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Instruction for use: Recormon

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Dosage form: Lyophilizate for the preparation of a solution for intravenous and subcutaneous administration; Solution for intravenous and subcutaneous administration

Active substance: Epoetinum beta

ATX

B03XA01 Erythropoietin

Pharmacological group:

Stimulators of hemopoiesis

The nosological classification (ICD-10)

D63.0 Anemia in neoplasm: Anemia in chronic diseases; Anemia due to radiation damage; Radiation anemia; Anemia in patients with solid tumors; Pernicious anemia

D63.8 Anemia in other chronic diseases classified elsewhere: Anemia in chronic diseases; Anemia in immunological disorders; Anemia in peptic ulcer; Anemia in kidney diseases; Anemia with HIV treatment; Anemia in the background of chronic renal failure; Anemia in patients with myeloma; Symptomatic anemia; Symptomatic anemia of renal genesis; Anemia in HIV-infected patients; Renal anemia

N18.9 Chronic renal failure, unspecified: Edema of renal genesis

P61.2 Anemia of prematurity: Anemia in preterm infants; Anemia of physiological preterm infants

Composition and release form

A solution for intravenous and intravenous administration of 1 bar-tube.

Epoetin beta 1000 ME; 2000 ME

Auxiliary substances: 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; water for injections

In syringes-tubes of 0.3 ml (complete with needles for injections); In the packaging of the contour mesh 3 sets; In a pack of cardboard 2 packs.

A solution for intravenous and intravenous administration of 1 bar-tube.

Epoetin beta 10,000 IU; 20000 IU; 30000 IU

Auxiliary substances: 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; water for injections

In syringes-tubes of 0.6 ml (complete with needles for injections); In the packaging of the contour mesh 3 sets; In a pack of cardboard 2 packs (10,000 and 20,000 IU each); 1 or 4 packs (30,000 IU each).

Liofilizate for the preparation of a solution for SC injection 1 cartridge

The first section

Epoetin beta 10,000 IU; 20000 IU

Auxiliary substances: 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

Second Section

Solvent: benzyl alcohol; Benzalkonium chloride; water for injections

In a pack of cardboard 1 two-section cartridge (for the syringe-handle "Reko-Pen")

Description of dosage form

Solution for intravenous and subcutaneous administration - colorless, transparent or slightly opalescent liquid.

The lyophilizate is a homogeneous powder or a porous mass of white or almost white color.

Solvent is a colorless, clear liquid.

The reconstituted solution is a colorless, clear or slightly opalescent liquid.

Pharmachologic effect

Mode of action - Hematopoietic.

Pharmacodynamics

Epoetin beta is a glycoprotein consisting of 165 amino acids, which, being a mitogenic factor and a differentiation hormone, promotes the formation of erythrocytes from partially determined progenitor cells of erythropoiesis. Recombinant epoetin beta, obtained by genetic engineering, is identical in its amino acid and carbohydrate composition to human erythropoietin.

Epoetin beta after intravenous and subcutaneous administration increases the number of erythrocytes, reticulocytes and hemoglobin level, as well as the rate of iron incorporation (59Fe) into cells, specifically stimulates erythropoiesis without affecting leukopoiesis. The cytotoxic effect of epoetin beta on the bone marrow or on human skin cells has not been revealed.

Pharmacokinetics

Suction. With SC administration of the drug to patients with uremia, long-term absorption provides a plateau of drug concentration in the serum, the time to reach Cmax is 12-28 h.

Bioavailability of epoetin beta with SC introduction - 23-42% compared with the intravenous administration.

Distribution. The volume of the distribution is equal to the volume of the circulating plasma, or 2 times its volume.

Excretion. In patients with uremia and in healthy volunteers, T1 / 2 with intravenous administration is 4-12 hours T1 / 2 terminal phase with a sc administration greater than after iv injection, and is on average 13-28 hours.

Pharmacokinetics in special groups of patients. The pharmacokinetics of epoetin beta in patients with hepatic insufficiency has not been studied.

Indication of the drug Recormon

Symptomatic anemia in chronic kidney disease in patients on dialysis;

Symptomatic anemia of renal genesis in patients not yet receiving dialysis;

Treatment of symptomatic anemia in adult patients with solid and hematological non-myeloid tumors receiving chemotherapy;

An increase in the volume of donor blood intended for subsequent autotransfusion. The registered risk of thromboembolic events should be taken into account. The use of this indication is possible only in patients with moderate anemia (hemoglobin level - 100-130 g / l (6.21-8.07 mmol / l), without iron deficiency) if it is impossible to obtain sufficient amount of canned blood, and planned large Elective surgery may require a large volume of blood (≥4 units - for women or ≥5 units - for men);

Prevention of anemia in premature newborns born with a body weight of 750-1500 g to 34 th week of pregnancy.

Contraindications

Hypersensitivity to epoetin beta or any of the components of the drug (with the use of Recormon® for the Reko-Pen syringe pen - also an increased sensitivity to benzoic acid - a metabolite of benzyl alcohol);

Uncontrolled arterial hypertension;

Myocardial infarction or stroke during the previous month, unstable angina or increased risk of deep vein thrombosis (with venous thromboembolism in the anamnesis) - with an appointment to increase the volume of donor blood for autohemotransfusion;

Age up to 3 years - for cartridges with lyophilizate for the preparation of solution for p / c injection.

Carefully:

Refractory anemia in the presence of blast-transformed cells, thrombocytosis, epilepsy and chronic hepatic insufficiency;

Body weight <50 kg to increase the volume of donor blood for subsequent autotransfusion.

Application in pregnancy and breastfeeding

Epoetin beta does not have teratogenic effects on animals. Information on the safety of the use of Recormon® during pregnancy, during labor and during breastfeeding was obtained by the post-marketing use of the drug. In pregnancy or during childbirth, Recormon® should be administered with caution, since there is not sufficient experience in pregnancy and during childbirth. Endogenous erythropoietin is secreted into breast milk and completely absorbed into the digestive tract of the newborn. The choice between continuing breastfeeding or continuing with Rekormon® therapy is done taking into account the benefits of therapy for the mother and the benefits of breastfeeding for the baby.

Side effects

Cardiovascular system: often - occurrence or strengthening of an already existing arterial hypertension (> 1, <10%), especially in case of rapid hematocrit increase; Hypertensive crisis with the phenomena of encephalopathy (headaches and confusion, sensory and motor disorders - speech disorders, gait, up to tonic-clonic seizures), thromboembolic complications in cancer patients (> 0.1, <1%) and in patients preparing To autotransfusion (there is no clear causal relationship with the drug).

Nervous system: headaches (> 1, but <10%), incl. Sudden migraine-like headaches.

The system of hematopoiesis: a dose-dependent increase in the number of platelets (not exceeding the norm and disappearing with the continuation of therapy), especially after intravenous administration of the drug. Rarely, thrombocytosis (<0.01%). Shunt thrombosis (> 0.01%, <0.1%) (possibly with inadequate heparinization), especially in patients with a tendency to decrease blood pressure or with complications of arteriovenous fistula (eg stenosis, aneurysm, etc.).

Laboratory indicators: a decrease in serum ferritin concentration simultaneously with an increase in hemoglobin, a decrease in serum iron metabolism. In patients with uremia - transient hyperkalemia (a clear causal relationship with the drug is not established), hyperphosphatemia.

In premature newborns: a decrease in serum ferritin (> 10%), a slight increase in the number of platelets, especially up to the 12-14th day of life.

Other: rarely (from ≥1 / 10000 to ≤1 / 1000) - skin allergic reactions: rash, itching, urticaria; Reactions at the injection site. Very rarely (≤1 / 10000) - anaphylactoid reactions; Influenza-like symptoms (especially at the beginning of therapy) are usually mild or moderate and disappear after a few hours or several days: fever, chills, headaches, pains in the extremities or bones, malaise.

Post-marketing surveillance: Recombinant® has been reported to have isolated cases (0.107 cases per 10,000 patient years with the use of Recormon® for the treatment of anemia of renal genesis IV and S / I and 0.158 cases per 10,000 patient years with the introduction of Recormon® For the treatment of anemia of renal genesis) of partial red cell aplasia caused by the formation of neutralizing antierythropoietin antibodies (see "Special instructions").

Interaction

he data obtained so far have not revealed any interactions of Recormon® with other drugs. To avoid incompatibility or decrease in drug activity, another solvent should not be used and the drug should be mixed with other drugs or injectable solutions.

Dosing and Administration

Treatment of anemia in patients with chronic kidney disease

SC or IV, for 2 minutes. Patients on hemodialysis - through the arteriovenous shunt at the end of the dialysis session. Patients who do not receive hemodialysis, preferably enter the drug sc, to avoid puncture of peripheral veins. The goal of the treatment is the hemoglobin (Hb) value of 100-120 g / l. Hemoglobin should not exceed 120 g / l. With an increase in Hb by more than 20 g / l (1.3 mmol / L) for 4 weeks, the dose of the drug should be reduced. In patients with hypertension, cardiovascular and cerebrovascular diseases, weekly increase in Hb and its targets should be determined individually, depending on the clinical picture. Careful observation of the patient should be carried out in order to select the minimum dose sufficient to ensure the maximum effect of the drug. Treatment Rekormon ® is carried out in 2 stages.

Correction stage

SC, the initial dose is 20 IU / kg 3 times a week. With an insufficient increase in Hb (less than 2.5 g / L per week), the dose can be increased every 4 weeks by 20 IU / kg 3 times a week. The total weekly dose of the drug can also be divided into daily injections.

IV, the initial dose is 40 IU / kg 3 times a week. If the Hb is not increased enough, the dose can be increased to 80 IU / kg 3 times a week in a month. If necessary, in the future, the dose should be increased by 20 IU / kg 3 times a week, with a monthly interval.

Regardless of the route of administration, the maximum dose should not exceed 720 IU / kg per week.

Supportive therapy

To maintain the target Hb (100-120 g / l), the 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. With n / to the introduction of a weekly dose can be administered for 1 reception or divide by 3 or 7 administrations per week. When the state stabilizes against a background of a single injection per week, you can switch to a single injection at a two-week interval, in which case an increase in dose may be required.

Treatment of Recormon®, as a rule, is carried out for a long time. If necessary, it can be interrupted at any time.

Treatment of symptomatic anemia in patients with solid and hematological non-myeloid tumors receiving chemotherapy

The drug is given SC, at an initial dose of 30,000 IU per week (450 IU / kg per week), a single or weekly dose can be divided into 3 or 7 injections.

Therapy Recormon® is shown Hb ≤110 g / l (6.83 mmol / l). The indicator of Hb should not exceed 130 g / l (8.07 mmol / l).

If Hb is increased by 10 g / L (0.62 mmol / L) after 4 weeks, the therapy should continue at the same dose.

With an increase in Hb of less than 10 g / l (0.62 mmol / l) after 4 weeks, the dose should be doubled.

In the absence of an increase in Hb by 10 g / l (0.62 mmol / l) after 8 weeks of treatment should be interrupted, t. Response to Rekormon® therapy is unlikely.

Treatment should continue for 4 weeks after the end of chemotherapy.

The maximum dose should not exceed 60,000 IU per week.

When the Hb target is reached for a particular patient, the dose of the drug should be reduced by 25-50%.

To prevent an increase in Hb of more than 130 g / l, further dose reduction may be required.

If Hb increases by more than 20 g / L (1.3 mmol / L) per month, the dose of Recormon® should be reduced by 25-50%.

Preparation of patients for the collection of donor blood for subsequent autohemotransfusion

IV (for 2 min) or sc, twice a week for 4 weeks. In those cases where the hematocrit in the patient (≥33%) allows for blood sampling, Recormon® should be inserted at the end of the procedure.

Throughout the course of treatment, the hematocrit should not exceed 48%

The dose of the drug is determined by the transfusiologist and the surgeon individually, depending on how much blood is taken from the patient and from his erythrocyte reserve:

1. The amount of blood that will be taken from the patient depends on the estimated blood loss, available methods of blood preservation and the general condition of the patient; It should be sufficient to avoid transfusion of blood from another donor.

2. The volume of blood that will be taken from the patient is expressed in units (one unit is equivalent to 180 ml of red blood cells).

3. The possibility of donation depends mainly on the blood volume of the patient and the initial hematocrit. Both indices determine the endogenous red blood cell, which is calculated by the following formula:

Endogenous erythrocyte reserve = volume of blood (ml) × (hematocrit-33): 100

Women: blood volume (ml) = 41 (ml / kg) × body weight (kg) + 1200 (ml)

Men: blood volume (ml) = 44 (ml / kg) × body weight (kg) + 1600 (ml) (with body weight ≥45 kg).

Indication for the use of Recormon® and its single dose are determined from nomograms, based on the required volume of donor blood and the endogenous red blood cell. The maximum dose should not exceed 1600 IU / kg per week - with IV injection and 1200 IU / kg per week - with SC introduction.

Prevention of anemia in premature infants (only syringes-tubes with the drug Recormon®)

SC, 250 IU / kg 3 times a week, as early as possible, preferably from the 3rd day of life, for 6 weeks.

Dosing in special patient groups

Children and teenagers. In children and adolescents, the dose of the drug depends on age: as a rule, the smaller the age, the higher the dose of Recormon® is required. But since an individual response to a drug cannot be predicted, it is advisable to start with a standard dosage regimen (see "Treatment of anemia in patients with chronic kidney disease" and "Prevention of anemia in premature newborns").

In the treatment of anemia associated with chronic kidney disease, Recormon® should not be administered to children under 2 years of age.

Elderly age. In clinical studies, the need for dose changes is not defined.

Mode of application

A syringe with a Recormon® preparation is ready for use. The solution contained in it is sterile and does not contain preservatives. Apply only light clear or slightly opalescent solution that does not contain visible inclusions. If after the injection in the syringe tube a certain amount of the drug remains, the repeated administration of it is unacceptable.

Instructions for the use of a syringe tube

Before injection, wash hands

1. Remove one syringe from the package and make sure that the solution is clear, colorless and does not contain visible inclusions. Remove the cap from the syringe.

2. Remove one needle from the package, put it on the syringe and remove the protective cap from the needle.

3. Remove air from the syringe and needle, holding the syringe upright, gently pushing the piston upward. Push the plunger until the required dose of Recormon® is left in the syringe.

4. Wipe the skin at the injection site with alcohol moistened with cotton wool. A thumb and forefinger to take the skin into a crease. Holding the syringe body closer to the needle, insert the needle under the skin. Enter the solution of Recormon®. Quickly remove the needle and squeeze the injection site with a sterile dry cotton wool.

Cartridge with Recormon® for the pen-handle "Reco-Pen" is a two-section cartridge containing lyophilizate for the preparation of a solution for p / c injection and a solvent with preservatives. The finished solution is obtained by inserting the cartridge into the syringe-pen "Reco-Pen" in accordance with the instructions for "Reco-Pen". Cartridges with Recormon® should be used only in the syringe pen "Reco-Pen". It is recommended to use needles for the "Reko-Pen" syringe pen (for example, "Penfine" needles). The solution prepared in the cartridge is stored for 1 month at a temperature of 2-8 ° C. After installing the cartridge, the "Reco-Pen" syringe pen is removed from the refrigerator only at the time of the injection.

Overdose

Therapeutic index of Recormon® is very wide, however, individual response to therapy at the beginning of treatment should be taken into account.

Symptoms: an excessive pharmacodynamic response is possible; Excessive erythropoiesis with life-threatening cardiovascular complications.

Treatment: at a high Hb it is necessary to temporarily interrupt the treatment with Rekormon® (see "Method of administration and dose"). If necessary, phlebotomy can be performed.

Special instructions

Inadequate use of the drug by healthy people (for example, as a dope) can cause a sharp increase in Hb, accompanied by life-threatening complications from the cardiovascular system.

Since in some cases anaphylactoid reactions were noted, the first dose of the drug should be administered under the supervision of a doctor.

Platelet, hematocrit and Hb values should be monitored regularly against the background of Recormon® therapy.

Caution should be applied to Recormon® for refractory anemia in the presence of blast-transformed cells, epilepsy, thrombocytosis, and chronic liver failure. Prior to the initiation of Recormon® treatment, vitamin B12 and folic acid deficiency should be eliminated, since they reduce the effectiveness of therapy.

It is necessary to exclude iron deficiency before the beginning of treatment with Recormon®, and also during the whole period of therapy. If necessary, additional iron therapy may be prescribed in accordance with clinical guidelines.

In the treatment of patients with severe forms of phenylketonuria, the presence of phenylalanine as an auxiliary substance should be taken into account: in each syringe tube, up to 0.3 mg (in dosages of 1000 and 2000 ME) or up to 0.6 mg (in dosages of 10,000, 20,000, 30000 ME), in each cartridge - up to 0.5 mg.

Absence of effect: the most frequent reasons for the incomplete response to treatment with agents that stimulate erythropoiesis are iron deficiency and inflammation (as a result of uremia or progressive metastatic cancer). The following conditions reduce the effectiveness of treatment with agents that stimulate erythropoiesis: chronic blood loss, bone marrow fibrosis, a sharp increase in the concentration of aluminum due to hemodialysis, deficiency of folic acid or vitamin B12, hemolysis. If all listed conditions are excluded and the patient has a sudden decrease in Hb, reticulocytopenia and antibodies to erythropoietin are detected, a bone marrow examination to exclude partial red cell aplasia (PKA) should be performed. With the development of PKAA therapy, Recormon® should be discontinued and patients should not be transferred to therapy with other stimulants of erythropoiesis. PKAA, caused by neutralizing anti-erythropoietin antibodies, can be associated with therapy with erythropoiesis stimulants, incl. And with Rekormon® therapy (0.107 cases per 10,000 patient-years - with the use of Recormon® for the treatment of anemia of renal genesis IV and S, 0.158 cases per 10,000 patient-years, with the introduction of Rekormon® for the treatment of anemia of the kidney Genesis). It is not recommended to transfer patients to Rekormon® therapy if there is a suspicion of the presence or with confirmed presence of antibodies neutralizing erythropoietin.

Effect on tumor growth: epoetins are growth factors that mainly stimulate the formation of erythrocytes, Erythropoietin receptors can be present on the surface of various tumor cells. It cannot be ruled out that drugs that stimulate erythropoiesis can stimulate the growth of any type of malignant formation.

In clinical studies in the treatment of anemia in cancer patients epoetin beta, there was no statistically significant deterioration in survival and tumor progression.

In patients with chronic kidney disease or with malignant tumors receiving chemotherapy, there may be episodes of increased blood pressure and worsening of the current arterial hypertension, especially with a sharp increase in Hb. Increased blood pressure can be eliminated medically, in the absence of effect, a temporary break in the treatment of Recormon® is necessary. It is recommended to regularly monitor blood pressure (especially at the beginning of therapy), incl. Between dialysis sessions in patients with anemia of renal genesis. Individual patients with chronic kidney disease may experience a hypertensive crisis with encephalopathy, even with normal or low blood pressure. Immediate consultation of the therapist is necessary and especially when sudden sudden migraine headaches occur.

During treatment with Recormon®, it is recommended that the serum levels of potassium be monitored periodically. If hyperkalaemia occurs, you should temporarily discontinue Recormon® before normalizing the potassium concentration.

Patients with chronic kidney disease require an increase in the dose of heparin during the hemodialysis session due to an increase in Hb. Occlusion of the dialysis system is possible with inadequate heparinization. Early shunt revision and timely prevention of thrombosis (eg, acetylsalicylic acid) is recommended.

A moderate dose-dependent increase in the number of platelets within normal limits is possible, especially after the administration of Recormon®, with subsequent independent return to normal values while continuing therapy. In the first 8 weeks of therapy, a weekly count of the elements and, especially, platelets is needed.

If Recormon® is prescribed before fetching autologous donor blood, the recommendations for the donor procedure should be followed:

- blood can be taken only in patients with hematocrit ≥33% (or hemoglobin not less than 110 g / l (6.83 mmol / l);

- special caution should be observed in patients with a body weight of less than 50 kg;

- The volume of blood taken at one time should not exceed 12% of the estimated volume of the patient's blood.

It is possible to increase the number of platelets within the norm in patients receiving Recormon® before taking autologous donor blood, therefore the number of platelets should be monitored weekly. Treatment of Recormon® is interrupted when the platelets are increased by more than 150 · 109 / l or when thrombocytosis occurs.

Recormon® treatment is indicated only for those patients who are most important to avoid homologous blood transfusion, taking into account the risk-benefit ratio for homologous transfusion.

Perhaps a slight increase in the number of platelets in the prevention of anemia in preterm infants (up to 12-14 days), so regular monitoring of platelets is recommended.

The decision to use Recormon® in patients with nephrosclerosis who do not receive dialysis should be taken individually, It is impossible to completely exclude the possibility of a more rapid deterioration in kidney function.

In most cases, concomitantly with an increase in hemoglobin, the concentration of serum ferritin decreases. Therefore, all patients with anemia of renal genesis and with a serum ferritin concentration of less than 100 μg / l or a transferrin saturation of less than 20% are recommended to receive oral iron (Fe2 +) at a dose of 200-300 mg / day.

Patients with oncological and hematological diseases receive iron therapy according to the same principles, and patients with myeloma, non-Hodgkin's lymphomas or chronic lymphocytic leukemia with transferrin saturation less than 25% can be administered 100 mg of Fe3 + per week IV. For preterm infants, oral iron therapy at a dose of 2 mg of Fe2 + per day should be given as soon as possible (at the latest - on the 14th day of life). The dose of iron is corrected depending on the level of serum ferritin. If it persistently remains below 100 mcg / ml or there are other signs of iron deficiency, the dose of iron preparations should be increased to 5-10 mg / day and treatment should be performed until the symptoms of iron deficiency are relieved.

Patients with moderate anemia before the planned large-scale surgery, the drug is prescribed taking into account the benefits of epoetin beta and the increased risk of thromboembolic complications.

In patients who are preparing to donate blood for subsequent autotransfusion, because they have indications for temporary iron deficiency, oral therapy with iron (Fe2 +) preparations at a dose of 300 mg / day should begin simultaneously with Rekormon® therapy and continue until the ferritin index is normalized. If, despite oral iron replacement therapy, signs of iron deficiency develop (ferritin level ≤20 μg / L or transferrin saturation less than 20%), it is necessary to consider the question of additional intravenous iron preparations.

The solution of Recormon® in the cartridge contains benzyl alcohol as a preservative, which can cause neurological and other complications in neonates, which can sometimes be fatal.

Influence on the ability to drive and work with machinery. Studies to study the effect of the drug on the ability to drive and work with mechanisms were not carried out. Based on the mechanism of action and the safety profile, Recormon® does not have this effect.

Storage conditions of the drug Recormon

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Recormon

2 years.

Do not use after the expiry date printed on the package.

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