Enixum - Instructions For Use, Price, Reviews, Solution Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Enixum

Enixum: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Enixum

ATX code: B01AB05

Active ingredient: Enoxaparin sodium (Enoxaparin sodium)

Producer: Sotex PharmFirma (Russia)

Description and photo update: 28.11.2018

Prices in pharmacies: from 2982 rubles.

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Enixum is a direct-acting drug that inhibits the activity of the blood coagulation system and prevents the formation of blood clots (anticoagulant).

Release form and composition

Enixum is produced in the form of a solution for injection: a clear liquid from colorless to yellowish or brownish-yellowish [in glass syringes, complete with a needle (a needle protection device may be present): 1 or 2 sets in a contour cell package, in a cardboard box 1 or 5 packages; in colorless glass ampoules with a colored break ring / colored dot and a notch (it is possible to additionally apply one, two or three colored rings and / or a two-dimensional barcode / alphanumeric coding to the ampoules): 1 or 5 ampoules in a contour cell package, in a pack of cardboard 1 or 2 packages; 2 ampoules in a blister strip package, in a cardboard box 1 package; each pack also contains instructions for the use of Enixum. Solution volume in each syringe: 2000 anti-Xa IU - 0.2 ml, 3000 anti-Xa IU - 0.3 ml,4000 anti-Ha IU - 0.4 ml, 5000 anti-Ha IU - 0.5 ml, 6000 anti-Ha IU - 0.6 ml, 7000 anti-Ha IU - 0.7 ml, 8000 anti-Ha IU - 0.8 ml, 10,000 anti-Ha IU - 1 ml].

The composition of the solution in 1 syringe:

• active substance: enoxaparin sodium - 20 mg (2000 anti-Ha ME), 30 mg (3000 anti-Ha ME), 40 mg (4000 anti-Ha ME), 50 mg (5000 anti-Ha ME), 60 mg (6000 anti-Ha IU), 70 mg (7000 anti-Ha IU), 80 mg (8000 anti-Ha IU), or 100 mg (10,000 anti-Ha IU);
• auxiliary component: water for injection.

Pharmacological properties

Pharmacodynamics

The active ingredient of Enixum is sodium enoxaparin, which is a low molecular weight heparin, a direct anticoagulant. The average molecular weight is approximately 4500 daltons: 68% - 2000-8000 daltons, <18% - more than 8000 daltons. The substance is obtained by alkaline hydrolysis of heparin benzyl ester isolated from the mucous membrane of the porcine small intestine. The structure of enoxaparin is characterized by a reducing 2-N, 6-O-disulfo-B-glucopyranoside fragment and a non-reducing 2-O-sulfo-4-enpyrazinosuronic acid fragment. The structure of the substance contains 15–25% (on average 20%) of the 1,6-anhydroderivative in the reducing fragment of the polysaccharide chain.

In vitro, enoxaparin sodium has high activity against coagulation factor Xa (anti-Xa activity about 100 IU / ml) and low activity against clotting factor IIa (anti-IIa or antithrombin activity about 28 IU / ml). The anticoagulant activity of the drug is mediated by antithrombin III (AT-III). In addition, enoxaparin revealed additional anticoagulant and anti-inflammatory activity, manifested in both animal and human models: a decrease in the release of von Willebrand factor into the bloodstream from the vascular endothelium and AT-III dependent inhibition of other coagulation factors (for example, factor VIIa), activation of the release tissue factor pathway inhibitor).

The described factors determine the anticoagulant effect of Enixum in general.

Anti-IIa activity reaches its maximum on average within 3-4 hours after subcutaneous (s / c) administration of Enixum and amounts to: 0.13 IU / ml - after administration of 1 mg / kg of body weight; 0.19 IU / ml - after administration of 1.5 mg / kg of body weight.

The maximum anti-Xa activity of plasma is achieved on average within 3-5 hours and after SC administration of Enixum at a dose of 20 or 40 mg, respectively, 0.2 or 0.4 IU / ml, at a dose of 1 or 1.5 mg / kg, respectively, 1 or 1.3 IU / ml.

In prophylactic doses, enoxaparin changes the activated partial thromboplastin time (APTT) to an insignificant extent. Almost does not affect platelet aggregation and the degree of binding to their fibrinogen receptors.

Pharmacokinetics

The pharmacokinetics of enoxaparin used in therapeutic doses is linear. Individual differences between patients are minimal.

After a single subcutaneous injection of a dose of 1 mg / kg, the maximum concentration (Cmax) is observed within 3.19 ± 1.08 hours and is 0.49 ± 0.07 IU / ml. The area under the concentration-time curve (AUC) is 4.44 ± 0.91 IU × ml / h.

Parameters assessed on the basis of anti-Xa activity: bioavailability - almost 100%, volume of distribution (Vd) - 5 liters, which is close to blood volume.

According to the literature, after repeated administration of Enixum, 40 mg once a day and at a dose of 1.5 mg / kg once a day, the equilibrium concentration (Css) is reached by the second day, while the AUC is about 15% higher than with single administration. After repeated injections of enoxaparin, 1 mg / kg 2 times a day, Css is achieved within 3-4 days, AUC is 65% higher compared with a single administration.

Enoxaparin is characterized by low clearance. The average plasma clearance of anti-Xa after intravenous (i / v) administration over a 6-hour dose of 1.5 mg / kg is 0.74 l / h.

The predominant way of metabolism of enoxaparin sodium is desulfation and / or depolymerization in the liver, as a result of which low molecular weight substances with very weak biological activity are formed.

The drug is excreted in several phases. After a single subcutaneous injection, the half-life is 4 hours, after repeated use - 7 hours. Approximately 10% of the received dose of Enixum is excreted in the form of active fragments through the kidneys. The total elimination of active and inactive fragments is about 40% of the administered dose.

In patients with reduced renal function, substance clearance decreases. After repeated subcutaneous administration of 40 mg of Enixum 1 time per day, there is an increase in anti-Xa activity, represented by AUC in mild and moderate renal failure (creatinine clearance, respectively, 50–80 ml / min and 30–50 ml / min). In severe renal failure (creatinine clearance <30 ml / min), the steady state AUC is approximately 65% higher with repeated administration of the drug at a daily dose of 40 mg.

Due to the physiological decrease in renal function in elderly patients, the elimination of enoxaparin is slowed down. If renal function is slightly reduced, there is no need to adjust the dosage regimen of Enixum during preventive therapy.

In patients with overweight and low body weight, the clearance of the drug changes.

If the dose is not adjusted depending on the patient's weight, after a single subcutaneous injection of 40 mg of Enixum, the anti-Xa activity will be higher: in women with a body weight of <45 kg - by 50%, in men with a body weight <57 kg - by 27 % in comparison with patients with normal average body weight.

Indications for use

Preventive use of Enixum:

• venous thrombosis and embolism during surgical interventions, especially general surgical and orthopedic;
• venous thrombosis and embolism in immobilized patients due to acute therapeutic diseases, including acute heart failure, decompensated chronic heart failure (NYHA functional class III or IV), acute respiratory failure, acute infectious diseases, acute stages of rheumatic diseases, in combination with any risk of developing venous thrombosis;
• thrombus formation in the extracorporeal circulatory system during hemodialysis (as a rule, with a session duration of no more than 4 hours).

The use of Enixum for medicinal purposes:

• deep vein thrombosis (with or without pulmonary embolism);
• acute myocardial infarction with ST-segment elevation if drug treatment or subsequent percutaneous coronary intervention is required;
• unstable angina and myocardial infarction without Q wave (in combination with acetylsalicylic acid).

Contraindications

• active extensive bleeding or the presence of a disease accompanied by a high risk of its development: dissecting aortic aneurysm or cerebral aneurysm (with the exception of surgery for this disease), recent hemorrhagic stroke, uncontrolled bleeding, threatened abortion, thrombocytopenia in the case of a positive test for antiplatelet antibodies in the presence of enoxaparin sodium in vitro;
• age up to 18 years;
• individual hypersensitivity to any component in Enixum or heparin / its derivatives, including other low molecular weight heparins.

In the following conditions with a potential risk of bleeding, Enixum should be used with caution:

• simultaneous use of drugs that affect the hemostatic system;
• hemostasis disorders, including hypocoagulation, thrombocytopenia, hemophilia, hereditary von Willebrand factor deficiency (von Willebrand disease);
• a history of heparin-induced thrombocytopenia, including in combination with thrombosis;
• renal / hepatic impairment;
• hemorrhagic / diabetic retinopathy;
• severe diabetes mellitus;
• severe arterial hypertension, not amenable to adequate control;
• pericardial inflammation, pericardial effusion;
• acute and subacute endocarditis of bacterial etiology;
• a recent history of ischemic stroke;
• severe vasculitis;
• the need for spinal / epidural anesthesia;
• lumbar puncture performed in the recent past;
• peptic ulcer / duodenal ulcer, other erosive and ulcerative lesions of the gastrointestinal tract in history;
• recent or planned neurological or ophthalmic surgery;
• the use of intrauterine contraception;
• childbirth in the recent past;
• severe trauma or large open wounds.

With active tuberculosis, as well as after recent radiation therapy, there are no data on the clinical use of Enixum.

Enixum, instructions for use: method and dosage

Enixum solution is injected deeply s / c, except in special cases. Intramuscular administration of the solution is prohibited.

The injections are performed with the patient lying down. The solution should be injected alternately into the right / left anterolateral or posterolateral surface of the abdomen.

The entire needle is inserted vertically (not from the side) into the skin fold between the thumb and forefinger and held until the injection is complete. It is not necessary to massage the injection site.

Prevention of thrombus formation in the extracorporeal circulatory system during hemodialysis

The average dose of Enixum is 1 mg / kg. If there is a high risk of bleeding, the dose is reduced to 0.75 mg / kg with a single vascular access, to 0.5 mg / kg with a double vascular access.

For patients on hemodialysis, the drug is injected into the arterial site of the shunt at the beginning of the session. One dose is usually sufficient for a 4 hour session. However, if fibrin rings are found during a longer hemodialysis session, if necessary, Enixum is additionally administered at a dose of 0.5–1 mg / kg.

Prevention of venous thrombosis and embolism in immobilized patients with acute therapeutic diseases

Enixum is usually prescribed 40 mg once a day for 6-14 days until the patient is transferred to an outpatient regimen.

Prevention of venous thrombosis and embolism during surgical operations

With a moderate risk of embolism / thrombosis (for example, in the case of an abdominal operation), Enixum is usually prescribed 20 mg once a day. The first injection is given 2 hours before surgery.

With a high risk of embolism and thrombosis (for example, during orthopedic interventions, surgical operations in oncology, as well as the presence of concomitant risk factors not related to surgery, such as varicose veins of the lower extremities, congenital or acquired thrombophilia, a history of venous thrombosis, malignant neoplasm, pregnancy, obesity, immobilization for more than 3 days) Enixum is used at 40 mg once a day, the first dose is administered 12 hours before the operation. An alternative dosage regimen: 30 mg 2 times a day, in this case the first dose is administered 12-24 hours after surgery.

The duration of anticoagulant therapy is on average 7-10 days. It is possible to increase the duration of treatment as long as the risk of embolism / thrombosis remains and until the patient is transferred to an outpatient regimen.

In orthopedic operations, after the end of the initial therapy, a maintenance course may be required: 40 mg 1 time per day for 3 weeks.

Treatment of unstable angina and non-Q-wave myocardial infarction

The dose of Enixum is 1 mg / kg. The drug is administered every 12 hours. At the same time, acetylsalicylic acid is prescribed, 100–325 mg orally once a day.

An anticoagulant should be used until the patient's condition stabilizes, usually up to 8 days, but at least 2 days.

Deep Vein Thrombosis Treatment

Depending on the clinical picture, Enixum is prescribed at 1.5 mg / kg 1 time per day or 1 mg / kg 2 times a day. For complicated thromboembolic disorders, a dosing regimen is recommended 2 times a day.

The average course of therapy is 10 days. The patient is immediately prescribed oral anticoagulants, and the subcutaneous administration of Enixum is continued until the required anticoagulant effect is achieved (assessed by anti-Xa activity), that is, until the INR (International Normalized Ratio) is 2–3.

Treatment of ST-segment elevation myocardial infarction

The first dose of Enixum, 30 mg, is given as a bolus IV. No later than 15 minutes, the second dose of s / c is administered, equal to 1 mg / kg (in the first two injections, it is allowed to use no more than 100 mg of enoxaparin sodium). In the future, the drug is used at a dose of 1 mg / kg and administered s / c at intervals of 12 hours (in patients weighing more than 100 kg, the dose of Enixum may exceed 100 mg).

Patients over 75 years of age are prohibited from the initial bolus IV administration of the drug. Enixum is used subcutaneously at 0.75 mg / kg every 12 hours (in the first two injections, it is allowed to use no more than 75 mg of enoxaparin sodium). Subsequently, at 12-hour intervals, a dosage of 0.75 mg / kg is observed, i.e., with a body weight of more than 100 kg, the dose may exceed 75 mg.

If Enixum is used in combination with thrombolytics (fibrin-specific and fibrin-nonspecific), enoxaparin is administered in the period from 15 minutes before the start of thrombolytic therapy up to 30 minutes after it.

As soon as the diagnosis of acute myocardial infarction with ST-segment elevation is confirmed, you should simultaneously start taking acetylsalicylic acid in a daily dose of 75–325 mg and continue to use it for at least 30 days (if there are no contraindications).

The duration of application of Enixum is 8 days or until the patient is discharged from the hospital if the duration of hospitalization was less than 8 days.

Bolus IV administration of the drug is carried out through a venous catheter. Enoxaparin sodium should not be mixed with other drugs and administered simultaneously with other solutions. To avoid drug interactions, before and after the introduction of Enixum, the venous catheter should be thoroughly rinsed with 0.9% sodium chloride solution or 5% dextrose solution - only these solutions are compatible with Enoxaparin.

For bolus administration of Enixum at a dose of 30 mg, an excess amount of solution is removed from the syringes so that only 0.3 ml remains. For this purpose, syringes with a volume of 60, 80 or 100 mg are used. 20 mg syringes are not suitable because they contain a lower dose, and 40 mg syringes are not suitable because they do not have graduations to measure the exact dose.

With percutaneous coronary intervention, if the last dose of Enixum was administered less than 8 hours before the balloon catheter inserted into the narrowing of the coronary artery was inflated, an additional dose is not required. If more than 8 hours have passed, an additional intravenous bolus dose of 0.3 mg / kg is required.

To increase the accuracy of dosing the drug for the purpose of additional injection into the venous catheter during percutaneous coronary interventions, it is recommended to dilute the solution to a concentration of 3 mg / ml immediately before use. For this, a part of the solution is removed from the container with the infusion solution using a conventional syringe and the required amount of enoxaparin sodium is injected here. If it is necessary to administer 0.3 ml of enoxaparin, 10 ml of infusion solution is left in the container, for a dose of 0.6 ml - 20 ml of solution. After mixing, the container is carefully mixed, the required amount of the diluted solution is removed from there, the volume of which is calculated by the formula "Volume of the diluted solution = Patient's body weight (kg) × 0.1", you can also use the data below.

Patient body weight: required dose; the required volume of a diluted solution with a concentration of 3 mg / ml:

• 45 kg: 13.5 ml; 4.5 ml;
• 50 kg: 15 ml; 5 ml;
• 55 kg: 16.5 ml; 5.5 ml;
• 60 kg: 18 ml; 6 ml;
• 65 kg: 19.5 ml; 6.5 ml;
• 70 kg: 21 ml; 7 ml;
• 75 kg: 22.5 ml; 7.5 ml;
• 80 kg: 24 ml; 8 ml;
• 85 kg: 25.5 ml; 8.5 ml;
• 90 kg: 27 ml; 9 ml;
• 95 kg: 28.5 ml; 9.5 ml;
• 100 kg: 30 ml; 10 ml.

Treatment of patients with concomitant renal impairment

In mild and moderate forms of renal failure (creatinine clearance 30–80 ml / min), dose adjustment is not required, but treatment should be carried out under close medical supervision.

In patients with severe impairment of renal function (creatinine clearance <30 ml / min), the duration of action of enoxaparin sodium increases, therefore the dose of the drug is reduced. When using Eniksum for therapeutic purposes, if a dose of 1 mg / kg is required 2 times a day with healthy kidney function, 1 mg / kg is administered once a day; if a dose of 1.5 mg / kg once a day is required for healthy kidney function, 1 mg / kg is administered once a day.

Treatment of acute ST-segment elevation myocardial infarction in severe renal impairment, depending on the patient's age:

• <75 years: i / v bolus 30 mg + s / c 1 mg / kg (but not more than 100 mg), then - 1 mg / kg once a day;
• ≥ 75 years: without an initial bolus of 1 mg / kg subcutaneous injection once a day (the first dose should not exceed 100 mg).

When using the Enixum solution for prophylactic purposes, it is prescribed (with the exception of hemodialysis sessions) n / a 20 mg once a day.

Side effects

Possible side effects from the blood coagulation system:

• very often (≥ 1/10) - thrombocytosis in the treatment of deep vein thrombosis (including thromboembolism) and prevention of venous thrombosis in surgical patients; the occurrence of bleeding, especially in patients with concomitant risk factors such as renal failure, organic changes with a tendency to bleeding, low body weight, old age, concomitant use of certain drugs - bleeding in deep vein thrombosis (including thromboembolism), in surgical patients, in the prevention of venous thrombosis;
• often (from ≥ 1/100 to <1/10) - thrombocytopenia in the treatment of myocardial infarction with ST segment elevation and deep vein thrombosis (with or without thromboembolism), in the prevention of venous thrombosis in surgical patients; bleeding in the treatment of angina pectoris, myocardial infarction with ST segment elevation and myocardial infarction without Q wave, in the prevention of venous thrombosis in patients with bed rest;
• infrequently (from ≥ 1/1000 to <1/100) - thrombocytopenia with myocardial infarction without Q wave and angina pectoris, with the prevention of venous thrombosis in immobilized patients; bleeding in ST-segment elevation myocardial infarction, intracranial bleeding and retroperitoneal bleeding in patients with deep vein thrombosis (with and without thromboembolism);
• rarely (from ≥ 1/10 000 to <1/1000) - bleeding in the treatment of angina pectoris and myocardial infarction without Q wave, retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients;
• very rarely (<1/10 000) - autoimmune thrombocytopenia in myocardial infarction with ST segment elevation, autoimmune thrombocytopenia with thrombosis; in some cases, thrombosis is complicated by limb ischemia or organ infarction; against the background of spinal / epidural anesthesia and postoperative use of penetrating catheters - the formation of spinal epidural hematomas due to neuraxial blockades, which lead to neurological disorders of varying severity, including long-lasting and even irreversible paralysis.

Other side reactions:

• very often - increased activity of hepatic transaminases;
• often - redness of the skin, itching, urticaria, pain and bruising at the injection site, allergic reactions;
• infrequently - bullous skin rashes, purpura, inflammatory reactions and the formation of solid inflammatory nodules (infiltrates) at the injection site, as well as painful erythematous papules, leading to skin necrosis at the injection site;
• rarely - hyperkalemia, anaphylactoid and anaphylactic reactions.

Overdose

An overdose of Eniksum is manifested by hemorrhagic complications. In case of accidental ingestion of the drug inside, regardless of the dose, absorption of the drug is unlikely.

The effect of enoxaparin sodium is neutralized by slow intravenous administration of protamine sulfate: if no more than 8 hours have passed since the introduction of Enixum, the dose of protamine sulfate is determined at the rate of 1 mg per 1 mg of enoxaparin sodium; if more than 8 hours have passed or the introduction of a second dose is necessary, 0.5 mg of protamine sulfate per 1 mg of enoxaparin sodium is administered; if more than 12 hours have passed, there is no need to introduce protamine sulfate. Even with the use of high doses of protamine sulfate, the anti-Xa activity of Enixum is not completely neutralized (up to 60%).

special instructions

Low molecular weight heparins are not interchangeable, since they differ in specific anti-Xa activity, molecular weight, dosage units, manufacturing process and dosage regimen, and therefore, in biological activity and pharmacokinetics. In this regard, it is important to strictly follow the doctor's recommendations for the use of each drug.

Like any anticoagulant, Enixum contributes to the risk of bleeding of arbitrary localization. If bleeding occurs, a thorough medical examination is required to identify its source and appropriate treatment.

Patients receiving medications affecting hemostasis should discontinue them before using Enixum, except in cases of urgent need. Then careful clinical observation and monitoring of appropriate laboratory parameters are required.

The risk of bleeding increases with insufficient body weight: in women - less than 45 kg, in men - less than 57 kg. This is due to an increase in the exposure of enoxaparin sodium.

Obese patients are more likely to develop embolism and thrombosis. The safety, as well as the effectiveness, of Enixum when used for prophylactic purposes in obese patients (body mass index> 30 kg / m ²) have not been fully determined. There is no consensus among medical specialists on the correction of the dosage regimen. In this regard, patients with overweight during the period of therapy should be carefully monitored for the development of embolism and thrombosis.

With the use of low molecular weight heparins, there is a risk of developing antibody-mediated HIT (heparin-induced thrombocytopenia), which is usually detected on days 5-21 of the course. For this reason, it is necessary to regularly monitor the number of platelets in the peripheral blood, both before the start of the administration of Enixum, and during treatment. If the platelet count is 30–50% lower than baseline, anticoagulant therapy is promptly discontinued and alternative treatment is prescribed.

Enixum should be used with extreme caution in patients with a history of information on the development of heparin-induced thrombocytopenia. The risk of its development can persist for several years. If history suggests heparin-induced thrombocytopenia, in vitro platelet aggregation test results are of limited value in predicting the risk of recurrence. The decision on the advisability of using enoxaparin sodium is made only by a doctor.

It is recommended to insert and remove the catheter if the anticoagulant effect is low. However, it should be borne in mind that the exact time required for a sufficient decrease in the anticoagulant effect has not been established, therefore, the installation / removal of the catheter should be carried out at least 12 hours after the administration of lower doses of Enixum (20 mg once a day, or 30 mg 1-2 times a day). day, or 40 mg 1 time per day), 24 hours after the introduction of higher doses of Enixum (0.75 mg / kg 2 times a day, or 1 mg / kg 2 times a day, or 1.5 mg / kg 1 once a day). During these periods, anti-Xa activity continues to be detected, so time delays do not guarantee that the development of neuraxial hematoma will be avoided.

Patients who are injected with Enixum 2 times a day should not use a second dose to increase the interval before installing / replacing the catheter.

After removal of the catheter, it is also recommended to delay the administration of the next dose of enoxaparin sodium for at least 4 hours, due to the likelihood of bleeding during the procedure and thrombosis (especially in the presence of risk factors). However, there are no clear recommendations for the next dose of the drug.

It should be borne in mind that with creatinine clearance <30 ml / min, the excretion of enoxaparin slows down. In this regard, it may be advisable to increase the time from the moment of catheter removal by half: at least up to 24 hours - when using lower doses of Enixum (30 mg once a day), at least up to 48 hours - when using higher doses (1 mg / kg per day).

There are known cases of neuraxial hematomas occurring against the background of simultaneous spinal / epidural anesthesia, which led to the development of prolonged and even irreversible paralysis. The risk increases with increasing the dose of Enixum, as well as with the use of indwelling catheters after surgery and with the simultaneous use of drugs that affect hemostasis (for example, non-steroidal anti-inflammatory drugs). A risk factor is also a traumatic or repeated lumbar puncture in patients who have a history of spinal deformity or previous surgery in the spine. To reduce the risk of bleeding due to the use of an anticoagulant during epidural / spinal anesthesia / analgesia, the pharmacokinetic profile of enoxaparin sodium must be considered.

In the treatment of acute ST-segment elevation myocardial infarction, myocardial infarction without Q wave, and unstable angina pectoris, to minimize the risk of bleeding, percutaneous coronary angioplasty can be performed only in the intervals between Enixum injections to achieve hemostasis after invasive vascular instrumental manipulation. The femoral artery sheath can be removed immediately using the closure device. When manual compression is applied, the introducer can only be removed 6 hours after the last injection of Enixum. If treatment with enoxaparin is continued, the next dose is administered at least 6-8 hours after removal of the introducer sheath. The insertion site of the device must be constantly monitored in order to identify possible bleeding and hematoma formation in time.

If anticoagulant therapy is used during a lumbar puncture or epidural / spinal anesthesia, the patient should be under constant supervision in order to detect possible neurological symptoms in time, such as back pain, dysfunction of the bladder, impaired sensory and motor functions (weakness, numbness in lower extremities), functional bowel disorder. Patients should be warned about the need for immediate medical attention if any of the described symptoms occur. If a spinal cord hematoma is suspected, urgent diagnosis and treatment is required, and, if necessary, decompression of the spinal cord.

With the development of acute rheumatic conditions or acute infection, the use of Enixum for prophylactic purposes is justified only if there is one of the following risk factors for the development of venous thrombosis: chronic respiratory failure, heart failure, thrombosis and embolism in history, malignant neoplasms, concomitant hormonal therapy, obesity, age over 75 years.

In prophylactic doses prescribed to prevent thromboembolic complications, Enixum does not significantly affect blood coagulation parameters, bleeding time, platelet aggregation and their binding to fibrinogen. With an increase in the dose of the drug, it is possible to lengthen the APTT and the activated blood clotting time. An increase in these parameters does not have a direct linear relationship with an increase in the anticoagulant activity of enoxaparin, so there is no need to monitor them.

Information on the use of Enixum for the prevention of thrombosis in patients with mechanical artificial heart valves is limited. There is information about the development of heart valve thrombosis during prophylactic therapy with enoxaparin. It is not possible to accurately assess this information, since there are no clinical data, and patients have other factors that can contribute to the development of thrombosis of the heart valves, including the underlying disease.

Information on the use of Enixum for the prevention of thrombosis and embolism in pregnant women with mechanical artificial heart valves is limited. In a clinical study, enoxaparin sodium was used at 1 mg / kg 2 times a day. Two out of eight women developed blood clots, which led to blockage of the heart valves, resulting in the death of the mother and fetus.

Influence on the ability to drive vehicles and complex mechanisms

There is no evidence of a negative effect of Enixum on psychomotor and cognitive functions of a person.

Application during pregnancy and lactation

In preclinical studies, no teratogenic effect of enoxaparin on the fetus was revealed. There is no clinical experience with the drug in pregnant women, and adequate and fully controlled studies have not been conducted. There is no information on the penetration of the substance through the placental barrier. Animal studies do not always predict correctly the response to the use of enoxaparin sodium during pregnancy in humans. In this regard, Enixum can be prescribed only if the effect of the benefits of therapy is expected to outweigh the possible risks.

Whether unchanged enoxaparin sodium is excreted in breast milk is unknown, absorption of the substance from the gastrointestinal tract in a newborn is unlikely. However, as a precautionary measure, women are advised to interrupt breastfeeding during therapy.

Pediatric use

Enixum is not used in pediatrics, since there is insufficient data confirming its safety and effectiveness in the treatment of children and adolescents under the age of 18 years.

With impaired renal function

In renal failure, the anticoagulant should be used with caution. In patients, the systemic exposure of the drug increases, which increases the risk of bleeding.

For mild to moderate disorders, dose adjustment is not required, only observation is necessary. In case of severe impairment of renal function, the dose of Enixum is reduced.

For violations of liver function

In liver failure, the anticoagulant should be used with caution.

Use in the elderly

In the absence of impaired renal function, correction of the dosage regimen is not required in elderly patients, with the exception of treatment of myocardial infarction with ST segment elevation.

Initial IV bolus administration of the drug is contraindicated in patients with ST-segment elevation myocardial infarction. Enixum is prescribed n / a in a reduced dose.

During the use of enoxaparin in prophylactic doses, no tendency to an increase in bleeding was revealed. But with the use of therapeutic doses, there is such a risk, and therefore, careful medical supervision is necessary.

Drug interactions

Enixum must not be mixed with other drugs in the same syringe.

The risk of bleeding increases with the simultaneous use of other drugs that have an effect on hemostasis: acetylsalicylic acid and other salicylates, ketorolac and other non-steroidal anti-inflammatory drugs, dextran (whose molecular weight is 40 kDa), systemic glucocorticosteroids, clopidogrel, ticlopidine, other anti-coagulants agents, including antagonists of glycoprotein receptors IIb / IIIa.

Analogs

Eniksum analogs are Anfibra, Clexan, Flenox Neo, Gemapaksan, Fluxum, Cybor 2500, Cybor 3500, Fraxiparin, Fraxiparin Forte, Fragmin, etc.

Terms and conditions of storage

Keep out of the reach of children. Storage temperature should not exceed 25 ° C. Do not allow the solution to freeze.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Eniksum

Most often, the drug is used for preventive purposes - to prevent the development of venous thromboembolism after surgery, which is a serious complication. However, the use of enoxaparin is not limited to this indication. According to reviews, Enixum was prescribed for miscarriage, after gynecological operations, during hemodialysis, after myocardial infarction. In all cases, successful application was noted - no heavy bleeding occurred.

Many patients consider the disadvantages of Enixum to be painful injections and the relatively high cost of the drug.

The price of Enixum in pharmacies

Approximate prices for Enixum, depending on the pharmacy network, are (for 10 syringes in a package): 0.2 ml - 1580-1771 rubles, 0.3 ml - 2332 rubles, 0.5 ml - 2400 rubles, 0.6 ml - 3000 rubles, 0.7 ml - 4150-4310 rubles, 0.8 ml - 4500 rubles.

Enixum: prices in online pharmacies

Drug name Price Pharmacy

Enixum 10000 anti-Ha IU / ml solution for injection 0.6 ml 10 pcs. 2982 RUB Buy

Enixum 10000 anti-Ha IU / ml solution for injection 0.7 ml 10 pcs. 4154 RUB Buy

Enixum 10000 anti-Ha IU / ml solution for injection 0.8 ml 10 pcs. RUB 4579 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!