Recormon
Recormon: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. In case of impaired renal function
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Recormon®
ATX code: B03XA01
Active ingredient: Epoetin beta
Manufacturer: F. Hoffmann-La Roche Ltd. (Switzerland), Roche Diagnostics (Germany)
Description and photo update: 2019-07-08
Prices in pharmacies: from 5590 rubles.
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Recormon is a drug with erythropoietic and hematopoietic effects.
Release form and composition
Dosage forms of release:
- Lyophilized powder for solution for injection: white, homogeneous; solvent - transparent, colorless; prepared solution - colorless, transparent or slightly opalescent (in vials, 5 vials in plastic trays, complete with solvent (in ampoules, 5 pcs.), 2 trays in a cardboard box);
- Lyophilisate for preparation of a solution for subcutaneous administration: homogeneous powder or porous mass of almost white or white color; solvent - colorless, transparent; prepared solution - colorless, transparent or slightly opalescent (in two-section cartridges for syringe-pens "Reco-Pen": in one section - lyophilisate, in the other - a solvent of 1 ml, 1 or 3 cartridges in a cardboard box);
- Solution for injection (intravenous and subcutaneous injection): colorless, transparent or slightly opalescent (1000/2000 IU each: in syringe tubes of 0.3 ml, 3 syringe tubes each in blisters, complete with needles for injections, each 2 packages in a cardboard box; 10,000 / 20,000 / 30,000 IU each: in syringe tubes of 0.6 ml, 3 syringe tubes in blister packs, complete with needles for injection, 2 each (10,000 / 20,000 IU) or 1 or 4 (30,000 IU) packages in a cardboard box.
The composition of 1 bottle with lyophilisate includes:
- Active ingredient: epoetin beta - 1000, 2000 or 5000 IU;
- Additional components: urea, L-leucine, L-threonine, L-phenylalanine, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, L-glutamic acid, L-isoleucine, glycine.
Solvent: water for injection - 1 ml.
The composition of 1 cartridge with lyophilisate includes:
- Active ingredient: epoetin beta - 10,000 or 20,000 IU;
- Additional components: urea, L-isoleucine, L-leucine, L-threonine, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, L-glutamic acid, L-phenylalanine, glycine.
Solvent: benzyl alcohol, benzalkonium chloride, water for injection.
The composition of 1 syringe tube of injection solution includes:
- Active ingredient: epoetin beta - 1000, 2000, 10,000, 20,000 or 30,000 IU;
- Additional components: urea, sodium chloride, L-leucine, L-threonine, L-phenylalanine, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-isoleucine, L-glutamic acid, water for injection.
Pharmacological properties
Pharmacodynamics
The active component of Recormon is epoetin beta - a glycoprotein containing 165 amino acids. It belongs to mitogenic factors and hormones of differentiation, promoting the synthesis of erythrocytes from partially determined erythropoietic progenitor cells.
Recombinant epoetin beta, reproduced by genetic engineering, has an amino acid and carbohydrate composition that is completely identical to human erythropoietin.
When administered intravenously and subcutaneously, epoetin beta increases the number of reticulocytes and erythrocytes, and also increases the level of hemoglobin and the rate of incorporation of iron (59 Fe) into cells. In this case, a specific stimulation of erythropoiesis occurs without affecting leukopoiesis. The cytotoxic effect of epoetin beta on human skin cells or bone marrow has not been identified.
In some cases, erythropoietin receptors are present in the membrane of tumor cells. Researchers assume that stimulation of erythropoiesis by the drug can provoke the growth of malignant tumors. Recormon is used for subcutaneous and intravenous administration, since epoetin beta is destroyed in the gastrointestinal tract.
Pharmacokinetics
When the drug is administered subcutaneously to patients with uremia, its active component is absorbed for a long time, which provides a plateau of serum epoetin beta concentration. The maximum concentration of the substance in the blood is reached within 12–28 hours.
The bioavailability of the active component of Recormon when administered subcutaneously is 23–42% compared to intravenous administration.
The volume of distribution corresponds to the volume of circulating plasma or is 2 times larger than it.
In patients with uremia and healthy people who participated in clinical trials, the half-life of epoetin beta when administered intravenously is 4-12 hours, with subcutaneous administration - 13-28 hours. The pharmacokinetics of the drug in patients with hepatic insufficiency has not been studied.
Indications for use
- Symptomatic anemia: renal genesis in patients not yet receiving dialysis, against the background of chronic kidney disease in dialysis patients, with solid and hematological non-myeloid tumors in adults receiving chemotherapy;
- Anemia in premature infants born before 34 weeks of gestation with a weight of 0.75-1.5 kg (prevention);
- An increase in the volume of donor blood, which is intended for subsequent autotransfusion (taking into account the registered probability of thromboembolic events and only for patients with moderate anemia (with hemoglobin (Hb) 100-130 g / l or 6.21-8.07 mmol / l), without iron deficiency) in cases where it is impossible to obtain a sufficient amount of canned blood, and in the process of a planned major elective surgery, a large volume of blood may be required (≥5 units for men, ≥4 units for women).
Contraindications
Absolute:
- A stroke or myocardial infarction within the previous month;
- Uncontrolled arterial hypertension;
- Increased risk of deep vein thrombosis (in the presence of anamnestic data indicating venous thromboembolism) or unstable angina (in the case of the appointment of Recormon in order to increase the volume of donated blood);
- Age up to 3 years (for the drug in cartridges);
- Hypersensitivity to benzoic acid (when using Recormon solution in cartridges);
- Hypersensitivity to drug components.
Relative (Recormon is prescribed with caution in the presence of the following diseases / conditions):
- Chronic liver failure;
- Refractory anemia in the presence of blast-transformed cells;
- Epilepsy;
- Thrombocytosis;
- Weight up to 50 kg (if prescribed to increase the volume of donated blood);
- The period of pregnancy and lactation (due to insufficient clinical data).
Instructions for the use of Recormon: method and dosage
Anemia associated with chronic kidney disease
Method of administration of Recormon: subcutaneously or intravenously for 2 minutes. For patients on hemodialysis, the solution is injected through an arteriovenous shunt at the end of the dialysis session. Subcutaneous administration of the drug is recommended for patients not receiving hemodialysis (to avoid puncture of peripheral veins).
The goal of therapy is a hemoglobin index in the range from 100 to 120 (maximum) g / l. With an increase in Нb over 4 weeks by more than 20 g / l (1.3 mmol / l), the dose of Recormon is reduced. With arterial hypertension, cardiovascular and cerebrovascular diseases, the weekly increase in hemoglobin and its target indicators are determined individually, based on the clinical picture. Patients need careful monitoring in order to select the lowest dose that will maximize the effect.
The therapy is carried out in 2 stages, including correction and supportive therapy.
Correction (maximum weekly dose - 720 IU / kg per week, regardless of the route of administration):
- Subcutaneous injection: 3 times a week at an initial dose of 20 IU / kg. If the effect is insufficient (less than 2.5 g / l per week), the dose may be increased every 28 days by 20 IU / kg 3 times a week. The total weekly dose of the drug can also be divided into daily administrations;
- Intravenous administration: 3 times a week at an initial dose of 40 IU / kg. If the effect is insufficient, after a month, the dose may be increased to 80 IU / kg 3 times a week. In the future, the dose, if necessary, is increased by 20 IU / kg 3 times a week, with a monthly interval.
Supportive therapy is carried out in order to maintain the target Hb value (100-120 g / l), for this, first, the dose of Recormon must be reduced by 2 times from the previous dose. Further correction is carried out individually, with an interval of 14 or 28 days. The weekly dose for subcutaneous administration can be administered in 1 dose or divided into 3 or 7 administrations per week. After stabilization of the condition, when using the drug once a week, it is possible to switch to the administration of Recormon once every 2 weeks (an increase in the dose may be required).
As a rule, therapy is long-term. If necessary, it can be interrupted at any time.
Symptomatic anemia in solid and hematological nonmyeloid tumors while receiving chemotherapy
Method of administration of Recormon: subcutaneously.
The initial weekly dose is 30,000 IU (450 IU / kg per week). Frequency rate of application - once or 3 or 7 injections per week.
The drug is prescribed for Hb ≤110 g / l (6.83 mmol / l). The maximum Hb index is 130 g / l (8.07 mmol / l).
If Hb increases by 10 g / l (0.62 mmol / l) after 4 weeks, dose adjustment is not performed. At a lower rate of increase, the dose is doubled.
If, after 8 weeks, an increase in hemoglobin of 10 g / l is not achieved, therapy is discontinued, since the further effect of treatment is unlikely.
The therapy is continued for 4 weeks after the end of chemotherapy.
The maximum weekly dose is 60,000 IU.
After reaching the desired hemoglobin value, the dose of Recormon is reduced by 25-50%.
In order to prevent an increase in Hb above 130 g / l, a further dose reduction may be required.
With an increase in hemoglobin more than 20 g / l (1.3 mmol / l) per month, a dose reduction of 25-50% is shown.
Anemia in premature newborns (prevention)
Recormon can only be used in syringe tubes.
The solution is injected subcutaneously 3 times a week at a dose of 250 IU / kg. It is recommended to start therapy as early as possible, preferably from the 3rd day of life. The duration of the course is 6 weeks.
The dose of the drug for children and adolescents is determined by age (the younger the age, the higher doses of the drug are required). Due to the inability to predict the individual response to therapy, it is recommended to start administration with a standard dosage regimen. In case of anemia associated with chronic kidney disease, Recormon should not be prescribed for children under 2 years of age.
Preparation for taking donor blood
Method of administration of the drug: intravenously (within 2 minutes) or subcutaneously.
Frequency rate of application - 2 times a week, course duration - 4 weeks. If the hematocrit (≥ 33%) allows blood sampling, Recormon is recommended to be administered at the end of the procedure.
The hematocrit throughout the entire course of therapy should not exceed 48%.
The dose of Recormon is determined by the transfusion physician and the surgeon individually based on the required blood volume and erythrocyte reserve.
Blood volume is expressed in units (1 unit = 180 ml of erythrocytes) and is determined by the estimated blood loss, available blood conservation techniques and the general condition of the patient; the goal is volume to avoid blood transfusion from another donor.
Donation is determined primarily by the patient's blood volume and baseline hematocrit. These indicators determine the endogenous erythrocyte reserve, which can be calculated using the formula:
Endogenous erythrocyte reserve = blood volume [ml] x (hematocrit - 33): 100
For men: blood volume [ml] = 44 [ml / kg] x weight [kg] + 1600 [ml] (if weight ≥ 45 kg)
For women: blood volume [ml] = 41 [ml / kg] x weight [kg] + 1200 [ml].
Maximum weekly dose:
- Subcutaneous injection: 1200 IU / kg;
- Intravenous administration: 1600 IU / kg.
The syringe tube is ready to use. The solution contained in it does not contain preservatives and is sterile. You can only use a clear, light or slightly opalescent solution that does not contain visible inclusions. If after a single dose a certain amount of solution remains in the syringe tube, its re-introduction is unacceptable.
The cartridge for the syringe pen "Reco-Pen" is two-section, in one section there is a lyophilisate for the preparation of a solution for subcutaneous administration, in the other - a solvent with preservatives. To prepare the solution, the cartridge is inserted into the pen in accordance with the instructions.
Side effects
During treatment with the drug, the following disorders may develop (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rarely):
- Cardiovascular system: often - arterial hypertension (development or strengthening of an existing one), especially in the case of a rapid increase in hematocrit; infrequently - hypertensive crisis with symptoms of encephalopathy (in the form of headaches and confusion, sensory and motor disorders - disturbances in gait, speech, up to tonic-clonic seizures), thromboembolic complications in cancer patients and in patients preparing for autotransfusion (clear cause no investigative link has been established);
- Central nervous system: often - headaches, including sudden onset migraine-like headaches;
- Hematopoietic system: dose-dependent increase in the number of platelets (does not go beyond the normal range, goes away on its own with continued treatment), especially after intravenous administration of the solution; rarely - shunt thrombosis (the risk of development increases with inadequate heparinization), especially if there is a tendency to lower blood pressure or with complications of arteriovenous fistula (including stenosis, aneurysm); very rarely - thrombocytosis;
- Allergic reactions: rarely - itching, skin rash, urticaria; very rarely - anaphylactoid reactions;
- Laboratory indicators: a decrease in the concentration of ferritin in the serum against the background of an increase in Hb, a decrease in serum iron metabolism; in patients with uremia - transient hyperkalemia (a clear causal relationship has not been established), hyperphosphatemia; in premature infants: very often - a decrease in serum ferritin concentration, a slight increase in the number of platelets, up to 12-14 days of life;
- Others: reactions at the injection site, flu-like symptoms (especially at the beginning of treatment; as a rule, they are mild to moderate in nature and go away on their own after a few hours or days), including fever, chills, pain in bones or limbs, headaches, general malaise.
As a result of post-marketing observation, in some cases, the development of partial red cell aplasia (PCAA), associated with the formation of anti-erythropoietin neutralizing antibodies, was recorded.
Overdose
The therapeutic index of Recormon is quite wide, however, the individual reaction of the body at the beginning of therapy should be taken into account. An excessive pharmacodynamic response is likely, i.e., excessive erythropoiesis, accompanied by serious cardiovascular complications and the risk of death.
If the Hb value is high, it is recommended to temporarily interrupt the Recormon treatment. Phlebotomy is prescribed if necessary.
special instructions
With inadequate use of Recormon by healthy people (for example, as doping), the hemoglobin index can sharply increase, which is accompanied by complications from the cardiovascular system that threaten life.
The first dose of the drug should be administered under the supervision of a physician, since in some cases the development of anaphylactoid reactions was noted.
During treatment, it is necessary to regularly monitor the indicators of platelets, hematocrit and Hb.
Before the appointment of Recormon, it is necessary to exclude the lack of folic acid and vitamin B12, as this can affect the therapy, reducing its effectiveness.
It is necessary to exclude iron deficiency before prescribing the drug, and also to monitor throughout the entire use of Recormon. If necessary, additional therapy with iron preparations can be prescribed.
In severe forms of phenylketonuria, it is necessary to take into account the presence of phenylalanine as an additional component: in each cartridge - up to 0.5 mg, in each syringe-tube - up to 0.3 or 0.6 mg (in dosages of 1000/2000 ME or 10,000/20 000/30 000 ME).
In most cases, an incomplete clinical response is observed with iron deficiency and inflammation (as a result of progressive metastatic cancer or uremia). A decrease in the effectiveness of therapy occurs against the background of the following diseases / conditions: bone marrow fibrosis, hemolysis, chronic blood loss, a sharp increase in aluminum concentration due to hemodialysis, folic acid or vitamin B12 deficiency. If all of the above conditions are excluded, with a sudden decrease in Hb content, reticulocytopenia and the detection of antibodies to erythropoietin, a bone marrow examination should be performed to exclude PCA. With the development of PACA, Recormon is canceled and the patient is transferred to therapy with other stimulants of erythropoiesis.
If antibodies neutralizing erythropoietin are present (confirmed or suspected), Recormon should not be used.
Consideration should be given to the likelihood that drugs stimulating erythropoiesis can stimulate the growth of any type of malignancy.
In chronic kidney disease or malignant tumors while receiving chemotherapy, episodes of increased blood pressure and worsening of the course of existing arterial hypertension may develop, especially with a sharp increase in Hb content. If you cannot lower blood pressure with medication, you should temporarily cancel Recormon. Blood pressure should be monitored regularly (especially at the beginning of the drug use), incl. between dialysis sessions in patients with renal anemia. In some cases, even with normal or low blood pressure, with chronic kidney disease, a hypertensive crisis with symptoms of encephalopathy may develop (immediate consultation with a therapist is required, especially when sudden migraine-like acute headaches appear).
During the period of therapy, periodic monitoring of serum potassium levels is recommended (with the development of hyperkalemia, Recormon is temporarily canceled).
In chronic kidney disease during hemodialysis sessions, an increase in the dose of heparin is required (due to an increase in the hemoglobin content). With inadequate heparinization, an occlusion of the dialysis system can develop. It is recommended to carry out early revision of the shunt and timely prevention of thrombosis (for example, taking acetylsalicylic acid).
During the period of therapy, there may be a moderate dose-dependent increase in the number of platelets within the normal range (returns to normal values on its own).
Recormon is indicated only for those patients for whom it is most important to avoid homologous blood transfusion, given the balance of benefits and risks with homologous transfusion.
The use of the drug in premature infants (for the prevention of anemia) may lead to a slight increase in the number of platelets (their regular monitoring is recommended).
In nephrosclerosis, the question of prescribing Recormon should be decided individually, since the likelihood of a more rapid deterioration in renal function cannot be ruled out.
In most cases, an increase in hemoglobin is accompanied by a decrease in serum ferritin concentration. With anemia of renal origin and with a serum ferritin concentration of less than 100 μg / l or transferrin saturation less than 20%, oral administration of iron preparations (Fe 2+) in a daily dose of 200-300 mg is recommended.
Therapy with iron preparations for patients with oncological and hematological diseases should be carried out according to the same principles, while in case of multiple myeloma, non-Hodgkin's lymphomas or chronic lymphocytic leukemia with transferrin saturation less than 25%, intravenous administration of Fe 3+ at a dose of 100 mg per week is possible. Oral therapy with iron preparations for premature infants (at a dose of 2 mg Fe 2+ per day) should be prescribed as early as possible (the latest is the fourteenth day of life). The iron dose is determined by the serum ferritin level. If it persists at a level of up to 100 μg / ml, or in the presence of other signs of iron deficiency, the daily dose of iron preparations is increased to 5-10 mg (therapy is continued until the signs of iron deficiency have subsided).
In case of moderate anemia, Recormon is prescribed prior to planned major surgical interventions taking into account the advantages of using epoetin beta and an increased risk of thromboembolic complications.
It should be borne in mind that the cartridge with the Recormon solution contains benzyl alcohol as a preservative, which in newborns can cause neurological and other complications (sometimes fatal).
Application during pregnancy and lactation
According to the instructions, Recormon is prescribed with caution during pregnancy or during childbirth, since there is no sufficient clinical experience with its use during this period.
Endogenous erythropoietin passes into breast milk and is completely absorbed in the gastrointestinal tract of the newborn. The question of the advisability of continuing lactation or undergoing treatment with Recormon is decided by correlating the potential effectiveness of therapy for the mother and the benefits of breastfeeding for the child.
Experimental studies on animals have shown that epoetin beta is uncharacteristically teratogenic.
With impaired renal function
A sharp increase in the concentration of aluminum during the treatment of renal failure can reduce the effectiveness of Recormon.
The decision to prescribe the drug to patients with nephrosclerosis not undergoing dialysis should be made on an individual basis, since the risk of a more rapid deterioration of renal function cannot be completely ruled out.
Use in the elderly
Clinical studies confirm that elderly patients do not need dose adjustment.
Drug interactions
Any interaction of Recormon with other drugs / substances has not yet been identified.
To avoid incompatibility or decrease in the activity of epoetin beta, it must not be mixed with other drugs / injection solutions or use a different solvent.
Analogs
Rekormon's analogs are: Vero-Epoetin, Erythrostim, Epostim, Epoetin, Erythropoietin, Epoetin Beta.
Terms and conditions of storage
Store in a dark place, out of reach of children, at a temperature of 2-8 ° C, the drug should not be frozen.
Shelf life is 2 years.
The syringe pen "Reco-Pen" with an inserted cartridge can be stored for 1 month at a temperature of 2-8 ° C. Remove the drug from the refrigerator only for injection.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Recormon
Judging by the reviews, Recormon is most often used for anemias caused by chronic renal failure, malignant oncological diseases and bone marrow damage. The effect of prescribing the drug becomes noticeable after 1–2 weeks after the start of treatment, and after 2–3 months hematopoiesis is completely normalized.
Recormon is also used in cases where the development of anemia is associated with the presence of a chronic disease (for example, chronic heart failure, coronary heart disease, rheumatoid arthritis).
The drug is prescribed for more than 20 weeks of gestation with a reduced production of erythropoietin and iron deficiency anemia. Its use in this case is quite justified, since the drug ensures the delivery of iron taken by a pregnant woman to the bone marrow, which contributes to the intensification of erythropoiesis.
Patients note the good tolerance of the drug, however, with the introduction of high doses, side effects are observed: headache, dizziness, increased blood pressure, pain in the chest, sometimes thrombosis and convulsions. Also, some patients complain about the high cost of Recormon.
Price for Recormon in pharmacies
The price of Rekormon for a 2000 IU syringe tube averages 1,000–1200 rubles per unit. The drug is in the same dosage in the amount of 6 pcs. costs approximately 5600–6300 rubles. The price for Rekormon 10,000 IU is approximately 5,500–6,000 rubles for 1 syringe tube and 29,600–31,000 rubles for 6 syringe tubes. The drug in a dosage of 30,000 IU will cost about 8,400–9600 rubles for 1 syringe tube and 13,400–13,700 rubles for 6 syringe tubes.
Rekormon: prices in online pharmacies
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Drug name Price Pharmacy |
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Recormon 2000 IU solution for intravenous and subcutaneous administration 0.3 ml 6 pcs. 5590 RUB Buy |
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Recormon 10000 IU solution for intravenous and subcutaneous administration 0.6 ml 6 pcs. RUB 30,300 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
