions for the use of Vero-Epoetin].
The composition of the lyophilisate in 1 bottle:
- active substance: epoetin beta - 1000, 2000, 4000 or 10,000 ME;
- auxiliary components: citrate-phosphate buffer, low molecular weight medical polyvinylpyrrolidone (povidone).
Pharmacological properties
Pharmacodynamics
The active substance of Vero-Epoetin, recombinant epoetin beta, is a glycoprotein that specifically stimulates erythropoiesis, activates miosis and the maturation of erythrocytes from erythrocyte precursor cells.
Epoetin beta is synthesized in mammalian cells in which the gene encoding human erythropoietin is inserted. In composition, immunological and biological properties, this substance is identical to natural human erythropoietin.
Vero-Epoetin increases hematocrit and hemoglobin, improves tissue blood supply and heart function. The most effective drug for anemia caused by chronic renal failure.
In very rare cases, long-term use of Vero-Epoetin for the treatment of anemic conditions can cause the formation of neutralizing antibodies to erythropoietin, including with the concomitant development of partial red cell aplasia.
Pharmacokinetics
When Vero-Epoetin is administered subcutaneously, the level of epoetin beta in the blood rises slowly. The maximum reaches within 12-28 hours. Bioavailability is 25-40%. The half-life (T 1/2) can vary from 13 to 28 hours.
With the on / in the introduction T 1/2 is 4-12 hours.
Indications for use
Treatment:
- symptomatic anemia in chronic kidney disease in patients on dialysis;
- symptomatic anemia of renal origin in patients who are not yet on dialysis.
Prevention and treatment:
- anemia due to anticancer therapy in patients with solid tumors;
- anemia in patients with rheumatoid arthritis, chronic lymphocytic leukemia, multiple myeloma, and low-grade non-Hodgkin's lymphomas;
- anemia resulting from the use of zidovudine in HIV-infected patients;
- anemia in premature babies born with low body weight (up to 1.5 kg).
Vero-Epoetin is also used to reduce the volume of blood transfused and to prevent anemia in acute blood loss and major surgery.
Contraindications
Absolute:
- unstable angina;
- uncontrolled arterial hypertension;
- acute period of myocardial infarction (1 month after the attack);
- the impossibility of conducting adequate anticoagulant therapy;
- porphyria;
- an increased risk of developing deep vein thrombosis or thromboembolism as part of a pre-deposit blood collection program before surgery;
- partial red cell aplasia, which developed after previous therapy with any erythropoietin;
- hypersensitivity to any component of the drug.
Relative (Vero-Epoetin should be used with caution):
- moderate anemia without iron deficiency;
- sickle cell anemia;
- refractory anemia;
- chronic liver failure;
- a history of thrombosis;
- malignant neoplasms;
- epilepsy;
- pregnancy and lactation.
Vero-Epoetin, instructions for use: method and dosage
Vero-Epoetin is administered intravenously or subcutaneously. 1 ml of saline is added to the lyophilisate.
Treatment of anemia in chronic kidney disease
Duration of drug injection is 2 minutes.
For patients not receiving hemodialysis, in order to avoid puncture of the peripheral veins, inject Vero-Epoetin preferably sc.
For patients on hemodialysis, the solution is administered at the end of the dialysis session through an arteriovenous shunt.
Vero-Epoetin is used to achieve a hemoglobin (Hb) value of 100–120 g / l (but not more than 120). If Hb rises by more than 20 g / L (1.3 mmol / L) within 4 weeks, the dose of epoetin beta is reduced.
With arterial hypertension, cerebrovascular and cardiovascular diseases, the target Hb values and its weekly increase are determined by the doctor individually, depending on the clinical picture. Patients should be under constant medical supervision so that the minimum dose of the drug can be selected, sufficient to achieve the desired effect.
Treatment is carried out in 2 stages:
- Dose adjustment: the initial dose for subcutaneous administration is 20 IU / kg 3 times a week. If the increase in Hb is less than 2.5 g / l per week, every 4 weeks the dose is increased by 20 IU / kg (the frequency of administrations remains - 3 times a week). If necessary, the total weekly dose is divided into parts for daily administration. The initial dose for intravenous administration is 40 IU / kg 3 times a week. In case of insufficient increase in Нb, after a month, the dose is increased to 80 IU / kg 3 times a week. Regardless of the method of administration, in the future, if necessary, once a month, a single dose continues to be increased by 20 IU / kg, however, the maximum weekly dose should not exceed 720 IU / kg.
- Maintenance therapy: to maintain the target Hb (100–120 g / l), first, the dose of Vero-Epoetin is reduced by 2 times from the previously used, then the maintenance dose is individually selected, adjusting it every 2 or 4 weeks. With subcutaneous administration of the drug, the weekly dose is administered once / divided into 3 or 7 injections per week. After stabilization of Hb with the introduction of the solution once a week, you can switch to the introduction once every 2 weeks, however, an increase in the dose may be necessary.
The duration of treatment is usually long, but if necessary, it can be interrupted at any time.
Prevention and treatment of anemia in patients with solid tumors
Before the appointment of Vero-Epoetin, the level of endogenous erythropoietin in the blood serum is determined. At a concentration of <200 IU / ml, the drug is used intravenously at an initial dose of 150 mg. When administered subcutaneously, the recommended starting dose is 100 IU / kg. If the effect is insufficient, the dose is increased to 300 IU / kg. Further increase in the dose is inappropriate.
Vero-Epoetin is not used to treat patients with endogenous erythropoietin levels> 200 IU / ml.
Prevention and treatment of anemia in patients with rheumatoid arthritis
Vero-Epoetin is administered subcutaneously at 50–75 IU / kg 3 times a week. In the event that after 4 weeks the Hb index has increased by less than 10 g / l, the dose of the drug is increased to 150-200 IU / kg 3 times a week.
Further dose increases are inappropriate.
Prevention and treatment of anemia in patients with chronic lymphocytic leukemia, multiple myeloma, and low-grade non-Hodgkin's lymphomas
The appointment of epoetin beta in this category of patients is due to inadequate synthesis of endogenous erythropoietin against the background of the development of anemia.
Vero-Epoetin is administered subcutaneously.
If the Hb level is <100 g / l, and serum erythropoietin is <100 IU / ml, the initial dose of the drug is 100 IU / kg 3 times a week. Determination of hemodynamic parameters is carried out weekly.
If necessary, the dose of Vero-Epoetin is increased or decreased every 3-4 weeks.
The maximum allowable weekly dose is 600 IU / kg. If the hemoglobin level does not increase, further use of the drug is impractical.
Prevention and treatment of anemia in patients with HIV infection
Vero-Epoetin is indicated for patients receiving weekly zidovudine <4200 mg when serum endogenous erythropoietin concentrations are <500 IU / ml.
For intravenous administration, the drug is used at 100–150 IU / kg 3 times a week. With subcutaneous administration, the dose can be increased by 1.5 times.
Prevention of anemia in acute blood loss and major surgical interventions
Vero-Epoetin is administered subcutaneously or intravenously at a dose of 100–150 IU / kg 3 times a week.
The duration of treatment is determined by the moment of normalization of hematocrit and hemoglobin content.
Prevention and treatment of anemia in premature infants with low birth weight
Vero-Epoetin is administered subcutaneously at a dose of 250 IU / kg 3 times a week, starting from the third day of life.
The duration of therapy is determined by the moment the target values of hematocrit and hemoglobin are achieved, but should not exceed 6 weeks.
Side effects
- on the part of the hematopoietic system: a dose-dependent increase in the number of platelets (especially with intravenous administration of Vero-Epoetin; the platelet number does not go beyond the upper limits of the norm and stabilizes with continued therapy), thrombocytosis, shunt thrombosis (especially in patients with a tendency to lower blood pressure or complications of an arteriovenous fistula, such as aneurysm or stenosis);
- on the part of the cardiovascular system: development or intensification of existing arterial hypertension (especially with a rapid increase in hematocrit), hypertensive crisis with symptoms of encephalopathy (headache, confusion, sensory and motor disorders, including speech and gait disorders, development of tonic clonic seizures), thromboembolic complications in patients preparing for autotransfusion and cancer patients (a reliable causal relationship with the use of Vero-Epoetin has not been established);
- from the nervous system: headache, including a sudden migraine;
- laboratory parameters: a decrease in serum iron metabolism, a decrease in serum ferritin concentration and a simultaneous increase in hemoglobin; with uremia - hyperphosphatemia;
- others: reactions at the injection site, skin allergic reactions (itching, rashes, hives), anaphylactoid reactions, flu-like syndrome (especially at the beginning of therapy), manifested by chills, fever, malaise, headache, pain in the limbs or bones.
In premature infants, a decrease in the serum ferritin content, an increase in the number of platelets (especially in the period up to 12-14 days of life) is possible.
Overdose
In case of an overdose, the severity of side effects may increase.
Patients are prescribed symptomatic treatment. With a high level of hematocrit and hemoglobin, bloodletting is indicated.
special instructions
Before starting the use of Vero-Epoetin, the doctor should exclude possible causes of an inadequate reaction to the drug, for example, hemolysis, latent blood loss, inflammation, trauma, concomitant infections, bone marrow fibrosis of various etiologies, severe A 13+ poisoning, deficiency of iron, cyanocobalamin or folic acid … If necessary, the therapy regimen should be adjusted.
During the period of treatment with the drug, weekly blood pressure monitoring and a general blood test are indicated, including for the determination of platelets, hematocrit, ferritin.
In the pre- and postoperative period, hemoglobin should be more intensively monitored in patients whose baseline level was <140 g / l.
Preoperative increase in hemoglobin levels can cause thrombotic complications.
In patients with uremia on hemodialysis, an increase in the dose of heparin is usually required due to an increase in hematocrit. It is also necessary to carry out timely prevention of thrombosis and early revision of the shunt.
With controlled arterial hypertension and thrombotic complications, Vero-Epoetin is able to reduce the effect of antihypertensive drugs and / or anticoagulants, which may require an increase in their doses.
In the case of the development of a hypertensive crisis, urgent measures are indicated. The introduction of Vero-Epoetin is stopped.
There is a potential risk that epoetin beta may affect the growth of certain types of tumors, including bone marrow tumors.
Given the likelihood of a more pronounced effect of the drug in patients with uremia, the dose of Vero-Epoetin should not be higher than the dose of recombinant erythropoietin used in the previous course of treatment. During the first 2 weeks, the dose is not changed, only the ratio of the administered dose and the response to therapy is assessed. In the future, the dose is increased or decreased if necessary.
Due to the correction of anemia in patients with uremia, it is possible to improve appetite, increase the absorption of proteins and potassium. Periodic adjustments of hemodialysis parameters are required to maintain levels of potassium, urea and creatinine within the normal range. Serum electrolyte levels should also be monitored.
In the majority of HIV-infected patients, patients with uremia and oncology, a decrease in the level of ferritin occurs simultaneously with an increase in hematocrit. Therefore, it must be determined regularly during the entire treatment period. If this indicator is <100 ng / ml, it is recommended to prescribe replacement therapy with oral iron preparations (adults - 200-300 mg per day, children - 100-200 mg per day). For premature infants, iron supplements are prescribed at a dose of 2 mg / day, therapy is started as early as possible.
Adequate therapy with iron preparations is also required for patients who donate blood, and for patients who are in the pre- or postoperative period (in daily doses up to 200 mg).
In women of reproductive age, menstruation may resume during therapy. The doctor should warn about the likelihood of pregnancy, the need to use reliable methods of contraception before and during treatment.
Influence on the ability to drive vehicles and complex mechanisms
Patients with uremia during the selection of the optimal maintenance dose are advised to refrain from performing work with potentially dangerous consequences, including driving a car, which is associated with the risk of increased blood pressure at the initial stage of therapy.
Application during pregnancy and lactation
Clinical experience with the use of epoetin beta during pregnancy and lactation is insufficient to determine the degree of its effect. In this regard, Vero-Epoetin is prescribed only in cases where the expected benefit is definitely higher than the potential risks.
Pediatric use
Vero-Epoetin can be used in children, including premature babies, if indicated.
For violations of liver function
In liver failure, the metabolism of epoetin beta may slow down and erythropoiesis may increase significantly. The safety of the drug in this group of patients has not been established, therefore Vero-Epoetin should be used with caution.
Drug interactions
Epoetin beta increases the binding of cyclosporin to red blood cells, which may require dose adjustment of the latter.
In the course of clinical experience with the use of Vero-Epoetin, no facts of its pharmacological incompatibility with other drugs have been identified. To avoid the risk of possible interactions, do not mix epoetin beta with solutions of other drugs.
Analogs
The analogues of Vero-Epoetin are Aranesp, Aeprin, Binocrit, Mircera, Revolide, Recormon, Epocrine, Eporatio, Epostim, Epoetin beta, Eprex, Eralfon, Erythropoietin, Erythrostim.
Terms and conditions of storage
Store at a temperature of 2–8 ° C out of the reach of children, dry and protected from light.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Vero-Epoetin
On specialized sites and forums, there are mainly messages in which patients with renal failure compare this drug with Recormon. According to their reviews, Vero-Epoetin is less effective, more inconvenient to use (since it is not produced in the form of a ready-made solution for injection), and its injections are more painful.
Price for Vero-Epoetin in pharmacies
Approximate prices for Vero-Epoetin (for 1 bottle): 2000 IU - 420-548 rubles; 10,000 IU - 3150 rubles.
Vero-Epoetin: prices in online pharmacies
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Drug name Price Pharmacy |
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Vero-Epoetin 2000 IU lyophilisate for preparation of solution for intravenous and subcutaneous administration 1 pc. RUB 537 Buy |
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Vero-Epoetin 2000 IU lyophilisate for preparation of solution for intravenous and subcutaneous administration of 10 pcs. 3490 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
