Description
Latin name
ERALFON
Packing
6 syringes.
Pharmacological action
Epoetin alpha – a glycoprotein that specifically stimulates erythropoiesis, activates mitosis and the maturation of red blood cells from red blood cell progenitors. Recombinant epoetin alpha is synthesized in mammalian cells into which a gene encoding human erythropoietin is inserted. In composition, biological and immunological properties of epoetin alfa are identical to natural human erythropoietin. The administration of epoetin alpha leads to an increase in hemoglobin and hematocrit levels, and an improvement in the blood supply to tissues and heart function. The most pronounced effect of the use of epoetin alfa is observed in anemia caused by chronic renal failure. In very rare cases, with prolonged use of erythropoietin for the treatment of anemic conditions, the formation of neutralizing antibodies to erythropoietin with or without partial red cell aplasia may be observed.
Indications
anemia in patients with chronic renal failure, including hemodialysis
prophylaxis and treatment of anemia in patients with solid tumors whose anemia is a consequence of antitumor therapy
prophylaxis and treatment of anemia in patients infected with human immunodeficiency virus (HIV) caused by the use of zidovudine, at an endogenous erythropoietin level of less than 500 IU / ml
, the prevention and treatment of anemia in patients with myeloma, non-Hodgkin ² ¢s lymphomas of low malignancy, chronic lymphocytic leukemia, rheumatoid arthritis
treatment and prevention of anemia in premature babies born with low body weight (up to 1.5 kg)
as part of the pre-deposit program before extensive surgery in patients with a hematocrit level of 33 ² 39%, to facilitate the collection of autologous blood and reduce the risk associated with the use of llogennyh transfusions if the anticipated need for transfused blood exceeds the number that can be obtained by collecting autologous without epoetin alfa
prior to major surgery with the expected blood loss 900-1800 ml in adults, without anemia or with mild to moderate anemia (hemoglobin level 100 ² 130 g / l), to reduce the need for allogeneic blood transfusions and to facilitate the restoration of erythropoiesis.
Contraindications
hypersensitivity to the drug Eralfon or its components
partial red cell aplasia after previous treatment with any erythropoietin
uncontrolled arterial hypertension
inability to conduct adequate anticoagulant ocular disease, severe coronary artery disease including acute and recent myocardial infarction and acute cerebrovascular accident (as part of deposit program of blood collection prior to surgery).
Precautions: malignant neoplasms epileptic syndrome, incl. a history of thrombocytosis, thrombosis (history) sickle cell anemia iron-, B12- or folio-deficient states of porphyria chronic liver failure.
Use during pregnancy and lactation
Due to the fact that there is insufficient experience with the use of erythropoietin during pregnancy and lactation in humans, epoetin alpha should be prescribed only if if the expected benefits of its use exceed the possible risk to the fetus and mother. It is not known whether epoetin alfa is excreted in breast milk.
Composition
1 syringe (0.5 ml) contains: active substance: epoetin alpha (REPOETIN-SP – recombinant human erythropoietin) 2000 IU,
excipients: albumin solution in terms of dry albumin – 1 mg sodium citrate pentasequigid 2 mg , 32 mg or sodium citrate dihydrate – 1.9104 mg sodium chloride – 2.336 mg of citric acid monohydrate – 0.0228 mg water for injection – up to 0.4 ml.
Dosage and administration of
Treatment of anemia in patients with chronic renal failure
Adults on hemodialysis. Eralfon is administered subcutaneously or intravenously at the end of the dialysis session. When the method of administration is changed, the drug is administered in the previous dose, then the dose is adjusted if necessary (with a subcutaneous method of drug administration, a dose of 20-30% is required to achieve the same therapeutic effect than when administered intravenously). Treatment with the drug includes two stages.
1. Correction stage: with subcutaneous administration of the drug, the initial single dose is 30 IU / kg 3 times a week. With intravenous administration of the drug, the initial single dose is 50 IU / kg 3 times a week. The correction period lasts until the optimal hemoglobin level (100 120 g / l in adults and 95 110 g / l in children) and hematocrit (30 35%) are reached. These indicators must be monitored weekly.
The following situations are possible:
– the hematocrit rises from 0.5 to 1% per week. In this case, the dose is not changed until optimal
values are achieved – the hematocrit growth rate is less than 0.5% per week. In this case, a single dose increase of 1.5 times
is necessary – the growth rate is more than 1% per week. In this case, it is necessary to reduce the single dose of the drug by 1.5 times
– the hematocrit remains low or decreases. It is necessary to analyze the causes of resistance before increasing the dose of the drug.
The effectiveness of therapy depends on a properly selected individual treatment regimen.
2. Stage of maintenance therapy: to maintain hematocrit at a level of 30 35%, the dose of the drug used at the stage of correction should be reduced by 1.5 times. Then, the maintenance dose of the drug is selected individually, taking into account the dynamics of hematocrit and hemoglobin levels.
Children on hemodialysis. The initial dose is 50 U / kg 3 times a week. If necessary, a single dose is increased 1 time in 4 weeks by 25 IU / kg to achieve the optimal hemoglobin concentration. The maintenance dose in children weighing less than 10 kg is 75 150 PIECES / kg (on average 100 PIECES / kg) 3 times a week 10-30 kg – 60 150 PIECES / kg (on average 75 PIECES / kg) 3 times per week more than 30 kg – 30 100 U / kg (average 33 U / kg) 3 times a week.
Adult predialysis patients. The initial dose is administered subcutaneously or intravenously 3 times at 50 units / kg per week. If necessary, a single dose is increased 1 time in 4 weeks by 25 units / kg until the optimal hemoglobin concentration is achieved. The maintenance dose is 17 33 units / kg 3 times a week.
Prevention and treatment of anemia in patients with solid tumors
Before starting treatment, it is recommended to determine the level of endogenous erythropoietin. When the concentration of serum erythropoietin is less than 200 IU / ml, the initial dose of the drug is 150 IU / kg 3 times a week with the intravenous route of administration. If after 4 weeks of treatment the hemoglobin level rises and is at least 10 g / l or the number of reticulocytes has increased by more than 40,000 cells / μl above the initial level, then the dose of the drug remains the same (150 IU / kg 3 times a week).
If, after 4 weeks of treatment, the increase in hemoglobin level is less than 10 g / l and the increase in the number of reticulocytes is less than 40,000 cells / μl compared to the initial level, then over the next 4 weeks the dose is increased to 300 IU / kg 3 times a week. If after an additional 4 weeks of treatment at a dose of 300 IU / kg, the hemoglobin level has increased and is at least 10 g / l or the number of reticulocytes increases by more than 40,000 cells / μl, then the existing dose of the drug (300 IU / kg 3 times a week is maintained ) If after 4 weeks of treatment at a dose of 300 IU / kg, the hemoglobin level has increased by less than 10 g / l and the increase in the number of reticulocytes is less than 40,000 cells / μl compared to the initial level, treatment should be discontinued. In the case of an increase in hemoglobin more than 20 g / l for a month, the dose of the drug must be reduced by 25%. If the hemoglobin level exceeds 140 g / l, it is necessary to suspend treatment until the hemoglobin level drops below 120 g / l and then continue to administer the drug at a dose 25% lower than the original.
Therapy with the drug should continue for 1 month after the end of the course of chemotherapy.
Serum ferritin level (or serum iron level) must be determined in all patients before and during treatment with the drug. If necessary, an additional intake of iron is prescribed.
Prevention and treatment of anemia in patients with HIV infection
It is recommended to determine the initial level of endogenous erythropoietin in the blood serum before starting treatment with Eralfon. Studies show that at an erythropoietin level of more than 500 IU / ml, the effect of drug therapy is unlikely.
Treatment with the drug includes 2 stages.
1. Correction stage: the drug is prescribed at a dose of 100 IU / kg 3 times a week subcutaneously or intravenously for 8 weeks. If after 8 weeks of therapy it was not possible to achieve a satisfactory effect (for example, to reduce the need for blood transfusions or to increase the level of hemoglobin), the dose can gradually increase (not more than 1 time in 4 weeks) by 50-100 IU / kg 3 times a week. If it was not possible to achieve a satisfactory effect of therapy with the drug Eralfon at a dose of 300 IU / kg 3 times a week, then a response to further therapy at higher doses is unlikely.
2. Stage of maintenance therapy: after achieving a satisfactory effect in the phase of correction of anemia, the maintenance dose should provide a hematocrit level of 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%, administration of the drug should be stopped until the hematocrit decreases to 36%. When resuming therapy, the dose of epoetin alpha should be reduced by 25%, followed by adjustment to maintain the required level of hematocrit. Serum ferritin level (or serum iron level) must be determined in all patients before and during treatment with the drug. If necessary, an additional intake of iron is prescribed.
Prevention and treatment of anemia in patients with myeloma, non-Hodgkin s lymphomas of low malignancy and chronic lymphoid leukemia
In these patients, the feasibility of treatment with epoetin alfa is due to inadequate synthesis of endogenous erythropoietin against the background of the development of anemia. At a hemoglobin level below 100 g / l and serum erythropoietin below 100 IU / ml, Eralfon is administered subcutaneously at a starting dose of 100 IU / kg 3 times a week. Laboratory monitoring of hemodynamic parameters is carried out weekly. If necessary, the dose is adjusted in the direction of increase or decrease every 3-4 weeks. If, upon reaching a weekly dose of 600 IU / kg, an increase in hemoglobin level is not observed, further use of epoetin alpha should be discontinued as ineffective.
Prevention and treatment of anemia in patients with rheumatoid arthritis
In patients with rheumatoid arthritis, suppression of the synthesis of endogenous erythropoietin is observed under the influence of an increased concentration of pro-inflammatory cytokines. Treatment of anemia in these patients is carried out with the drug with subcutaneous administration at a dose of 50 75 IU / kg 3 times a week. With an increase in hemoglobin level of less than 10 g / l after 4 weeks of treatment, the dose of the drug is increased to 150-200 IU / kg 3 times a week. A further increase in dose seems inappropriate.
Treatment and prevention of anemia in premature babies born with low body weight
Eralfon is administered subcutaneously at a dose of 200 IU / kg 3 times a week, starting from the 6th day of life until the target levels of hemoglobin and hematocrit are reached, but not more than 6 weeks .
Adult patients, participating in an autologous blood collection program before
surgical interventions. It is recommended to use the intravenous route of administration of the drug. Epoetin alfa should be administered at the end of the blood collection procedure.
Before prescribing the drug, all contraindications to the collection of autologous blood should be considered. Before surgery, Eralfon should be prescribed 2 times a week for 3 weeks. At each visit to the doctor, a portion of blood is taken from the patient (if hematocrit? 33% and / or hemoglobin level? 110 g / l) and stored for autologous transfusion. The recommended dose of Eralfon is 600 IU / kg iv twice a week.
Serum ferritin level (or serum iron level) must be determined in all patients before and during treatment with the drug. If necessary, an additional intake of iron is prescribed.
If anemia is present, its cause must be established before starting epoetin alfa therapy. It is necessary to ensure an adequate intake of iron in the body as soon as possible by administering an iron preparation orally at a dose of 200 mg / day (based on ferrous iron), and to maintain the intake of iron at this level throughout the course of therapy.
Patients in the pre- and postoperative period not participating in the autologous blood collection program
It is recommended to use subcutaneous administration of the drug at a dose of 600 IU / kg per week for 3 weeks prior to surgery (days 21, 14 and 7 before surgery), and on the day of surgery. If necessary, when it is medically necessary to shorten the preoperative period, Eralfon can be prescribed daily at a dose of 300 IU / kg for 10 days before surgery, on the day of surgery and within 4 days after surgery. If the hemoglobin level in the preoperative period reaches 150 g / l and higher, the use of epoetin alpha should be discontinued. Before starting therapy with epoetin alfa, it is necessary to ensure that patients do not have iron deficiency.
All patients should receive an adequate amount of iron (orally 200 mg / day based on ferrous iron) throughout the course of treatment. If possible, an additional oral intake of iron should be provided before the start of epoetin alpha therapy to ensure an adequate iron depot in the patient’s body.
Side effects
At the beginning of treatment, flu-like symptoms may occur: dizziness, drowsiness, fever, headache, myalgia, arthralgia.
From the CCC side: dose-dependent increase in blood pressure, worsening of hypertension (most often in patients with chronic renal failure), in some cases – a hypertensive crisis, a sharp increase in blood pressure with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic seizures.
From the hemopoietic organs: thrombocytosis, in some cases – shunt or arteriovenous fistula thrombosis (including patients on hemodialysis with a tendency to hypotension or with aneurysm, stenosis), erythrocyte germ aplasia.
Allergic reactions: skin rash (mild or moderate), eczema, urticaria, pruritus, angioedema.
Local reactions: hyperemia, burning, mild or moderate soreness at the injection site (more often with s / c administration).
From the laboratory side: a decrease in the concentration of ferritin in the serum, with uremia – hyperkalemia, hyperphosphatemia.
Other: complications, associated with respiratory failure or with a decrease in blood pressure, immune reactions (induction of antibody formation), exacerbation of porphyria.
Drug Interaction
Decreases the concentration of cyclosporine due to an increase in its binding to erythrocytes (the dose of cyclosporine may need to be adjusted).
Pharmaceutically incompatible with solutions of other drugs.
Overdose
Symptoms: increased side effects.
Treatment: symptomatic. At high level Hb – bloodletting.
Storage conditions
At 2 8 ° C.
Keep out of the reach of children.
Expiration
3 Year
Active ingredient
epoetin alfa
Pharmacy terms of sale
Prescription
