Treatment of anemia in patients with chronic renal failure:
Epostim® is administered intravenously or subcutaneously. Patients who are on hemodialysis, the drug is injected through the arteriovenous shunt at the end of the dialysis session. When the mode of administration is changed, the drug is administered in the same dose,then the dose is corrected if necessary (with a subcutaneous method of Epostim® administration, a 20-30% dose is required to achieve the same therapeutic effect than with intravenous administration). Epostim® treatment includes two stages:
1. Correction phase: With subcutaneous administration of Epostim, the initial single dose is 30 IU / kg 3 times a week. When intravenously administered Epostima®, the initial single dose is 50 IU / kg. The correction period lasts until the optimal hemoglobin level is reached (100-120 g / l in adults and 95-110 g / l in children) and hematocrit (30-35%). These indicators need to be monitored weekly. The following situations are possible:
1) The hematocrit rises from 0.5 to 1.0 % in Week. In this case, the dose is not changed until optimal values are achieved.
2) The growth rate of hematocrit is less than 0.5% per week. In this case it is necessary to increase the single dose by 1.5 times.
3) The growth rate is more than 1.0% per week. In this case, it is necessary to reduce the single dose of the drug by a factor of 1.5.
4) The hematocrit remains low or decreases. It is necessary to analyze the causes of resistance.
The effectiveness of therapy depends on a properly selected individual treatment regimen.
2. Stage of maintenance therapy: To maintain hematocrit at 30-35% dose Epostim®, achieved at the stage of correction, should be reduced by 1.5 times. Then the maintenance dose of Epostim® is selected individually taking into account the dynamics of hematocrit and hemoglobin. After stabilization of hemodynamic parameters, it is possible to switch to Epostim® once every 1-2 weeks.
Prevention and treatment of anemia in patients with solid tumors:
Before the start of treatment it is recommended to carry out a determination of the level of endogenous erythropoietin. When the erythropoietin concentration in the serum is less than 200 IU / L, the initial dose of Epostim® is 150 IU / kg 3 times a week for the intravenous route. With the subcutaneous route of administration, the initial dose of Epostim® can be reduced to 100 IU / kg 3 times a week. If there is no answer, an increase in the dose to 300 IU / kg is possible 3 times a week. Further increase in the dose seems inappropriate. It is not recommended to appoint erythropoietin to patients with endogenous erythropoietin content in serum above 200 IU / L.
During therapy with Epostim®, it is undesirable to increase the hemoglobin level by more than 20 g / l per month or above 140 g / l.If the hemoglobin level is increased by more than 20 g / L per month, Epostim® dose should be halved. If the hemoglobin level exceeds 140 g / l, Epostim® is canceled until the hemoglobin level decreases <120 g / l, after which the treatment resumes at a dose equal to 50% of the dose at which the drug was withdrawn.
Prevention and treatment of anemia in patients with HIV infection:
Intravenous administration of Epistima® at a dose of 100-150 IU / kg 3 times a week is effective in HIV-infected patients receiving zidovudine, provided that the level of endogenous erythropoietin in the serum of the patient is less than 500 IU / L, and the dose of zidovudine is less than 4200 mg per week. When administered subcutaneously, the dose of Epostima® can be reduced by a factor of 1.5.
Prevention and treatment of anemia in patients with myeloma, non-Hodgkin's lymphomas of low grade and with chronic lymphocytic leukemia: In these patients, the feasibility of epoetin beta treatment is due to an inadequate synthesis of endogenous erythropoietin against the background of anemia. If the hemoglobin content is below 100 g / l and the serum erythropoietin is below 100 IU / L Epostim® is administered subcutaneously at a starting dose of 100 IU / kg three times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly.If necessary, dose Epostima® is adjusted upwards or downwards every 3-4 weeks. If after 4 weeks the hemoglobin level rises by 10 g / l, the treatment is continued at the previous dose. If after 4 weeks the hemoglobin rises less than 10 g / L, an increase in the dose to 300 IU / kg 3 times a week is possible. If after 8 weeks of therapy with Epostim® the hemoglobin level did not increase by at least 10 g / l, the development of the effect is unlikely, the drug should be discontinued.
If the hemoglobin level increases by more than 20 g / l for 4 weeks of therapy, the dose of Epostim® should be reduced by a factor of 2. If the hemoglobin level exceeds 140 g / L, Epostim® treatment is suspended until the hemoglobin level drops to <130 g / L, after which the therapy continues at a dose equal to 50% of that at which the therapy was suspended.
With chronic lymphocytic leukemia, Epostim® treatment continues for up to 4 weeks after the end of chemotherapy. The maximum dose should not exceed 300 IU / kg 3 times a week.
Treatment should be resumed only if the most likely cause of anemia is insufficient production of endogenous erythropoietin.
Prevention and treatment of anemia in patients with rheumatoid arthritis: Have patients with rheumatoid arthritis, the synthesis of endogenous erythropoietin is suppressed under the influence of an increased concentration of pro-inflammatory cytokines. Treatment of anemia in these patients is carried out by Epostim® with subcutaneous administration at a dose of 50-75 IU / kg 3 times a week. With an increase in hemoglobin content of less than 10 g / L after 4 weeks of treatment, Epostim® dose is increased to 150-200 IU / kg 3 times a week. Further increase in the dose seems inappropriate.
Treatment and prevention of anemia in premature infants, born with low body weight: For the prevention and treatment of anemia in preterm infants, the administration of Epostima® should begin as early as possible, preferably from the 3rd day of life at a dose of 200 IU / kg body weight intravenously or subcutaneously 3 times a week and last no more than 6 weeks. The effect of the drug in preterm neonates who have already undergone blood transfusion is slightly less than those who did not undergo blood transfusion.
Preparation of patients for surgical interventions with a planned large blood loss: The recommended dose of Epostim® is 450-600 IU / kg once a week sc for 3 weeks prior surgery (21, 14 and 7 days before surgery) and on the day of surgery. When the need to shorten the period of preoperative preparation, it is possible to apply Epostim® in a dose of 300 IU / kg subcutaneously daily 10 days before the operation, on the day of the operation and 4 days after the operation.
If the level of hemoglobin in the preoperative period >150 g / l, the use of Epostim® should be discontinued.
All patients should receive oral iron preparations at a dose of 200 mg / day throughout the course of treatment. If possible, additional oral administration of iron preparations should be provided prior to the initiation of Epostim® therapy to create a depot of iron in the patient's body.