Epoetin beta (Epoetinum beta)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
Read on
Clinical and pharmacological group: & nbsp

Stimulators of hematopoiesis

Included in the formulation
  • Vero-epoetin
    lyophilizate in / in PC 
    VEROPHARM SA     Russia
  • Recormon®
    solution in / in PC 
    Hoffmann-La Roche Ltd.     Switzerland
  • Recormon®
    lyophilizate PC 
    Hoffmann-La Roche Ltd.     Switzerland
  • Epostim®
    solution in / in PC 
    FARMAPARK, LLC     Russia
  • Epoetin beta
    solution in / in PC 
    MICROGEN FGUP Scientific and Production Association     Russia
  • Erythropoietin
    solution in / in PC 
    BINNOFARM, CJSC     Russia
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    B.03.X.A   Other stimulators of hemopoiesis

    Pharmacodynamics:

    Recombinant human erythropoietin (a glycoprotein consisting of 165 amino acids) was obtained by genetic engineering. Specifically stimulates erythropoiesis, activates mitosis and maturation of erythrocytes from the progenitor cells of the erythrocyte series.

    Increases the number of erythrocytes, reticulocytes, hemoglobin in peripheral blood, improves blood flow to tissues and heart function. Normalizes the hematocrit values ​​for 4 weeks of regular treatment. The most pronounced effect of epoetin beta is observed in anemia caused by chronic renal insufficiency.

    Pharmacokinetics:

    Bioavailability after subcutaneous injection is 23-42%. When subcutaneous the concentration in the blood increases slowly, maximum concentration achieved after 12-28 hours, with intravenous administration - 4-12 hours Elimination by the kidneys.

    Indications:

    Anemia: in preterm neonates with a body weight of 750-1500 g; to increase blood volume for autotransfusion.

    ICD-10

    XVI.P50-P61.P61.2   Anemia of prematurity

    III.D60-D64.D63.8 *   Anemia in other chronic diseases classified elsewhere

    Contraindications:

    Uncontrolled arterial hypertension, acute disturbance of cerebral circulation or myocardial infarction in anamnesis, individual intolerance, pregnancy, breast-feeding.

    Carefully:

    Gout, nephrosclerosis, epilepsy, convulsive reactions in the anamnesis, thrombophilia, porphyria.

    Pregnancy and lactation:

    Action category for the fetus by FDA - Category C. Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Use in children

    In premature newborns: 250 IU / kg 3 times a week.

    Adults

    Subcutaneously or intravenously.

    The initial dose for patients with chronic renal failure is 20 IU / kg 3 times a week, with an insufficient increase in hematocrit, the dose is increased to 40 IU / kg 3 times a week, with low efficacy possible increase the dose by 40 IU / kg every month. The highest single dose: 250 IU / kg, the highest daily dose: 720 IU / kg.

    Side effects:

    Central and peripheral nervous system: headache, disorientation, confusion, sensory-motor disorders.

    The system of hematopoiesis: rarely thrombocytosis.

    The cardiovascular system: dose-dependent increase in blood pressure, rarely - hypertensive crisis, malignant hypertension with manifestations of encephalopathy and tonic-clonic seizure syndrome.

    Digestive system: nausea, vomiting, diarrhea.

    Musculoskeletal system: arthralgia, myalgia - at the beginning of treatment.

    Dermatological reactions: burning sensation, hyperemia at the injection site.

    Urinary system: hyperkalemia, an increase in creatinine, uric acid and urea in the blood plasma.

    Allergic reactions.

    Overdose:

    Symptoms: arterial hypertension, erythrocytosis.

    Treatment: temporary cancellation of the drug before the normalization of hematocrit indicators, antihypertensive therapy.

    Interaction:

    With the simultaneous use of drugs that affect hematopoiesis (for example, iron preparations),the stimulating effect of epoetin beta can be enhanced.

    Special instructions:

    Epoetin beta should not be mixed with other medicinal solutions. The duration of intravenous administration should be not less than 1,5-2 minutes.

    During the treatment period, one should refrain from occupations requiring increased attention and speed of psychomotor reactions.

    Instructions
    Up