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Instruction for use: Binokrit
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Dosage form: Solution for intravenous and subcutaneous administration
Active substance: Epoetinum alfa
ATX
B03XA01 Erythropoietin
Pharmacological group:
Stimulators of hemopoiesis
The nosological classification (ICD-10)
B23.2 HIV disease, with manifestations of hematologic and immunological disorders, not elsewhere classified: Anemia in HIV-infected patients; Neutropenia in patients with AIDS
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 Chronic Renal Failure: Congestive Renal Failure; Renal failure chronic; Chronic Renal Failure; CRF; Chronic kidney failure in children
Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction
Z49 Aid that includes dialysis: Peritoneal dialysis; Peritoneal dialysis continuous; Peritoneal dialysis fractional
Z49.1 Aids that include extracorporeal dialysis: hemodialysis; Chronic hemodialysis; Extracorporeal circulation; Thrombosis of hemodialysis shunt
Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics
Composition
| Composition see table |
| Substance name | Solution for intravenous and subcutaneous administration (dosage) | ||||||||||
| 16,8 mkg/ml | 84 mkg/ml | 336 mkg/ml | |||||||||
| Number, IU / syringe (1 dose) | |||||||||||
| 1000 | 2000 | 3000 | 4000 | 5000 | 6000 | 8000 | 10000 | 20000 | 30000 | 40000 | |
| Active substance | |||||||||||
| Epoetin alfa1, IU (mkg) | 1000 (8,4) | 2000 (16,8) | 3000 (25,2) | 4000 (33,6) | 5000 (42) | 6000 (50,4) | 8000 (67,2) | 10000 (84) | 20000 (168) | 30000 (252) | 40000 (336) |
| Excipients | |||||||||||
| Sodium dihydrogen phosphate dihydrate, mg | 0,7 | 1,4 | 0,42 | 0,56 | 0,7 | 0,84 | 1,12 | 1,4 | 0,7 | 1,05 | 1,4 |
| Sodium hydrogen phosphate dihydrate, mg | 1,42 | 2,84 | 0,852 | 1,136 | 1,42 | 1,704 | 2,272 | 2,84 | 1,42 | 2,13 | 2,84 |
| Sodium chloride, mg | 2,19 | 4,38 | 1,314 | 1,752 | 2,19 | 2,628 | 3,504 | 4,38 | 2,19 | 3,29 | 4,38 |
| Glycine, mg | 2,5 | 5 | 1,5 | 2 | 2,5 | 3 | 4 | 5 | 2,5 | 3,75 | 5 |
| Polysorbate 80, mg | 0,15 | 0,3 | 0,09 | 0,12 | 0,15 | 0,18 | 0,24 | 0,3 | 0,15 | 0,23 | 0,3 |
| Hydrochloric acid 2, mg | 0,035 | 0,07 | 0,021 | 0,028 | 0,035 | 0,042 | 0,056 | 0,07 | 0,035 | 0,053 | 0,07 |
| Sodium hydroxide2, mg | 0,035 | 0,07 | 0,021 | 0,028 | 0,035 | 0,042 | 0,056 | 0,07 | 0,035 | 0,053 | 0,07 |
| Water for injection, ml | äî 0,5 | to 1 | to 0,3 | to 0,4 | to 0,5 | to 0,6 | to 0,8 | to 1 | to 0,5 | to 0,75 | to 1 |
Description of dosage form
Clear colorless solution.
Pharmachologic effect
Mode of action - Hematopoietic.
Pharmacodynamics
Erythropoietin is a glycoprotein that stimulates erythropoiesis, activates mitosis and maturation of erythrocytes from progenitor cells of the erythrocyte series. The molecular weight of erythropoietin is about 32,000-40000 Da. The protein fraction is about 58% of the molecular weight and includes 165 amino acids. The four hydrocarbon chains are linked to the protein by three N-glycosidic bonds and one O-glycosidic linkage. Epoetin alfa, obtained using genetic engineering technology, is a purified glycoprotein, it is identical in amino acid and carbohydrate composition to human erythropoietin isolated from urine in patients with anemia
Binokrit® has the highest possible degree of purification in accordance with modern technological capabilities. In particular, in the quantitative analysis of the active substance of Binokrit®, even the trace amounts of the cell lines on which the preparation is produced are not determined.
The biological activity of epoetin alfa was confirmed in an in vivo experiment (studies were conducted on healthy rats and rats with anemia, as well as in mice with polycythemia). After the administration of epoetin alfa, the number of erythrocytes, reticulocytes, hemoglobin concentration and absorption rate of 59Fe increase. In in vitro studies with incubation with epoetin alfa, an increase in incorporation of 3H-thymidine in erythroid nucleus-containing spleen cells (in mouse spleen cell culture) was found. Studies on the culture of human bone marrow cells have shown that epoetin alfa specifically stimulates erythropoiesis and does not affect leukopoiesis. The cytotoxic effect of erythropoietin on human bone marrow cells has not been revealed.
Erythropoietin is a growth factor, which mainly stimulates the formation of red blood cells. Receptors to erythropoietin may be present on the surface of various tumor cells.
The introduction of epoetin alfa is accompanied by an increase in hemoglobin, hematocrit, serum iron, improves blood supply to tissues and the work of the heart. The most significant effect of epoetin alfa has been observed in anemias caused by chronic renal insufficiency (CRF), and also developed in patients with a number of malignant neoplasms and systemic diseases.
Pharmacokinetics
IV introduction
T1 / 2 epoetin alfa after repeated intravenous administration is about 4 hours in healthy volunteers and about 5 hours in patients with chronic renal insufficiency. In children, T1 / 2 epoetin alfa is about 6 hours.
F / c introduction
With n / k introduction, the concentration of epoetin alfa in the blood plasma is determined to be significantly lower than with iv injection, Tmax epoetin alfa in blood plasma is about 12-18 hours after administration. Cmax epoetin alfa with n / k introduction is only 1/20 part of the concentration with the / in the introduction. The drug does not have the ability to cumulate - the concentration of epoetin alfa in the blood plasma after 24 hours after the first injection is determined the same as after 24 hours after the last injection. With n / to the introduction of T1 / 2 epoetin alfa is difficult to determine, it is about 24 hours. The bioavailability of epoetin alfa with p / k introduction is significantly lower than when it is in / in the introduction, and is about 20%.
Indications Binokrit
Anemia in adults and children due to chronic renal failure, including:
- anemia due to chronic renal failure in children and adults on hemodialysis, as well as in adults on peritoneal dialysis;
- severe anemia of renal genesis, accompanied by clinical symptoms in adults with renal failure who have not yet undergone hemodialysis;
Treatment of anemia and a reduction in the need for blood transfusion in adults receiving chemotherapeutic drugs for congenital malignancies, malignant lymphoma or multiple myeloma, as well as for people at high risk of complications of blood transfusion due to the general severe condition (due to cardiovascular diseases, If anemia was noted before chemotherapy was initiated);
With the aim of increasing the efficiency of autologous blood transfusion within the limits of the pre-surgical blood collection program before surgical operations in patients with a hematocrit level of 33-39% to facilitate the collection of autologous blood and reduce the risk associated with the use of allogeneic blood transfusions if the expected need for transfused blood exceeds The amount that can be obtained by autologous collection without the use of epoetin alfa. Treatment is indicated for patients with moderate anemia (hemoglobin concentration 10-13 g / dl or 6.2-8.1 mmol / L), without iron deficiency, if significant blood loss is suspected, as well as in extensive surgical interventions, when large Volume of transfused blood (5 or more volumes in men and 4 or more in women);
With the aim of reducing the risk for allogeneic blood transfusion in adults who do not have iron deficiency, before an elective orthopedic operation, in the presence of a high risk of complications during blood transfusions. The use of the drug is limited - only in patients with moderate anemia (for example, at a hemoglobin concentration of 1013 g / dl), if they are not included in the autologous blood collection program before the operation with the expected blood loss of 900 to 1800 ml;
Anemia in HIV-infected patients receiving zidovudine therapy, with an endogenous erythropoietin level of less than 500 IU / mL.
Contraindications
Hypersensitivity to the active substance and excipients included in the preparation;
Partial red cell aplasia (PKAA) that occurred after treatment with erythropoietin;
Uncontrolled arterial hypertension;
Patients who for some reason cannot receive effective treatment for the prevention of thrombosis;
Myocardial infarction or stroke that occurred within 1 month before the planned treatment; Unstable angina; Patients with a high risk of deep vein thrombosis and thromboembolic disease in the anamnesis (in the context of increasing the efficiency of autologous blood transfusion);
Severe lesions of coronary, peripheral arteries, carotid arteries, as well as cerebral vessels, incl. In patients who have recently undergone myocardial infarction or stroke (as part of a preshipter program for collecting blood before an extensive surgical operation and not participating in the autologous blood transfusion program).
With caution: malignant neoplasms, epileptic syndrome (including in the anamnesis), chronic renal and hepatic insufficiency, thrombocytosis, thrombosis (in the anamnesis), acute blood loss, sickle cell anemia, hemolytic anemia, iron, B12 or folic deficiency State.
Application in pregnancy and lactation
Appropriate controlled trials of the use of epoetin alfa in women during pregnancy have not been conducted. Based on animal studies, reproductive toxicity has been identified. Therefore, patients with CRF should use Binokrit® during pregnancy only if the intended benefit to the mother is significantly greater than the risk to the fetus.
The use of epoetin alfa is not recommended during pregnancy or lactation in patients participating in a program for collecting autologous blood before a surgical operation.
Side effects
The following side effects are distributed according to the classification of organs and systems and the frequency of occurrence: very often (≥1 / 10); Often (≥1 / 100- <1/10); Infrequently (≥1 / 1000- <1/100); Rarely (≥1 / 10000- <1/1000); Very rarely (<1/10000), the frequency is unknown (cannot be estimated from the available data).
From the blood and lymphatic system: infrequently - thrombocythemia (in patients with malignant neoplasms); Frequency unknown - PKAA mediated via antibodies1, thrombocythemia (in patients with CRF).
On the part of the immune system: the frequency is unknown - anaphylactic reaction, hypersensitivity.
From the nervous system: very often - headache (in patients with malignant neoplasms); Often - convulsions (in patients with CRF), headache (in patients with CRF); Infrequently - hemorrhagic stroke2, convulsions (in patients with malignant neoplasms); Frequency unknown - stroke2, hypertensive encephalopathy, transient ischemic attacks.
From the side of the organ of vision: the frequency is unknown - retinal thrombosis.
From the CVS: often - deep vein thrombosis of the lower extremities (in patients with malignant neoplasms); Increased blood pressure; Frequency is unknown - deep vein thrombosis of the lower extremities (in patients with CRF), arterial thrombosis, hypertensive crisis.
On the part of the respiratory system: often - thromboembolism of the pulmonary artery2 (in patients with malignant neoplasms); Frequency unknown - thromboembolism of the pulmonary artery2 (in patients with CRF).
From the digestive tract: very often - nausea; Often - diarrhea (in patients with neoplasms), vomiting; Infrequently - diarrhea (in patients with CRF).
From the skin and its appendages: often - skin rash; Frequency unknown - angioedema, urticaria.
From the musculoskeletal system: very often - arthralgia (with CRF); Often - arthralgia (in patients with malignant neoplasms); Infrequently - myalgia (in patients with malignant neoplasms); Frequency unknown - myalgia (with CRF).
Congenital, family / genetic disorders: frequency unknown - porphyria.
On the part of the body as a whole: very often - hyperthermia (in patients with malignant neoplasms); Influenza-like state (with CRF); Often - influenza-like condition (in patients with malignant neoplasms); Frequency unknown - ineffectiveness of the drug, peripheral edema, hyperthermia (with CRF), reactions at the site of administration.
Laboratory parameters: frequency unknown - antibodies to erythropoietin1.
Others: often - thrombosis shunt dialysis equipment (in patients with CRF)
1 Frequency of manifestations cannot be assessed on the basis of clinical studies.
2 Including fatal cases.
Interaction
There are no data on the interaction of epoetin alfa with other drugs. However, with simultaneous application with cyclosporin, interaction is possible, since the drug binds to erythrocytes. If Binokrit® is administered concomitantly with cyclosporine, the concentration of cyclosporine should be monitored, depending on the degree of hematocrit elevation.
There is no data on the interaction between epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte-monocyte colony-stimulating factor (GM-CSF).
To avoid incompatibility or decrease in activity, it is not recommended to mix with solutions and other medications.
Dosing and Administration
IV, SC.
Treatment with Binokrit® should be performed under the supervision of a specialist doctor who has the appropriate qualifications and experience in treating patients who are shown therapy with erythropoiesis stimulant drugs.
Doses
Treatment of symptomatic anemia in adults and children with CRF: Binocrit® in patients with CRF is administered IV. Due to the fact that the clinical manifestations of anemia and residual events may vary depending on the age, sex and overall severity of the disease, an individual assessment of the condition of each patient is carried out.
The target level of hemoglobin concentration is 10-12 g / dL (6.2-7.5 mmol / L) in adults and 9.5-11 g / dl (5.9-6.8 mmol / L) in children.
It is not recommended to prolong the hemoglobin concentration by more than 12 g / dl (7.5 mmol / l). If the hemoglobin concentration rises by more than 2 g / dl (1.25 mmol / L) per month or for a long time exceeds 12 g / dl (7.5 mmol / l), the dose of Binocrit® should be reduced by 25%. If the hemoglobin concentration exceeds 13 g / dl (8.1 mmol / L), it is necessary to stop treatment until hemoglobin is lowered to 12 g / dl (7.5 mmol / L) and then resume therapy with Binokrit®, reducing the initial dose by 25% .
Due to interindividual variability, the hemoglobin concentration may be higher or lower than the optimal (target) value.
Treatment should be prescribed in such a way that the minimally effective dose of Binocrit® provides the necessary control of hemoglobin and clinical manifestations of the disease.
Before the start of treatment and during the treatment should monitor the concentration of iron in the blood plasma, if necessary, prescribe an iron supplement.
Adult patients receiving hemodialysis
Treatment is carried out in two stages.
Correction phase. IV enter Binokrit® in a dose of 50 IU / kg 3 times a week. If necessary, the dose is adjusted gradually, within 4 weeks.
Increase or decrease of dose - no more than 25 IU / kg 3 times a week.
Stage of maintenance therapy. Correction of the dose in order to maintain the required level of hemoglobin 10-12 g / dl (6.2-7.5 mmol / l).
The recommended total weekly dose of Binokrit® is 75 to 300 IU / kg, I / O is administered 25-100 IU / kg 3 times a week.
In patients with severe anemia (hemoglobin <6 g / dL or <3.75 mmol / L), higher maintenance doses may be necessary than patients with a higher hemoglobin concentration (<8 g / dL or <5 mmol / L).
Use in children receiving hemodialysis
Treatment is carried out in two stages.
Correction phase. In / in enter Binokrit® in a dose of 50 IU / kg 3 times a week. If necessary, the dose is adjusted gradually, within 4 weeks. Increase or decrease of dose - no more than 25 IU / kg 3 times a week.
Stage of maintenance therapy. Correction of the dose in order to maintain the required level of hemoglobin 9.5-11 g / dl (5.9-6.8 mmol / l).
In most cases, children with a body weight of less than 30 kg should use higher maintenance doses than children with a higher body weight and adults.
According to available clinical data, during 6 months of treatment, the following dosages of the drug are appropriate depending on the body weight of patients:
| Body weight, kg | Dose, IU / kg 3 times a week | |
| Avarage | Supportive | |
| <10 | 100 | 75–150 |
| 10–30 | 75 | 60–150 |
| >30 | 33 | 30–100 |
Treatment is carried out in two stages.
Correction phase. The initial dose of 50 IU / kg 2 times a week in / in.
Stage of maintenance therapy. Correction of the dose in order to maintain the required level of hemoglobin 10-12 g / dl (6.2-7.5 mmol / l). The maintenance dose is 25 to 50 IU / kg 2 times a week, 2 equal injections.
Adults with renal failure who did not undergo dialysis
Treatment is carried out in two stages.
Correction phase. The initial dose is 50 IU / kg 3 times a week IV, followed by an increase of 25 IU / kg (3 times a week if necessary) until the target dose is reached. (Increase the dose gradually, for at least 4 weeks).
Stage of maintenance therapy. Correction of the dose in order to maintain the required level of hemoglobin 10-12 g / dl (6.2-7.5 mmol / l). The maintenance dose is from 17 to 33 IU / kg 3 times a week IV.
The maximum dose should not exceed 200 IU / kg 3 times a week.
Treatment of anemia in patients after chemotherapy
Binokrit® is administered sc (at hemoglobin concentration <10 g / dl (6.2 mmol / L), the dose is selected by the doctor taking into account the severity of anemia, age, sex and the overall severity of the patient's condition individually. Concentration of hemoglobin, correcting the applied dose of the drug, taking into account the normal values of hemoglobin concentration of 10 g / dL (6.2 mmol / l) - 12 g / dl (7.5 mmol / l). It is not recommended to exceed the hemoglobin concentration> 12 g / 7.5 mmol / l), recommendations for adjusting the dose in such cases Below.
Treatment should be prescribed in such a way that the minimum effective dose of epoetin alfa provides the necessary control of the symptoms of anemia.
Therapy with Binokrit® should be continued for 1 month after completion of the course of chemotherapy.
The initial dose of the drug is 150 IU / kg, is given p / to 3 times a week. Alternative use of the drug in a dose of 450 IU / kg p / c is possible once a week.
If the concentration of hemoglobin is increased by at least 1 g / dl (> 0.62 mmol / l) or the number of reticulocytes is increased to ≥ 400,000 cells / μl with respect to the initial indices after 4 weeks of treatment, the dose of the drug is 150 IU / kg 3 times a week or 450 IU / Kg once a week and remains unchanged.
If the concentration of hemoglobin is increased by <1 g / dl (<0.62 mmol / l) and the number of reticulocytes is increased <40,000 cells / μl relative to the initial indices, it is necessary to increase the dose to 300 IU / kg 3 times a week. If after 4 more weeks of treatment at a dose of 300 IU / kg 3 times a week the concentration of hemoglobin increases ≥1 g / dl (≥0.62 mmol / l) or the number of reticulocytes increases ≥40000 cells / μl, the dose should remain the same and 300 IU / kg 3 times a week. However, if the increase in hemoglobin concentration <1 g / dl (<0.62 mmol / l) and the increase in the number of reticulocytes <40,000 cells / μl relative to the initial parameters, therapy with Binokrit® is considered ineffective, it should be discontinued.
Recommended scheme of Binokrit®
| 150 IU / kg 3 times a week or 450 IU / kg once a week Within 4 weeks | |
| ò | ò |
| An increase in the number of reticulocytes ≥40000 cells / mm3 or an increase in hemoglobin ≥1 g / dL | An increase in the number of reticulocytes <40,000 cells / mm3 or an increase in hemoglobin <1 g / dL |
| ò | ò |
| Target hemoglobin (about 12 g / dL) | 300 IU / kg 3 times a week for 4 weeks |
| ñ | ! or $ |
| An increase in the number of reticulocytes ≥40000 cells / mm3 or an increase in hemoglobin ≥1 g / dL | |
| An increase in the number of reticulocytes <40,000 cells / mm3 or an increase in hemoglobin <1 g / dL | |
| ò | |
| Discontinuation of treatment | |
Dose adjustment to maintain the hemoglobin concentration within 10-12 g / dL
If the hemoglobin concentration rises by more than 2 g / dL (1.25 mmol / L) per month or the hemoglobin level exceeds 12 g / dl (7.5 mmol / l), it is necessary to reduce the dose of the drug by 25-50%. If the concentration of hemoglobin exceeds 13 g / dL (8.1 mmol / L), the treatment should be discontinued to 12 g / dL (7.5 mmol / L), and then resume epoetin alfa therapy by reducing the initial dose by 25 %.
Adult patients participating in the autologous blood collection program before surgical operations
Binokrit® is administered intravenously, after completing the blood donation procedure. Patients with mild anemia (at 33-39% hematocrit) who require> 4 blood units should be treated with Binokrit® at a dose of 600 IU / kg 2 times a week for 3 weeks before surgery.
All patients receiving Binokrit® should additionally be prescribed iron preparations (inside at a dose of 200 mg / day) throughout the course of therapy.
The use of the iron preparation should be prescribed before the initiation of therapy with Binocrit®, as early as possible, several weeks before the collection of autologous blood begins.
Adult patients who are subject to elective orthopedic surgery
Binokrit® is injected w / c.
The recommended dose of Binocrit® is 600 IU / kg once a week for 3 weeks preceding surgery (21, 14 and 7 days before surgery) and on the day of surgery. If the preoperative period is shorter than 3 weeks, Binocrit® should be given daily at a dose of 300 IU / kg for 10 consecutive days, before surgery, on the day of the operation and for 4 days after it. If the Hb concentration is 15 g / dl (9.38 mmol / L) or higher in the preoperative period, the drug should be discontinued. It should be ensured that before the start of treatment with Binocrit®, patients do not have iron deficiency.
All patients receiving Binocrit® should receive the required amount of ferrous iron (200 mg / d orally) throughout the course of therapy.
Method of administration
Binokrit® is a sterile, non-preservative preparation intended exclusively for single use.
You must enter the required amount of the drug. The drug should not be administered as an intravenous infusion or mixed with other drugs.
1. IV the injection. The duration of the injection is 1-5 min, depending on the total volume of the dose. With hemodialysis, a bolus injection can be used during the dialysis procedure through a convenient venous port in the dialysis line. An alternative may be an injection made at the end of the dialysis procedure through a fistula needle, then 10 ml of isotonic sodium chloride solution is added to clean the needle and ensure a satisfactory introduction of the drug into the bloodstream.
Patients with possible temperature reactions to IV injection of the drugs are advised to slowly administer the drug.
2. SC injection. Do not exceed the maximum injection volume - 1 ml per injection site. In the case of the introduction of large volumes, it is necessary to choose a greater number of injection sites. Injections are injected into the thigh muscle or anterior abdominal wall area.
Overdose
The therapeutic range of the drug is wide. In case of an overdose, there may be symptoms that reflect the extreme degree of manifestation of the pharmacological action of the hormone (increase in the concentration of hemoglobin or hematocrit). With exceptionally high levels of hemoglobin or hematocrit, the use of phlebotomy is possible. If necessary, symptomatic therapy is prescribed.
Special instructions
When administering Binokrit®, all patients should check and closely monitor BP. Caution should be taken with epoetin alfa in patients with hypertension if they do not receive the necessary treatment, the treatment is inadequate or hypertension is poorly controlled. In this case, it may be necessary to initiate or enhance antihypertensive therapy, which has already been applied. If normalization of blood pressure is not possible, treatment with epoetin alfa should be discontinued. Binokrit ® is used with caution in the presence of epilepsy and chronic liver failure.
Patients with CRF and cancer patients should regularly monitor the hemoglobin level until stable indicators are achieved and periodically thereafter.
Careful control of hemoglobin is mandatory for all patients due to the increased potential risk of thromboembolic complications and the increase in the number of fatal cases when patients received treatment at a hemoglobin level exceeding the established norm for the use of the drug according to indications.
During treatment with Binokrit®, a moderate dose-dependent increase in platelet count may be observed within normal limits. With the continuation of the course of therapy, this indicator again decreases. During the first 8 weeks after the start of therapy, it is recommended to regularly monitor the number of platelets.
Before the beginning of therapy it is necessary to exclude all other causes of anemia (iron deficiency, hemolysis, blood loss, vitamin B12 deficiency or folic acid). In most cases, serum ferritin levels decrease with a simultaneous increase in hematocrit.
All these additional factors of anemia should also be considered when increasing the dose of Binokrit® in patients with neoplasms.
In the perioperative period, you must carefully monitor all blood indicators.
PACA
After several months or years of treatment with erythropoietin with subcutaneous injections, the incidence of PKAA mediated through antibodies was very rare. If the effectiveness of therapy decreases dramatically due to a decrease in the concentration of hemoglobin (1-2 g / dL per month), the number of reticulocytes should be checked and the typical reasons for the lack of response to the drug (for example, deficiency of iron, folic acid or vitamin B12 , Intoxication with aluminum, infection or inflammation, bleeding or hemolysis).
If the content of reticulocytes is low (<20000 / mm3 or <20000 / μL or <0.5%), the number of platelets and leukocytes is normal and there is no other reason for the decrease in efficacy, it is necessary to determine the presence of antibodies to Erythropoietin and conduct a bone marrow examination to diagnose the PKAA.
If a PKAA mediated through antibodies to erythropoietin is suspected, Binocrit® therapy should be discontinued immediately. It is forbidden to prescribe any other therapy with erythropoietin because of the risk of a cross reaction. If there is evidence, patients may be given the necessary therapy, for example, blood transfusion.
In the case of a paradoxical decrease in hemoglobin concentration and development of severe anemia due to low reticulocyte content, it is necessary to immediately stop epoetin treatment and conduct a test for the presence of antibodies to erythropoietin. There are data on such manifestations in patients with hepatitis C who received treatment with interferon and ribavirin simultaneously with epoetin. Epoetin is not intended for the treatment of anemia due to hepatitis C.
Patients with CRF
Immunogenicity data for subcutaneous administration of Binocrit® to patients at risk of developing PKA mediated through antibodies, such as renal anemia, are limited. Therefore, in patients with renal anemia, the drug should be administered iv.
In order to minimize the risks of hypertension increase for patients with CRF, the rate of hemoglobin increase should be approximately 1 g / dL (0.62 mmol / L) per month and should not exceed 2 g / dL (1.25 mmol / L) per month.
In patients with CRF, the hemoglobin concentration in the maintenance phase of treatment should not exceed the VGN recommended in the section "Method of administration and dose". The results of clinical studies have shown an increased risk of fatal outcomes and severe cardiovascular disorders with the administration of erythropoiesis stimulating drugs in order to increase the hemoglobin concentration by more than 12 g / dl (7.5 mmol / l).
Clinical studies under controlled conditions showed no significant benefits associated with the use of epoetins against the background of an increase in the hemoglobin concentration above the level necessary to control the symptoms of anemia and prevent blood transfusions. Patients on hemodialysis had cases of shunt thrombosis, particularly with a tendency to hypotension or due to the formation of arteriovenous fistulas (eg, stenosis, aneurysm, etc.). Such patients are recommended early correction of the shunt and prophylaxis of thrombosis, for example with acetylsalicylic acid.
In some cases, hyperkalemia was observed. Treatment of anemia can lead to increased appetite and increased need for potassium and protein. Periodically, the dialysis schedule should be adjusted to maintain the required urea, creatinine and potassium indices. In patients with CRF, it is necessary to check the content of electrolytes in the blood serum. If an elevated (or increasing) serum potassium level is detected, the expediency of abolishing epoetin alfa treatment before the normalization of the potassium level should be assessed. During treatment with epoetin alfa, an increase in the dose of heparin is often required in hemodialysis due to an increase in the hematocrit number. If heparinization cannot be as effective as possible, it may be necessary to cancel the scheme of dialysis procedures.
According to available data, treatment of anemia with epoetin alfa in adult patients with renal insufficiency, which is not yet undergoing dialysis, does not cause progression of renal failure.
Adult oncological patients with symptomatic anemia undergoing chemotherapy
In some clinical situations, blood transfusion should be used to treat anemia in patients with oncological diseases. The decision on the appointment of recombinant erythropoietins should be taken, given the correlation of the benefits and possible risks for each patient individually and the particularities of the clinical situation. The following factors should be considered: the type and stage of development of the neoplasm; The degree of anemia; Life expectancy; The situation in which the patient will be treated; Wishes of the patient.
When evaluating the feasibility of epoetin alfa therapy (the risk of blood transfusion for a patient) in cancer patients receiving chemotherapy, it is necessary to take into account the delay of 2-3 weeks after the administration of epoetin alfa to the formation of erythrocytes against the background of stimulation with erythropoietin.
In order to minimize the risk of thrombotic events, it is necessary to ensure that the hemoglobin level and the rate of its increase do not exceed the permissible values.
Due to the increase in the number of cases of venous thrombotic complications in oncological patients receiving erythropoiesis-stimulating drugs, such risk and benefit from epoetin alfa treatment should be carefully evaluated, especially in cancer patients with an increased risk of venous thrombotic complications, for example obesity or venous thrombotic diseases in the family History (including deep venous thrombosis or thromboembolism of the pulmonary artery).
Adult patients participating in the autologous blood collection program before surgical operations
It is necessary to comply with all the special precautions related to carrying out programs to collect autologous blood, especially with regular blood transfusions.
Patients subject to elective orthopedic surgery
For patients subject to elective orthopedic surgery, it is necessary to establish the cause of anemia and, if possible, cure anemia before starting epoetin alfa therapy. Such patients may have a risk of developing thrombotic events, which must be carefully evaluated when prescribing treatment for patients in this group.
Patients subject to elective orthopedic surgery should receive adequate antithrombotic prophylaxis due to the risk of developing venous thrombotic complications in surgical patients, especially those suffering from cardiovascular diseases. In addition, special precautions should be taken in patients with a predisposition to developing deep vein thrombosis. Patients with an initial hemoglobin level> 13 g / dl (> 8.1 mmol / L) increased the risk of postoperative thrombotic / venous complications. Therefore, the drug should not be administered to patients with an initial hemoglobin level> 13 g / dL (> 8.1 mmol / L).
Excipients
This drug contains less than 1 mmol sodium (23 mg) in one pre-filled syringe, i.e. Actually does not contain sodium.
Impact on the ability to manage vehicles and mechanisms. Binocrit® does not affect the ability to drive vehicles or work with machinery.
Release form
Solution for intravenous and subcutaneous injection, 16.8 μg / ml (1000 IU / 0.5 ml, 2000 IU / ml); 84 ug / ml (3000 IU / 0.3 ml of 4000 IU / 0.4 ml, 5,000 IU / 0.5 ml of 6000 IU / 0.6 ml of 8000 IU / 0.8 ml 10,000 IU / ml) , 336 mkg / ml (20,000 IU / 0.5 mL, 30,000 IU / 0.75 mL, 40,000 IU / mL).
0.5 ml (1000 ME) or 1 ml (2000 ME) solution in w / w and s / c administration of 16.8 mg / mL, 0.3 mL (3000 ME), 0.4 ml (4.000 ME) 0.5 ml (5000 ME), 0.6 mL (6000 ME), 0.8 mL (8000 ME) or 1 ml (10,000 ME) solution in w / w and s / c administration of 84 mkg / ml 0 5 ml (20000 ME), 0.75 ml (30000 ME) or 1 ml (40,000 ME) solution in w / w and s / c administration of 336 .mu.g / ml single-dose graded (with the scale division of 0.1 ml) syringes transparent colorless borosilicate glass type 1 (Eur. F.) it provided with a piston-rod of polypropylene brombutilkauchukovym sealant coated fluoropolymer, and an injection needle of stainless steel 27 14 G × rubber Unlim eksnym protective cap and the outer cap of polypropylene (to prevent blunting of the needle), as well as special safety cap for the needle after the injection (to prevent traumatization due needlesticks by negligence) or without it.
1 or 3 syringes are placed in a contour pack of transparent colorless plastic sheet (correx) and sealed with a transparent film. For 1 correction with 1 syringe or 2 correlations with 3 syringes placed in a cardboard box.
Manufacturer
Ai Dee Tee Biologie GmbH, Am Farmpark 06861 Dessau-Rosslau, Germany.
Issued quality control: Sandoz GmbH, Biohemistraße 10, A-6250 Kundl, Austria.
The legal entity in whose name the registration certificate was issued: Sandoz GmbH.
To obtain additional information about the preparation, as well as to forward your claims and information about undesirable phenomena, you can go to the following address in Russia: ZAO Sandoz, Russia. Moscow
Conditions of supply of pharmacies
On prescription.
Storage conditions of the drug Binokrit
At a temperature of 2-8 ° C (do not freeze).
Keep out of the reach of children.
Shelf life of the drug Binokrit
2 years.
Do not use after the expiry date printed on the package.
