6 injectors 2000M
Recormon (Epoetin) is used to treat severe anemia.
Release form, composition and packing:
Colorless, transparent liquid; prepared solution - a colorless, transparent or slightly opalescent liquid.
Other ingredients: urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-Leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine.
Benzyl alcohol, benzalkonium chloride, water, d / and (1 ml).
Stimulant of hematopoiesis. Epoetin beta - glycoprotein consisting of 165 amino acids, which, as a mitogenic factor and differentiation hormone, promotes the formation of red blood cells from a partially deterministic progenitor cells of erythropoiesis.
Recombinant epoetin beta produced by genetic engineering, in its amino acid and carbohydrate composition is identical to the human erythropoietin.
Epoetin beta after iv and sc administration increases the number of red blood cells, reticulocytes and hemoglobin levels, as well as the rate of incorporation of iron (59Fe) in cells which specifically stimulates erythropoiesis, without affecting the leykopoez. Cytotoxic effect of epoetin beta on bone marrow cells or human skin were found.
Bioavailability of epoetin beta at s / c infusion 23-42%. When s / c infusion of the drug in patients with uraemia prolonged absorption provides a plateau drug concentration in serum. Tmax - 12-28 hours
Patients with uremia and in healthy volunteers, T1 / 2 at / in the introduction of 12.4 hours T1 / 2 terminal phase in the s / c infusion than after iv injection, averaging 13-28 hours
Pharmacokinetics in special clinical situations
Pharmacokinetics of epoetin beta in patients with liver failure has not been studied.
symptomatic anemia in chronic kidney disease patients on dialysis;
symptomatic anemia of renal origin in patients not yet on dialysis;
treatment of symptomatic anemia in adults with solid tumors and hematological nemieloidnymi receiving chemotherapy;
to increase the volume of donor blood, intended for subsequent autotransfusion (c registered account the risk of thromboembolic events and only for patients with moderate anemia (Hb 100-130 g / L or 6.21-8.07 mmol / l), no iron deficiency), if a a sufficient number of preserved blood is not possible, and planned major elective surgery may require a large volume of blood (> 4 units for women or> 5 units for males);
prevention of anemia in premature newborns weighing 750-1500 g and 34 weeks of gestation.
Treatment of anemia in patients with chronic kidney disease
Injected sc or iv within 2 min. Patients on hemodialysis - through arteriovenous shunt at the end of dialysis. Patients not receiving dialysis, the drug is preferably administered sc, to avoid puncture of peripheral veins.
The goal of treatment - an indicator of hemoglobin (Hb) of 100-120 g / liter. Hb should not exceed 120 grams per liter. An increase in Hb by more than 20 g / L (1.3 mmol / L) for 4 weeks dose should be reduced. In patients with hypertension, cardiovascular and cerebrovascular diseases weekly increase in hemoglobin and its targets should be determined individually, depending on the clinical picture. Should conduct a careful observation of the patient in order to select the minimum dose sufficient to provide the maximum effect of the drug. Treatment Recormon carried out in 2 stages.
Stage of correction. N / a, the initial dose - 20 IU / kg 3 times a week. With insufficient increase in Hb (less than 2.5 g / week) dose may be increased every 4 weeks to 20 IU / kg 3 times a week. The total weekly dose of the drug can also be divided by daily injection. In / in, the initial dose - 40 IU / kg 3 times a week. With insufficient increase of Hb in a month dose may be increased to 80 IU / kg 3 times a week. If necessary, further doses should be increased to 20 IU / kg 3 times a week, at monthly intervals.
Regardless of the mode of administration, the maximum dose should not exceed 720 IU / kg per week.
Supportive therapy. To maintain the target Hb (100-120 g / L) dose should first be reduced by a factor of 2 from the previous dose. Subsequently, the maintenance dose is selected individually, with an interval of 2 or 4 weeks. When s / c infusion weekly dose may be administered for 1 admission or divide by 3 or 7 injections per week. When stabilization against the introduction of 1 time per week you can go to the introduction of 1 every 2 weeks, in this case may need to increase the dose.
Treatment Recormon usually done for a long time. If necessary, it can be interrupted at any time.
Treatment of symptomatic anemia in patients with solid tumors and hematological nemieloidnymi receiving chemotherapy:
The drug is administered sc, at an initial dose of 30,000 IU per week (450 ME / kg per week), single or separated by a weekly dose for 3 or 7 injections.
Recormon therapy is indicated for Hb ≤ 110 g / L (6.83 mg / dL). The index of Hb should not exceed 130 g / L (8.7 mmol / l).
An increase in Hb of 10 g / L (0.62 mg / dL) after 4 weeks - therapy should continue at the same dose.
An increase in Hb of less than 10 g / L (0.62 mg / dL) after 4 weeks - the dose should be doubled.
In the absence of increase of Hb of 10 g / L (0.62 mg / dL) after 8 weeks - treatment should be discontinued because response to therapy Recormon unlikely.
Treatment should continue for 4 weeks after chemotherapy.
The maximum dose should not exceed 60 000 ME per week.
Upon reaching the target Hb for the individual patient dose should be reduced by 25-50%.
To prevent the increase of Hb of more than 130 g / L may require further dose reduction.
With an increase in Hb by more than 20 g / L (1.3 mmol / l) per month, should reduce the dose Recormon by 25-50%.
Preparing patients for taking blood for subsequent autotransfusion:
V / a (within 2 min) or n / a, 2 times per week for 4 weeks. In cases where the hematocrit in a patient (≥ 33%) allows for blood sampling, Recormon should enter at the end of the procedure.
Throughout the course of treatment hematocrit should not exceed 48%.
Dose is determined by the physician and surgeon-transfusion individually, depending on how much blood is taken from the patient and his erythrocyte reserve:
1. Blood volume, which will be taken from the patient, depending on the expected blood loss of available blood conservation techniques and general condition of the patient, it should be sufficient to avoid transfusion of blood from another donor.
2. Blood volume, which will be taken from the patient, expressed in units (1 unit is equivalent to 180 ml of red blood cells).
3. The possibility of donation depends mainly on the volume of blood in this patient and the initial hematocrit. Both measures determine the endogenous erythrocyte reserve, which is calculated as follows:
Endogenous erythrocyte reserve = blood volume [ml] x (hematocrit - 33): 100
Women: blood volume [ml] = 41 [ml / kg] x body weight [kg] + 1200 [ml]
Men: blood volume [ml] = 44 [ml / kg] x body weight [kg] + 1600 [ml] (with a body weight> 45 kg).
Indications Recormon and its single dose determined by the nomograms, based on the required volume of donor blood and erythrocytic endogenous reserves. The maximum dose should not exceed 1,600 IU / kg / week for iv administration and 1200 IU / kg per week for subcutaneous administration.
Prevention of anemia in preterm infants:
The drug used only in the syringe tubes. Injected sc at a dose of 250 IU / kg 3 times a week, as soon as possible, preferably with 3 days of life, within 6 weeks.
In children and adolescents dose depends on age: as a rule, the younger, the higher dose Recormon required. But since the individual response to the drug can be predicted, it is advisable to start with the standard dosing regimen. In the treatment of anemia associated with chronic kidney disease, Recormon should not be given to children under 2 years.
In clinical studies, elderly patients need to change the dose to be determined.
Syrette with drug Recormon ready for use. Is contained in the solution is sterile and contains no preservatives. Should apply only a light transparent or slightly opalescent solution containing no visible impurities. If, after injection into the syringe tube remains a certain amount of drug re-introduction of its unacceptable.
Instructions for use:
Before injecting, wash hands.
1. Take out a syringe-tube from the package and make sure that the solution is transparent, colorless and contains no visible impurities. Remove the cap from the syringe.
2. Remove from the packaging one needle, put it on the syringe and remove the needle cap.
3. Remove air from the syringe and needle, holding the syringe vertically and gently pushing the plunger up. Push the plunger up until the syringe will remain a necessary dose Recormon.
4. Wipe the skin at the injection site with an alcohol cotton. Thumb and index finger to take the skin in the crease. Holding the syringe body closest to the needle to enter the needle under the skin. Enter solution Recormon. Quickly remove the needle and press the spot with a dry sterile cotton wool.
Cartridge Recormon for syringe handles Reco-Pen is a two-piece cartridge containing lyophilized for solution for subcutaneous injection and solvent preservatives. The finished solution is obtained by introducing the cartridge into the syringe handle Reco-Pen, in accordance with the instruction.
Cartridges Recormon should only be used in the syringe handle Reco-Pen. It is recommended to use needles for injection pens Reco-Pen (such as needles, "Penfayn). The mixed solution in the cartridge is stored for 1 month at 2 ° to 8 ° C. After installing the cartridge, syringe-pen Reco-Pen is removed from the refrigerator only at the time of injection.
With the cardiovascular system: often - the emergence or strengthening of existing arterial hypertension (> 1%, <10%), especially in the case of rapid rise in hematocrit, hypertensive crisis with signs of encephalopathy (headache, confusion, sensory and motor disturbances - speech impairment, gait, up to the tonic-clonic seizures), thromboembolic complications in cancer patients (> 0.1% <1%) and in patients being prepared for autotransfusion (a clear causal relationship with the drug not established).
CNS:> 1%, <10% - headaches, including suddenly occurring migraine headaches.
From the hemopoietic system: a dose-dependent increase in the number of platelets (not beyond the normal limits and disappearing with continued therapy), especially after iv administration of the drug, 0.01% - thrombocytosis,> 0.01%, 0.1% - shunt thrombosis (possibly inadequate heparinization), especially in patients with a tendency to lower blood pressure, or with complications of arteriovenous fistula (including stenosis, aneurysm).
Allergic reactions: rarely (by ≥ 1 / 10 000 to ≤ 1 / 1000) - skin rash, itching, hives, very rare (≤ 1 / 10 000) - anaphylactoid reaction.
From the laboratory parameters: reduction of serum ferritin in the serum while increasing Hb, decrease in serum iron metabolism, in patients with uremia - transient hyperkalemia (a clear causal relation with drug intake is not installed), hyperphosphatemia. Premature infants - reducing the concentration of serum ferritin (> 10%), a slight increase in the number of platelets, particularly from 12 to 14-day life.
Other: injection site reactions, flu-like symptoms (especially early in therapy usually are mild or moderate and disappear after a few hours or days), including fever, chills, headaches, pains in the limbs or bones, general malaise.
Post-marketing surveillance: the therapy Recormon reported sporadic cases (0.107 cases per 10 000 patient-years in the application Recormon for treatment of anemia of renal origin in the iv and sc, and 0.158 cases per 10 000 patient-years in the s / c infusion Recormon for treatment of anemia of renal origin) partial red cell aplasia caused by the formation of neutralizing anti-erythropoietin antibodies.
Be wary of refractory anemia with the presence of blasttransformirovannyh cells, thrombocytosis, epilepsy and chronic liver failure, birth weight less than 50 kg to increase the amount of donated blood for subsequent autotransfusion.
Pregnancy and lactation:
Safety Information Recormon during pregnancy, during childbirth and lactation (breastfeeding) was obtained at post-registration application.