In 1 ml of a solution of the drug Epocrine may contain 1000 IU, 2000 IU, 10 000 IU or 4000 IU alpha epoetin (human recombinant erythropoietin)
Additional substances: penta sodium citrate sesquihydrate or sodium citrate dihydrate, albumin, sodium chloride, water, citric acid monohydrate.
Epocrine is a clear, colorless solution for parenteral administration.
1 ml of solution in a glass ampoule; ten ampoules in contour packaging; one pack in a pack of paper.
Pharmacodynamics and pharmacokinetics
Process stimulator erythropoiesis, human recombinant erythropoietin, glycoprotein.
Activates division and maturation red blood cells from stem cells of an erythrocyte sprout. Recombinant Epoetinproduced in genetically modified mammalian cells. In composition, immunological and biological characteristics recombinant alpha epoetin identical to natural erythropoietinperson. Its use leads to an increase in the content hemoglobin and increase hematocritimproving tissue perfusion and heart function.
The most powerful effect of using epoetin alpha detected when anemiaagainst a background of chronic renal failure.
Very rarely, with prolonged use of the drug to treat anemic conditions, the formation of antibodies to erythropoietin from red cell partial aplasia or isolated education antibodies.
After subcutaneous administration, the concentration of the active substance increases in blood slowly, the highest concentration is reached after 12-17 hours. Bioavailability values approach 26-40%.
After subcutaneous administration, the half-life is 16-23 hours, and after intravenous administration, it is 5-6 hours.
Indications for use
- Prevention and treatment anemia in persons with solid tumorsprovoked by anticancer therapy.
- Anemiain persons with chronic renal failure.
- Prevention and treatment anemiaarising from the use of Zidovudine at HIV infected.
- Prevention and treatment anemiain persons with rheumatoid arthritis, myeloma, low-grade non-Hodgkin lymphomas, chronic lymphocytic leukemia.
- Prevention and treatment anemiain premature babies weighing up to 1500 grams.
- To reduce the amount of transfused blood during major surgeries or acute blood loss.
- Particular red cell aplasiaprovoked by previous treatment with drugs erythropoietin.
- Poorly controlled arterial hypertension.
- The inability to adequately conduct anticoagulant therapy.
- Unstable angina pectoris.
- Gap for 30 days after myocardial infarction.
- Increased risk of occurrence thromboembolism and deep vein thrombosis when collecting blood before surgery.
- Hypersensitivityto the components of the drug.
It is recommended to use Epocrine with caution in patients with malignant neoplasms, from sickle cell type anemiawith moderate anemiano shortage gland, from epilepsy, from refractory anemia from thrombosis, with chronic liver failure.
- Flu-like symptoms: drowsiness, dizziness, myalgia, headache, arthralgia, fever.
- Disorders from blood circulation: dose dependent arterial hypertension, hypertensive crisissudden increase in pressure with symptoms encephalopathy and generalized tonic-clonic seizures.
- Disorders from metabolism: decrease in content ferritinin serum, a decrease in serum metabolic rates glandin persons with uremia not excluded hyperphosphatemia and hyperkalemia
- Allergic reactions: hives, skin rash, eczema, angioedema, itching.
- Local reactions: redness, burning, pain in the injection area.
- Other reactions: thrombocytosis, shunt thrombosis, respiratory failure, education antibodies to erythropoietin with the advent red cell partial aplasia or isolated education antibodiesaggravation porphyria.
Instructions for use Epocrine (Method and dosage)
Instructions for use Epocrine permits subcutaneous and intravenous routes of administration of the drug.
In the treatment of anemia in individuals with chronic renal failure the drug is administered intravenously or subcutaneously; persons on hemodialysis - through arteriovenous shunt at the end dialysis. When changing the method of administration, the drug is administered in the same dose, then it is adjusted if necessary (with subcutaneous injection, to achieve an identical therapeutic effect, the dose of the drug is 20-30% less than with intravenous injection). Epocrine therapy consists of two stages.
At the first stage, correction of changes in laboratory parameters is performed. When administered subcutaneously, the initial dose is 30 IU / kg three times a week. With the introduction of the drug intravenously, the initial dose is 50 IU / kg per week. The correction period ends when concentration is reached. hemoglobin 100-119 g / l in adult patients or 95-109 g / l in pediatric patients and values hematocrit in 30-35%. These indicators should be monitored weekly.
During treatment, the following situations may occur:
- an increase in hematocrit by 0.5-1% weekly; in such a situation, the dose is not changed until the targets are reached;
- value growth rate hematocrit less than 0.5% per week; in this case, a single dose is increased one and a half times;
- increase in value hematocrit over 1% weekly; it is necessary to reduce a single dose by one and a half times;
- if hematocrit remains at the same level or decreases; it is recommended to analyze the possible causes of such resistance.
In the second stage, maintenance therapy is performed. To save values hematocrit in 30-35%, the dosage used in the previous step should be reduced by one and a half times. Subsequently, the maintenance dose is selected individually, taking into account the dynamics of change hematocrit and hemoglobin. When the stabilization of hematological parameters occurs, the transition to the administration of the drug is allowed once every one or two weeks.
For prevention and treatment anemia in individuals with solid tumors Before using the drug, it is recommended to determine the value endogenous erythropoietin. If the concentration erythropoietin serum less than 200 IU / ml, then the initial dose of Epocrine when administered intravenously is 150 IU / kg, and when administered subcutaneously, it can be reduced to 100 IU / kg. If there is no response to treatment, then a dosage increase of up to 300 IU / kg is allowed. A further increase in dosage seems inappropriate. It is forbidden to prescribe epocrine in patients with concentration endogenous erythropoietin over 200 IU / ml.
For prevention and treatment anemia provoked by the use of zidovudine in patients with HIV infection, the appointment of the drug at a rate of 100-150 IU / kg three times a week intravenously is effective if the content endogenous erythropoietin not higher than 500 IU / ml, and the dose taken Zidovudine amounts to 4.2 g per week. When administered subcutaneously, the dose can be reduced by one and a half times.
Using Epocrine for Prevention and Treatment anemia in people with myeloma, chronic lymphocytic leukemia, low-grade non-Hodgkin’s lymphomascaused by inadequate biosynthesis endogenous erythropoietin. When keeping hemoglobinnot higher than 100 g / l, and erythropoietin serum up to 100 IU / ml, the drug is administered at an initial dose of 100 IU / kg subcutaneously three times a week. Hemodynamic data are monitored weekly. If necessary, the dose is adjusted every 3-4 weeks. If the weekly dose of 600 IU / kg does not increase the level hemoglobin, then Epocrine must be canceled, because its further administration is ineffective.
The use of the drug for the prevention and treatment anemia in patients with rheumatoid arthritis due to the fact that in this disease biosynthesis is suppressed endogenous erythropoietin by pro-inflammatory cytokines. The drug is administered at a dose of 50-75 IU / kg three times a week subcutaneously. With an increase in hemoglobin content more slowly than 10 g / l for four weeks of therapy, the dosage of the drug is increased to 150-200 IU / kg while maintaining the frequency of administration. A larger dose increase is impractical.
For prevention and therapy anemia in preterm infants weighing up to 1500 gramsthe drug is prescribed at a dose of 200 IU / kg subcutaneously three times a week, from the sixth day of life and continues until the desired indicators are achieved, but not longer than 6 weeks.
For warning anemia in major surgeries and acute blood lossthe drug is administered three times a week intravenously or subcutaneously at 100-150 IU / kg until the required level is reached hematocrit and hemoglobin.
Signs of an overdose: may increase the adverse effects described in the section "Side effects".
Overdose treatment: with increasing pressure antihypertensive agents, and with their low effectiveness, the drug Epocrine is canceled. At high content hemoglobinand level hematocrit is produced bloodletting.
When combined with Cyclosporine its binding to red blood cellsmay cause a need for dose adjustment Cyclosporin.
To prevent possible incompatibility or a decrease in the activity of Epocrine, it is forbidden to mix with solutions of other drugs.
Terms of sale
Keep out of the reach of children. Store at 2-8 ° C.
Do not forget about the possibility of increasing pressure at the beginning of therapy. The dose of Epocrine should not be higher than the dose recombinant erythropoietinused in the previous course of therapy. During the first 2 weeks, the dose is not changed, evaluating the response to treatment. Then the dose is allowed to decrease or increase according to the scheme above.
During therapy, weekly monitoring of blood pressure and blood counts, including hematocritcontent platelet count and ferritin. In persons with uremiapassing hemodialysisdue to the increase hematocritit is often necessary to increase the dosage Heparinaas well as timely prevention thrombosisand revision of the shunt in the early postoperative period.
In the pre - and postoperative period, the content hemoglobin should be monitored more often if its initial value was less than 140 g / l.
In persons with controlled arterial hypertension or with thrombotic complicationsin some cases, an increase in dosage is required anticoagulantand antihypertensive drugs. When hypertensive crisisemergency treatment is needed, and therapy Epoetin Alpha temporarily canceled.
We cannot exclude the effect of the drug on the growth of certain types of tumors, for example, bone marrow tumors.
In patients with uremia treatment anemia this drug may cause increased appetite and increased absorption potassiumand proteins. Because of this, a correction may be required. hemodialysis to maintain the right content creatinine urea and potassium.
Before establishing the required maintenance dose for people with uremiaIt is recommended to avoid driving.
AnalogsMatches for ATX Level 4 code:EpobiocrineRecormonErythropoietin
Analogs of Epocrine: Eprex, Rus-GF, Binokrit, Rus toxicodendron, Aerin, Rus-plus, Epocomb, Repoetin-SP, Eralfon.
Epocrine is an approved remedy for use in children of all ages.
During pregnancy and lactation
It is possible to use the drug in these periods if there is evidence and taking into account all possible risks.
Reviews about Epocrine
According to reviews, Epocrine (and similar drugs) is an indispensable tool in the treatment of anemia in difficult clinical situations. The development of side effects and the appearance antibodies on erythropoietinare very rare. The drug is expensive.
Epocrine price, where to buy
The price of Epocrine 2000 IU in Russia is 3700-4400 rubles. For price comparison, to buy a 1000 IU drug package in Krasnoyarsk and buy Epocrine 1000 in Moscow will cost 2900-3000 rubles.
In Ukraine, the price of a package of medicine 2000 IU can reach 2700 hryvnia.