Vero-epoetin lyophilizate 2 thousand IU

Epoietin beta is a glycoprotein that specifically stimulates erythropoiesis, activates mitosis and maturation of erythrocytes from erythrocyte precursor cells.

Indications

Symptomatic anemia in chronic kidney disease in patients on dialysis.

Symptomatic anemia of renal genesis in patients not yet receiving dialysis. Prevention and treatment of anemia in patients with solid tumors, anemia in which was a consequence of antitumor therapy.

Prevention and treatment of anemia in HIV-infected patients (AIDS) caused by the use of Zidovudine.

Prevention and treatment of anemia in patients with myeloma disease, non-Hodgkins lymphoma of low malignancy, chronic lympholeukosis, rheumatoid arthritis.

Treatment and prevention of anemia in premature infants born with low birth weight up to 1.5 kg.

To decrease the volume of transfused blood in major surgical interventions and acute blood loss.

Active ingredient

Epoetin beta

Composition

Recombinant Human Erythropoietin 1000 ME 2000 ME 4000 ME 10000 ME

How to take, the dosage

Vero-epoetin solution is prepared by adding 1 ml of physiological solution to the lyophilizate.

Treatment of anemia in patients with chronic kidney disease

Vero-epoetin is administered subcutaneously or intravenously (within 2 minutes). In patients on hemodialysis – via an arteriovenous shunt at the end of a dialysis session.

Patients who are not receiving hemodialysis should preferably receive the drug subcutaneously to avoid peripheral vein puncture. The treatment goal is a hemoglobin (Hb) index of 100-120 g/l. Hb should not exceed 120 g/l. If Íb is more than 20 g/l (1.3 mmol/l) during 4 weeks the dose should be reduced. In patients with arterial hypertension, cardiovascular and cerebrovascular diseases the weekly Hb increase and its target values should be determined individually, depending on the clinical picture. The patient should be carefully monitored in order to choose the minimum dose, sufficient to maximize the effect of the preparation.

The treatment with the preparation Vero-epoietin consists of two stages:

1. correction stage: When Vero-epoetin is administered subcutaneously, the initial single dose is 20 IU/kg 3 times a week. In case of insufficient Hb increase (less than 2.5 g/l per week) the dose can be increased every 4 weeks by 20 IU/kg 3 times per week. The total weekly dose of the drug can also be divided into daily doses. When administering Vero-epoetin intravenously, the initial dose is 40 IU/kg 3 times a week. In case of insufficient Hb increase in a month the dose can be increased up to 80 ME/kg 3 times a week.

If necessary the dose should be further increased by 20 ME/kg 3 times a week with a monthly interval.

Irrespective of the way of administration the maximum dose should not exceed 720 IU/kg/week.

2. Maintenance therapy stage: In order to maintain the target index of Hb (100-120 g/kg) the dose should be twice as less as the previous one. Then the maintenance dose of Vero-epoetin is chosen individually with 2 or 4 week intervals. When administered subcutaneously, the dose may be administered in 1 dose or divided into 3 or 7 injections per week. After stabilization on the background of single administration once a week it is possible to switch to single administration at two-week intervals, in which case it may be necessary to increase the dose.

The treatment is usually carried out for a long time. If necessary it can be interrupted at any time.

Prevention and treatment of anemia in patients with solid tumors

Before treatment it is recommended to determine the level of endogenous erythropoietin. If serum erythropoietin concentration is less than 200 IU/ml, the initial dose of Vero-epoietin is 150 IU/kg by intravenous administration. When administered subcutaneously, 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 dose increases do not seem to be reasonable. It is not recommended to administer erythropoietin to patients with endogenous erythropoietin content in serum of more than 200 IU/ml.

Prevention and treatment of anemia in patients with HIV infection

Intravenous administration of epoetin beta at a dose of 100 to 150 IU/kg 3 times per week is effective in HIV patients receiving Zidovudine therapy, provided the patient’s serum endogenous erythropoietin level is less than 500 IU/ml and the Zidovudine dose is less than 4,200 mg/week. When administered subcutaneously, the dose of Vero-epoetin can be reduced by 1.5 times.

Prevention and treatment of anemia in patients with myeloma disease, non-Hodgkin’s lymphoma of low malignancy and chronic lympholeukosis.

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

Prevention and treatment of anemia in patients with rheumatoid arthritis

Patients with rheumatoid arthritis have inhibition of endogenous erythropoietin synthesis under the influence of increased concentration of proinflammatory cytokines. Treatment of anemia in these patients is carried out with Vero-epoetin by subcutaneous injection at a dose of 50-75 IU/kg 3 times a week. If after 4 weeks of treatment the hemoglobin content increases less than 10 g/l, the dose of Vero-epoetin is increased up to 150-200 ME/kg 3 times a week. The further dose increasing is inexpedient

>Treatment and prophylaxis of anemia in premature infants born with low body weight

Vero-epoetin is injected subcutaneously in a dose of 250 ME/kg 3 times a week from the 3rd day of life till the target values of hemoglobin and hematocrit are achieved, but not longer than 6 weeks.

Anemia prophylaxis in major surgical interventions and acute blood losses

Vero-epoietin is administered intravenously or subcutaneously three times a week in a dose of 100-150 IU/kg until normalization of hematocrit and hemoglobin content.

Interaction

At simultaneous use of cyclosporine it may be necessary to adjust the dose of the latter due to its increased erythrocyte binding.