Intravenous administration. The duration of the injection is at least 1-5 minutes. Slower administration is preferable for patients who have an influenza-like syndrome for drug administration.Patients who are on hemodialysis, the drug is injected through the needle into the fistula at the end of the dialysis procedure. 10 ml of a 0.9% solution of sodium chloride are injected into the circulation system to flush the connecting tubes, and also to ensure a satisfactory administration of the preparation to the circulation system after injection of the Aéprin® preparation.
It is forbidden to administer the drug as an intravenous infusion or to mix it with other medications.
Subcutaneous injections. The maximum volume of one subcutaneous injection should not exceed 1 ml, if it is necessary to introduce large volumes, several injection points should be used. The drug is injected under the skin of the shoulder, thigh, anterior abdominal wall.
When the mode of administration is changed, the drug is administered in the previous dose, then the dose is adjusted if necessary (to achieve the same therapeutic effect with subcutaneous administration, a 20-30% dose is required less than with intravenous administration).
Patients with chronic renal insufficiency.
Have patients with chronic renal insufficiency AEPRIN® can be used intravenously and subcutaneously.Intravenous administration of the drug is preferred for patients on hemodialysis. In patients with chronic renal failure who are not receiving dialysis, and in patients on peritoneal dialysis, the drug can be administered subcutaneously. The optimal content of hemoglobin for adult patients is 100-120 g / l, for children - 95-110 g / l.
If patients have concomitant clinically severe ischemic heart disease or chronic heart failure, the hemoglobin content maintained should not exceed the upper limit of the optimal value.
The dose of the drug is 50 IU / kg body weight. In the process of selection, the dose of Aéprin® is increased if the hemoglobin content rises by less than 10 g / l per month.
Adult patients on hemodialysise.
In patients on hemodialysis, AEPRIN® is preferably administered intravenously.
Treatment is divided into two phases - the phase of anemia correction and the supporting phase.
Anemia correction phase:
Aeprin® is administered at a rate of 50 IU / kg body weight three times a week. If necessary, the dose can be increased (no more than once every 4 weeks) by 25 IU / kg body weight three times a week until the optimal hemoglobin content is reached. Supportive therapy:
The usual dose for maintaining the optimal hemoglobin content is 30-100 IU / kg body weight three times a week. The available data suggest that patients with severe anemia (hemoglobin content less than 60 g / l) require a large maintenance dose.
Adult patients on peritoneal dialysis.
Have patients on peritoneal dialysis Both intravenous and subcutaneous administration of AEprin® is possible.
Anemia correction phase:
The drug is administered at a rate of 50 IU / kg body weight twice a week. If necessary, the dose can be gradually increased by 25 IU / kg body weight (no more often than once every 4 weeks) twice a week until the optimal hemoglobin content is reached.
Support phase:
The usual dose for maintaining optimal hemoglobin is 25-50 IU / kg body weight twice a week.
Adult patients with chronic renal failure who are not receiving dialysis. In patients with chronic renal failure who are not receiving dialysis, Both intravenous and subcutaneous administration of AEprin® is possible.
Anemia correction phase:
Aeprin® is administered at a rate of 50 IU / kg body weight three times a week. If necessary, the dose can be increased (no more than once every 4 weeks) by 25 IU / kg body weight three times a week until the optimal hemoglobin content is reached. Support phase:
The usual dose for maintaining the optimal hemoglobin content is from 17 to 33 IU / kg body weight three times a week.
Children who are on hemodialysis, regardless of age.
Anemia correction phase:
AEprin® is administered at a rate of 50 IU / kg body weight three times a week intravenously.
If necessary, the dose can be increased (no more than once every 4 weeks) by 25 IU / kg body weight three times a week until the optimal hemoglobin content is reached.
Support phase:
Usually, children with a body weight of up to 30 kg require a larger maintenance dose than adults and children weighing more than 30 kg. In clinical trials after a six-month therapy with AEprin®, the following maintenance doses of epoetin alfa were established:
| Body weight, kg | Dose of the drug, IU / kg body weight three times a week |
| Normal support | Median |
| <10 | 75-150 | 100 |
| 10-30 | 60-150 | 75 |
| >30 | 30-100 | 33 |
The available data suggest that patients with severe anemia (hemoglobin less than 68 g / L) require a larger maintenance dose than patients with less severe anemia.
Patients with non-myeloid tumors
To treat anemia in patients with non-myeloid tumors, Aéprin® is introduced subcutaneously. The optimal hemoglobin content should be 120 g / l. AEprin® may be administered to patients with symptomatic anemia, for the prevention of anemia in patients receiving chemotherapy and having an initial low hemoglobin content during the first course of chemotherapy (for example, a decrease in hemoglobin content by 10-20 g / L at a baseline of 110-130 g / L or decrease by more than 20 g / l with an initial hemoglobin content of more than 130 g / l).
The initial dose for the prevention or treatment of anemia should be 150 IU / kg body weight three times per week subcutaneously. Alternatively, the initial dose may be 450 IU / kg body weight once a week, subcutaneously. If, after four weeks of treatment, hemoglobin has increased and is at least 10 r/ l, or the number of reticulocytes increased by more than 40,000 cells / μl higher than the original, the dose of Aéprin® remains the same - 150 IU / kg body weight three times a week or 450 IU / kg body weight once a week. If, after four weeks of treatment, an increase in hemoglobin is less than 10 g / L and an increase in the number of reticulocytes is less than 40,000 cells / μl compared to the initial,then within the next four weeks the dose is increased to 300 IU / kg body weight three times a week. If after an additional four weeks of treatment with a dose of AEprin® 300 IU / kg body weight three times a week, hemoglobin rose to at least 10 g / l or the amount of reticulocytes increased by more than 40,000 cells / μl, then maintain the existing dose of the drug Aeprin ® (300 IU / kg body weight 3 times a week). If, after four weeks of treatment at a dose of 300 IU / kg body weight, the hemoglobin rises by less than 10 g / l and the increase in the number of reticulocytes is less than 40,000 cells / μl compared to the original, treatment should be discontinued.
If the hemoglobin is increased by more than 20 g / l within a month or hemoglobin reaches 120 g / l, the dose of the drug should be reduced by 25%. If the hemoglobin exceeds 130 g / l, it is necessary to suspend the treatment until it falls below 120 g / l and then continue the injection of the drug AEprin ® at a dose 25% lower than the original.
Therapy with Aéprin® should continue for one month after the end of the course of chemotherapy.
The serum ferritin content (or serum iron concentration) should be determined in all patients before and during the treatment with Aéprin®.If necessary, an additional iron intake is prescribed.
HIV-infected patients receiving zidovudine therapy
It is recommended that the initial concentration of endogenous erythropoietin in the blood serum be determined before starting treatment with the drug AEprin®. The conducted studies show that with the concentration of erythropoietin more than 500 IU / ml, the effect of therapy with AEprin® is unlikely.
Phase correction of anemia: the drug is prescribed at a dose of 100 IU / kg body weight three times a week subcutaneously or intravenously for eight weeks. If after eight weeks of therapy failed to achieve a satisfactory effect (for example, reduce the need for blood transfusions or achieve an increase in hemoglobin), the dose may gradually increase (not more than once every 4 weeks) by 50-100 IU / kg body weight three times in Week. If the satisfactory effect of therapy with AEprin® at a dose of 300 IU / kg body weight three times a week is not achieved, then the response to further therapy at higher doses is unlikely.
Supporting phase: After achieving a satisfactory effect in the phase of correction of anemia,the maintenance dose should provide hematocrit within 30-35%, depending on the change in the dose of zidovudine, the presence of concomitant infectious or inflammatory diseases. With a hematocrit of more than 40%, the injection of Aéprin® should be discontinued before the hematocrit is reduced to 36%. When resuming therapy, the dose of epoetin alfa should be reduced by 25% with subsequent correction to maintain the required hematocrit.
The serum ferritin content (or serum iron concentration) should be determined in all patients before and during the treatment with Aéprin®. If necessary, an additional iron intake is prescribed.
Adult patients participating in the autologous blood collection program before surgical interventions
It is recommended to use the intravenous route of drug administration. Epoetin alfa should be administered at the end of the blood collection procedure. Before prescribing AEPRIN®, all contraindications to collection of autologous blood should be taken into account. Before surgery, AEPRIN® should be administered twice a week for three weeks.At each visit to the doctor, the patient receives a blood sample (if the hematocrit is> 33% and / or hemoglobin> 110 g / l) and stored for autologous transfusion. The recommended dose of Aéprin® is 600 IU / kg body weight intravenously twice a week.
The serum ferritin content (or serum iron concentration) should be determined in all patients before and during the treatment with Aéprin®. If necessary, an additional iron intake is prescribed.
In the presence of anemia, its cause should be established before the initiation of therapy with Aéprin®. It is necessary to provide an adequate intake of iron in the body as soon as possible, appointing an iron preparation at a dose of 200 mg / day orally (based on elemental iron) and maintaining iron intake at this value throughout the course of therapy.
Patients in the pre- and postoperative period, not participating in the program of collection of autologous blood
It is recommended that subcutaneous route of administration of the drug at a dose of 600 IU / kg of body weight per week for three weeks preceding surgery (21, 14 and 7 days before surgery) and on the day of surgery.If necessary, when the preoperative period needs to be reduced for medical reasons, AEprin® can be administered daily at a dose of 300 IU / kg body weight for 10 days before surgery, on the day of surgery and for 4 days after surgery. If hemoglobin in the pre-operative period reaches 150 g / l and above, the use of epoetin alfa should be discontinued.
Before starting epoetin alfa therapy, you need to make sure that the patients do not have iron deficiency.
All patients should receive an adequate amount of iron (200 mg / day orally in terms of elemental iron) throughout the course of treatment. If possible, additional iron intake should be provided orally prior to the initiation of therapy with Aéprin® to provide an adequate iron depot in the patient's body.