Enixum, 6000 anti-ha me/0.6 mL 0.6 mL 10 pcs

.

Indications

– Prevention of venous thrombosis and embolism in surgical interventions in moderate- and high-risk patients, especially in orthopedic and general surgical interventions, including cancer.

– Prevention of venous thrombosis and embolism in bedridden patients due to acute therapeutic conditions, including acute heart failure and decompensation of chronic heart failure (NYHA class III or IV), respiratory failure, and in severe infections and rheumatic diseases at increased risk of venous thrombosis (see section “Special Instructions”).

– Treatment of deep vein thrombosis with or without pulmonary embolism, except in cases of pulmonary embolism requiring thrombolytic therapy or surgery.

– Prevention of thrombosis in the extracorporeal circulation system during hemodialysis.

– Acute coronary syndrome:

Active ingredient

Composition

How to take, the dosage

Subcutaneously, except in special cases.

Prevention of venous thrombosis and embolism in surgical procedures in moderate to high risk patients

Patients at moderate risk of thrombosis and embolism (e.g., abdominal surgery) have a recommended dose of Enixum® 20 mg once daily subcutaneously. The first injection should be given 2 hours before the surgical intervention.

. In patients at high risk of thrombosis and embolism (e.g., orthopedic surgery, oncologic surgery, patients with additional non-surgical risk factors such as congenital or acquired thrombophilia malignant neoplasm, bed rest for more than three days, obesity, venous thrombosis in anamnesis, varicose veins of lower limbs, pregnancy) the drug is recommended in a dose of 40 mg once a day subcutaneously, with the first dose administered 12 hours before the surgical intervention. If earlier preoperative prophylaxis is necessary (e.g., in patients at high risk of thrombosis and thromboembolism awaiting delayed orthopedic surgery) the last injection should be given 12 hours before surgery and 12 hours after surgery.

The duration of treatment with Enixum is 7-10 days on average. If necessary, therapy may be continued as long as the risk of thrombosis and embolism persists and until the patient is switched to an outpatient regimen.

In major orthopedic surgeries, it may be appropriate to continue treatment after initial therapy with Enixum® at a dose of 40 mg once daily for five weeks.

In patients at high risk of venous thromboembolism who have undergone surgery, abdominal and pelvic surgery because of cancer, it may be advisable to increase the duration of Enixum® administration in a dose of 40 mg once daily for four weeks.

Prevention of venous thrombosis and embolism in patients on bed rest due to acute medical conditions

The recommended dose of Enixum® is 40 mg once daily, subcutaneously, for 6-14 days. The therapy should be continued until the patient is fully ambulatory (maximum 14 days).

The treatment of deep vein thrombosis with or without pulmonary embolism

The drug is administered subcutaneously at a rate of 1.5 mg/kg body weight once daily or 1 mg/kg body weight twice daily. The dosing regimen should be chosen by a physician on the basis of assessing the risk of thromboembolism and the risk of bleeding.

In patients without thromboembolic complications and at low risk of venous thromboembolism, the drug is recommended to be given subcutaneously at a rate of 1.5 mg/kg body weight once daily.

In all other patients, including patients with obesity, symptomatic pulmonary embolism, cancer, recurrent venous thromboembolism and proximal thrombosis (in the iliac vein), the drug is recommended at a dose of 1 mg/kg twice daily.

The duration of treatment is on average 10 days. It is recommended to start immediately the therapy with indirect anticoagulants and continue Enixum® therapy until therapeutic anticoagulant effect is achieved (INR value [International Normalized Ratio] should be 2.0-3.0).

Prevention of thrombosis in extracorporeal circulation during hemodialysis

The recommended dose of Enixum® is on average 1 mg/kg body weight. If the risk of bleeding is high, the dose should be reduced to 0.5 mg/kg body weight for dual vascular access or 0.75 mg/kg for single vascular access.

Treatment of unstable angina and myocardial infarction without ST-segment elevation

Enixum® is administered at a rate of 1 mg/kg body weight every 12 hours, subcutaneously, with concomitant use of antiplatelet therapy. Average therapy duration is at least 2 days and lasts until patient’s clinical condition stabilizes. The drug usually lasts from 2 to 8 days.

Acetylsalicylic acid is recommended for all patients with no contraindications, with an initial dose of 150-300 mg orally followed by a maintenance dose of 75-325 mg once daily.

The treatment of acute ST-segment elevation myocardial infarction, drug or percutaneous coronary intervention

The treatment begins with a single intravenous bolus injection of Enoxaparin sodium at a dose of 30 mg. Immediately thereafter, enoxaparin sodium is administered subcutaneously in a dose of 1 mg/kg of body weight. The drug is then administered subcutaneously at 1 mg/kg of body weight every 12 hours (maximum 100 mg of sodium enoxaparin for each of the first two subcutaneous injections, then 1 mg/kg of body weight for the remaining subcutaneous doses, that is, if the body weight exceeds 100 kg, the single dose may not exceed 100 mg).

As soon as possible after detection of acute myocardial infarction with ST-segment elevation, patients should be simultaneously prescribed acetylsalicylic acid and, if there are no contraindications, administration of acetylsalicylic acid (in doses of 75-325 mg) should be continued daily for at least 30 days.

The recommended duration of treatment with Enixum® is 8 days or until discharge from hospital (if hospitalization is less than 8 days).

In patients 75 years of age and older, initial intravenous bolus administration is not used. The drug is administered subcutaneously at a dose of 0.75 mg/kg every 12 hours (maximum 75 mg of enoxaparin sodium for each of the first two subcutaneous injections, then 0.75 mg/kg body weight for the remaining subcutaneous doses, that is, if the body weight exceeds 100 kg, the single dose cannot exceed 75 mg).

In patients undergoing percutaneous coronary intervention, if the last subcutaneous injection of enoxaparin sodium was given less than 8 hours before the balloon catheter inserted into the coronary artery constriction was inflated, no additional injection of enoxaparin sodium is required. If the last subcutaneous injection of sodium enoxaparin was given more than 8 hours before the balloon catheter was inflated, an additional intravenous bolus injection of sodium enoxaparin at a dose of 0.3 mg/kg should be given.

Interaction

Enoxaparin sodium must not be mixed with other medications!

Unrecommended combinations

Combinations requiring caution

– Other drugs affecting hemostasis, such as:

– Drugs that increase potassium content

Clinical and laboratory monitoring should be performed when concomitant use with drugs that increase serum potassium content.

Special Instructions

General

Low molecular weight heparins are not interchangeable, since they differ in manufacturing process, molecular weight, specific anti-Xa activity, dosing units and dosing regimen, with associated differences in their pharmacokinetics and biological activity (antithrombin activity and interaction with platelets). Therefore, it is necessary to strictly follow the recommendations for the use of each drug belonging to the class of low molecular weight heparins.

Bleeding

As with other anticoagulants, the administration of enoxaparin sodium may cause bleeding of any localization. If bleeding develops, the source of bleeding must be found and appropriate treatment administered.

Sodium enoxaparin, like other anticoagulants, should be used with caution in conditions with an increased risk of bleeding, such as:

Contraindications

– Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins.

. – Active clinically significant bleeding, as well as conditions and diseases with a high risk of bleeding, including recent hemorrhagic stroke, acute gastrointestinal (GI) ulcer, presence of malignant neoplasm with high risk of bleeding, Recent brain and spinal cord surgery, ophthalmologic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, vascular anomalies of the spinal cord and brain.

– Immune-mediated heparin-induced thrombocytopenia (history) within the past 100 days or the presence of circulating antiplatelet antibodies in the blood.

– Childhood under 18 years of age because efficacy and safety have not been established in this patient population.

Conditions in which there is a potential risk of bleeding:

– hemostasis disorders (including hemophilia, thrombocytopenia, hypocoagulation, Willebrand’s disease, etc.

– gastric or duodenal ulcer or other erosive ulcerative lesions of the gastrointestinal tract in the anamnesis;

– recent ischemic stroke;

– uncontrolled severe arterial hypertension;

– diabetic or hemorrhagic retinopathy;

– severe diabetes mellitus;

– recent or suspected neurologic or ophthalmic surgery;

– performing spinal or epidural anesthesia (potential risk of hematoma), spinal tap (recent);

– recent childbirth;

– bacterial endocarditis (acute or subacute);

– pericarditis or pericardial effusion;

– renal and/or hepatic insufficiency;

– intrauterine contraception (IUI);

– severe trauma (especially of the central nervous system), open wounds on large surfaces;

– concomitant administration of drugs affecting the hemostasis system;

– heparin-induced thrombocytopenia without a history of circulating antibodies (more than 100 days).

There are no data on the clinical use of enoxaparin sodium in the following diseases: active tuberculosis, radiation therapy (recent).

Side effects

The side effects of enoxaparin sodium have been studied in more than 15,000 patients who participated in clinical trials, including 1,776 patients in the prevention of venous thrombosis and embolism in general surgery and orthopedic surgery; 1,169 patients in the prevention of venous thrombosis and embolism in bed-ridden patients due to acute therapeutic conditions; in 559 patients, in the treatment of deep vein thrombosis with or without pulmonary embolism; in 1578 patients, in the treatment of unstable angina and myocardial infarction without a Q wave; in 10176 patients, in the treatment of ST-segment elevation myocardial infarction.

The mode of administration of enoxaparin sodium differed depending on the indication. In the prevention of venous thrombosis and embolism in general surgery and orthopedic surgery or in patients on bed rest, 40 mg was administered subcutaneously once daily.

In the treatment of unstable angina and myocardial infarction without Q-wave, the dose of enoxaparin sodium was 1 mg/kg body weight subcutaneously every 12 hours, and in case of myocardial infarction with ST-segment elevation, an intravenous bolus of 30 mg followed by 1 mg/kg body weight subcutaneously every 12 hours was administered.

The incidence of adverse reactions was determined in accordance with the classification of the World Health Organization: Very common (≥ 1/10); common (≥ 1/100 and < 1/10); infrequent (≥ 1/1000 and < 1/100); rare (≥ 1/10000 and < 1/1000); very rare (< 1/10000), frequency unknown (cannot be calculated from available data).

Vascular disorders

Bleeding

In clinical trials, bleeding was the most common adverse reaction. These included major bleeding, observed in 4.2% of patients (bleeding was considered major if it was accompanied by a decrease in hemoglobin of 2 g/L or more, required a transfusion of 2 or more doses of blood components, or if it was retroperitoneal or intracranial). Some of these cases were fatal.

As with other anticoagulants, bleeding is possible with the use of enoxaparin sodium, especially in the presence of risk factors that contribute to bleeding, during invasive procedures or when using drugs that disrupt hemostasis.

In the description of bleeding below, the sign “*” means to indicate the following types of bleeding: hematoma, ecchymoses (except those developed at the injection site), wound hematomas, hematuria, nasal bleeding, gastrointestinal bleeding.

Very common: bleeding* during prophylaxis of venous thrombosis in surgical patients and treatment of deep vein thrombosis with or without pulmonary embolism.

Often: Bleeding* in prophylaxis of venous thrombosis in bed-ridden patients and in treatment of unstable angina pectoris, myocardial infarction without Q wave and ST-segment elevation myocardial infarction.

Infrequent: retroperitoneal bleeding and intracranial hemorrhage in patients treated for deep vein thrombosis with or without pulmonary embolism and for treatment of ST-segment elevation myocardial infarction.

Rarely: retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients and in the treatment of unstable angina and myocardial infarction without Q-wave.

Thrombocytopenia and thrombocytosis

Very common: Thrombocytosis (peripheral blood platelet count greater than 400×109/L) in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without pulmonary embolism.

Often: Thrombocytosis in the treatment of patients with acute ST-segment elevation myocardial infarction.

Thrombocytopenia in prevention of venous thrombosis in surgical patients and treatment of deep vein thrombosis with or without pulmonary embolism and in acute ST-segment elevation myocardial infarction.

Infrequent: thrombocytopenia in prophylaxis of venous thrombosis in patients on bed rest and in treatment of unstable angina and myocardial infarction without Q-wave.

Very rare: autoimmune thrombocytopenia in the treatment of patients with acute ST-segment elevation myocardial infarction.

Other clinically significant adverse reactions, regardless of indication

The adverse reactions presented below are grouped by systemic organ class, given by the frequency of occurrence defined above and in decreasing order of severity.

Disorders of the blood and lymphatic system:

often: bleeding, thrombocytopenia, thrombocytosis;

rarely: cases of autoimmune thrombocytopenia with thrombosis; in some cases, thrombosis was complicated by the development of organ infarction or limb ischemia.

Disorders of the immune system:

often: allergic reactions.

Liver and biliary tract disorders:

very common: increased activity of “liver” enzymes, mainly increased activity of transaminases, more than three times the upper limit of normal.

Skin and subcutaneous tissue disorders:

often: urticaria, skin itching, erythema.

infrequent: bullous dermatitis.

General disorders and disorders at the injection site:

often: injection site hematoma, injection site pain, injection site swelling, bleeding, hypersensitivity reactions, inflammation, formation of lumps at the injection site.

Infrequent: irritation at the injection site, necrosis of the skin at the injection site.

Data obtained after the drug was placed on the market

The following adverse reactions have been reported in the post-marketing use of enoxaparin sodium. There have been spontaneous reports of these adverse reactions.

Disorders of the immune system:

Rarely: anaphylactic/anaphylactoid reactions, including shock.

Nervous system disorders:

often: headache.

vascular disorders:

seldom: cases of spinal hematoma (or neuroaxial hematoma) have been reported when using enoxaparin sodium against the background of spinal/epidural anesthesia or spinal tap. These reactions led to the development of neurological disorders of varying severity, including persistent or irreversible paralysis.

Disorders of the blood or lymphatic system:

often: hemorrhagic anemia;

rarely: eosinophilia

Skin and subcutaneous tissue disorders:

rarely: alopecia; cutaneous vasculitis, skin necrosis may develop at the injection site, usually preceded by the appearance of purpura or erythematous papules (infiltrated and painful). In these cases, therapy with enoxaparin sodium should be discontinued.

The formation of solid inflammatory nodules-infiltrates at the site of injection of the drug is possible, which disappear after a few days and are not a reason for discontinuation of the drug.

Hepatic and biliary tract disorders:

infrequent: hepatocellular liver damage;

rare: cholestatic liver damage.

Muscular and connective tissue disorders:

seldom: osteoporosis with prolonged therapy (more than three months).

Laboratory and instrumental findings:

rarely: hyperkalemia.

Overdose

An accidental overdose of enoxaparin sodium with intravenous, extracorporeal or subcutaneous administration may lead to hemorrhagic complications. Absorption is unlikely when administered orally, even in large doses.

Similarities