Clexane is a drug with antithrombotic action.
Release form and composition
Clexane is produced in the form of a solution for injections - transparent, from pale yellow to colorless (in disposable syringes, 2 syringes in blisters, 1 or 5 blisters in carton packs).
The composition of 1 syringe includes:
- Active ingredient: Enoxaparin sodium - 2000/4000/6000/8000/10000 anti-Ha IU;
- Solvent: water for injection - up to 0.2 / 0.4 / 0.6 / 0.8 / 1 ml.
Indications for use
Clexane is prescribed for the treatment of pathologies:
- Deep vein thrombosis with or without pulmonary embolism;
- Unstable angina and myocardial infarction without a Q wave simultaneously with acetylsalicylic acid;
- Acute myocardial infarction with ST-segment elevation in patients to be followed by percutaneous coronary intervention or drug treatment.
Also, the drug is prescribed for prophylactic purposes:
- Venous thrombosis and embolism during surgical interventions, especially during operations (general surgical and orthopedic);
- Thrombus formation during hemodialysis in the extracorporeal circulation (usually with a session up to 4 hours);
- Embolism and venous thrombosis in patients on bed rest due to acute therapeutic diseases, for example, acute respiratory failure, decompensation of chronic heart failure and acute heart failure (NYHA class III or IV), as well as acute rheumatic diseases and severe acute infections in combination with one of the risk factors for venous thrombosis.
- Diseases and conditions in which there is an increased risk of bleeding: hemorrhagic stroke, threatening abortion, dissecting aortic aneurysm or aneurysm of cerebral vessels (other than surgery), severe enoxaparin- and heparin-induced thrombocytopenia, uncontrolled bleeding;
- Age up to 18 years (safety and efficacy for this age group have not been established);
- Hypersensitivity to the active substance, as well as to heparin or its derivatives, including other low molecular weight heparins.
Clexane is not recommended for use by pregnant women with an artificial heart valve.
To take the drug during pregnancy is necessary only in cases where a doctor has established an urgent need for therapy. At the time of taking Clexane need to stop breastfeeding.
The drug is used with caution in diseases / conditions:
- Severe vasculitis, impaired hemostasis (including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand disease, etc.);
- Severe diabetes;
- Peptic ulcer or duodenal ulcer or other lesions of the gastrointestinal tract of erosive and ulcerative nature;
- Severe uncontrolled arterial hypertension;
- Pericardial effusion or pericarditis;
- Bacterial endocarditis (acute or subacute);
- Recently suffered ischemic stroke;
- Retinopathy (hemorrhagic or diabetic);
- Ophthalmologic or neurologic surgery (presumptive or recent);
- Recent childbirth;
- Epidural or spinal anesthesia (risk of hematoma), recent spinal puncture;
- Intrauterine contraception;
- Renal and / or liver failure;
- Open wounds of a large area;
- Simultaneous use with drugs that affect the hemostatic system;
- Severe injuries (especially the central nervous system).
There are no data on the clinical use of Clexan in active tuberculosis and recently transferred radiation therapy.
Dosing and Administration
Except in special cases, Clexane is injected subcutaneously deep (the drug cannot be administered intramuscularly). It is desirable to introduce the solution in the position of the patient lying down.
Injections should be carried out alternately in the left or right posterior lateral or anterolateral regions of the abdominal wall. The needle should be inserted at full length into the skin fold vertically, gathering and holding it with the index and thumb. Release the skin fold only after the end of the injection. Massage the introduction of Clexane should not be.
In the prevention of embolism and venous thrombosis during surgical interventions, especially in general surgical and orthopedic operations, it is usually prescribed:
- The moderate risk of developing embolism and thrombosis (general surgery) is 1 time a day for 20 mg. The first injection is made 2 hours before surgery;
- High risk of embolism and thrombosis (orthopedic and general surgery) - 1 time a day, 40 mg (the first dose should be administered 12 hours before the operation) or 2 times a day 30 mg (the drug is administered 12-24 hours after the operation ).
The duration of therapy is usually 7-10 days. If necessary, treatment is continued for longer, as long as there is a risk of developing embolism and thrombosis (for example, Clexane in orthopedics is prescribed once a day, 40 mg for 5 weeks).
In the prevention of embolism and venous thrombosis in patients on bed rest due to acute therapeutic diseases, Clexane is used for 6-14 days 1 time per day, 40 mg.
When treating deep vein thrombosis with or without pulmonary thromboembolism, Clexane should be administered at the rate of 1.5 mg / kg 1 time per day or 2 times per day at 1 mg / kg. In patients with complicated thromboembolic disorders, Clexane is recommended to be administered 2 times a day at 1 mg / kg. The duration of therapy is on average 10 days. It is recommended to immediately begin treatment with oral anticoagulants, while the use of Clexane should be continued until the desired anticoagulant effect is achieved.
With the prevention of thrombosis during hemodialysis in the extracorporeal circulation, the average dose of Clexane is 1 mg / kg. If there is a high risk of bleeding, reduce the dose:
- Unary vascular access - up to 0.75 mg / kg;
- Dual vascular access - up to 0.5 mg / kg.
In hemodialysis, Clexane should be administered at the beginning of a hemodialysis session in the arterial shunt area. As a rule, 1 dose of the drug is sufficient for a four-hour session, however, with fibrin rings with a longer hemodialysis, it is possible to additionally introduce a solution at the rate of 0.5-1 mg / kg. When treating myocardial infarction without Q wave and unstable angina, Clexane should be administered every 12 hours at the rate of 1 mg / kg simultaneously with acetylsalicylic acid, 100-325 mg once a day. The average duration of treatment is 2-8 days (until the stabilization of the clinical condition).
Treatment of myocardial infarction with ST-segment elevation (medication or using percutaneous coronary intervention) is started from a bolus administration (intravenously) of Clexan at a dose of 30 mg, after which, within 15 minutes, 1 mg / kg of the solution is injected subcutaneously (maximum for the first two subcutaneous injections) dose is 100 mg of the drug). All subsequent doses are administered subcutaneously 2 times a day at equal intervals of 1 mg / kg body weight.
For patients over the age of 75, the initial intravenous bolus administration does not apply. Clexane is administered subcutaneously. A single dose - 0.75 mg / kg, the frequency of use - every 12 hours (during the first two subcutaneous injections, you can enter 75 mg of the drug as much as possible). All subsequent doses are administered subcutaneously 2 times a day (every 12 hours) in the same dose.
When combined with thrombolytic agents (fibrin-specific and fibrin-specific), Clexane must be administered in the range from 15 minutes before the start of thrombolytic therapy to 30 minutes after it. As soon as possible after detecting acute myocardial infarction with ST segment elevation, it is necessary to simultaneously begin taking acetylsalicylic acid and, in the absence of contraindications, continue therapy for at least 30 days, 75-325 mg daily.
The recommended duration of drug treatment is 8 days or until the patient is released from the hospital (if the period of hospitalization is less than 8 days).
The bolus administration of Clexane is carried out through a venous catheter; the drug should not be mixed or administered together with other drugs. Before and after intravenous bolus administration of Clexane, the venous catheter should be washed with 0.9% sodium chloride or dextrose solution. This will help to avoid the presence of traces of other drugs in the system and, therefore, their interaction. The drug can be safely administered with solutions of 5% dextrose and 0.9% sodium chloride.
For bolus administration of 30 mg of Clexane in the treatment of acute myocardial infarction with ST segment elevation from glass syringes by 60 mg, 80 mg and 100 mg, an excessive amount of the drug should be removed.
For patients undergoing percutaneous coronary intervention, if the last subcutaneous injection of Clexane was performed less than 8 hours prior to inflation of the balloon catheter introduced at the site of the narrowing of the coronary artery, no additional solution is required. If the last subcutaneous injection of Clexane was performed more than 8 hours before the ballooning of the balloon catheter was inflated, 0.3 mg / kg of the drug must be injected intravenously.
Elderly patients in the absence of renal dysfunction, for all indications, except for the treatment of myocardial infarction with ST-segment elevation, a reduction in doses of Clexane is not required.
In severe impaired renal function, the dose of Clexane should be reduced. With mild and moderate renal impairment, dose adjustment should not be carried out, but in this case more careful laboratory monitoring of therapy is necessary.
Due to the lack of clinical studies, care must be taken when administering Clexane to patients with impaired liver function.
During therapy, it is possible that vascular disorders may develop in the form of bleeding, thrombocytosis and thrombocytopenia.
Also, regardless of the indications during treatment may develop other clinically significant adverse reactions:
- Immune system: often - allergic reactions; rarely, anaphylactoid and anaphylactic reactions;
- Subcutaneous tissue and skin: often - itching, erythema, urticaria; infrequently - bullous dermatitis;
- Biliary tract and liver: very often - increased activity of liver enzymes;
- Instrumental and laboratory data: rarely - hyperkalemia;
- Disturbances at the injection site and general disorders: often - hematoma, pain, swelling, lumpiness and inflammation at the injection site, bleeding, hypersensitivity reactions; infrequently - irritation and necrosis of the skin at the injection site.
During post-marketing use of Clexane, the development of the following adverse reactions with an unknown frequency was also noted:
- Biliary tract and liver: cholestatic damage to the liver, hepatocellular damage to the liver;
- Immune system: anaphylactoid / anaphylactic reactions, including shock;
- Vessels: spinal or neuroaxial hematoma (when using the drug against a background of spinal / epidural anesthesia);
- Nervous system: headache;
- Skin and subcutaneous tissues: alopecia, at the injection site - skin necrosis, dermal vasculitis, solid inflammatory nodules-infiltrates (disappear after a few days and are not grounds for discontinuation of the drug);
- Blood or lymphatic system: hemorrhagic anemia, immune-allergic thrombocytopenia with thrombosis, eosinophilia;
- Connective and musculoskeletal tissue: osteoporosis (with therapy longer than 3 months).
Low molecular weight heparins are not interchangeable because they differ in biological activity and pharmacokinetics (interaction with platelets and antithrombin activity). In this regard, it is necessary to strictly adhere to the recommendations for use for each drug belonging to the class of low molecular weight heparins.
With the development of bleeding during therapy should find its source and conduct appropriate treatment. It is recommended to carefully monitor the condition of patients older than 80 years, because there is an increased risk of bleeding.
An increase in Clexan's anti-Xa activity with its prophylactic use in women weighing up to 45 kg and in men weighing less than 57 kg may lead to an increased risk of bleeding.
In patients with obesity, there is an increased risk of thrombosis and embolism. The efficacy and safety of the drug in prophylactic doses in these patients is not fully defined, and there is no consensus on dose adjustment. In this regard, patients with obesity need to be monitored for signs of emboli and thrombosis.
Prior to use Clexane recommended discontinue therapy agents capable disrupt hemostasis (salicylates including acetylsalicylic acid, nonsteroidal antiinflammatory drugs, ticlopidine, dextran with a molecular weight of 40 kDa, antiplatelet agents, clopidogrel, steroids, anticoagulants, thrombolytics, except where their use is strictly shown.
In patients with renal impairment, there is a risk of bleeding due to an increase in Clexan's systemic exposure.
Thrombocytopenia usually develops from 5 to 21 days after the start of Clexan. In this regard, before the start of therapy and during the use of the drug is recommended to regularly monitor the number of platelets in the peripheral blood. With a confirmed significant reduction in the number of platelets (30-50% compared with baseline), the drug should be immediately canceled and the treatment regimen changed.
The risk of neuroaxial hematomas in the application of Clexane simultaneously with the conduct of epidural / spinal anesthesia decreases with the introduction of the drug in a dose of up to 40 mg.
Clexane should be used with caution in patients with a history of heparin-induced thrombocytopenia with or without thrombosis.
With the development of acute infections and acute rheumatic conditions, prophylactic use of Clexane is only justified when combined with the following risk factors for venous thrombosis:
- Malignant neoplasms;
- Age over 75 years;
- Embolism and thrombosis in history;
- Heart failure;
- Hormonal therapy;
- Chronic respiratory failure.
Mixed with other drugs Clexan can not.
It is not recommended to alternate Clexane with other low molecular weight heparins, since they differ from each other in molecular weight, mode of production, specific anti-Xa activity, dosage and units of measurement.
While the use of acetylsalicylic acid, nonsteroidal antiinflammatory drugs (including ketorolac), salicylates systemic action, dextran with a molecular weight of 40 kDa, clopidogrel and ticlopidine, systemic corticosteroids, anticoagulants or thrombolytic agents, other antiplatelet drugs increases the risk of bleeding.
Terms and conditions of storage
Store at temperatures up to 25 ° C out of the reach of children.
Shelf life - 3 years.