Instructions for use CLEXANE

Clexane is just one of many drugs that are used in medicine, including obstetrics, gynecology and reproductive medicine to thin the blood. For example, fraxiparin, fragmin and others have the same effect. All of these are low molecular weight heparins. Their feature is resistance to the formation of blood clots, thanks to which it is possible to save the lives of many people (including those with today’s dangerous viral infection), as well as preserve pregnancy and help avoid complications during hormonal therapy.

Blood clotting disorders underlie many pathological processes. I will not describe in detail the entire complex mechanism of blood clot formation, I will only say that this is the most common cause of early pregnancy loss. The sources of such complications can be both severe gestosis and the most dangerous condition - disseminated intravascular coagulation syndrome, i.e. a condition when, due to the massive formation of blood clots, the blood coagulation system “breaks” and can no longer work, after which bleeding is almost impossible to stop.

Adequate and timely use of anticoagulants can save you from all these problems.

When we use them

  1. After transfer against the background of ovulation stimulation to prevent ovarian hyperstimulation syndrome (if there is a risk of developing such a complication, and for some reason the transfer could not be postponed);
  2. In the case of preparing the endometrium for pregnancy while using hormone replacement therapy with large dosages of estrogens (they have a rather dangerous side effect - the risk of blood clots);
  3. In cases of recurrent miscarriage (loss of 2 pregnancies), especially if examination in the blood reveals antibodies to phospholipids, lupus anticoagulant, elevated levels of d-Dimer, Leiden mutation and other factors predisposing to impaired hemostasis.
  4. During pregnancy, the level of d-dimer, hemostasiogram and other factors are necessarily monitored, on the basis of which a decision is made to continue taking heparin drugs (sometimes they have to be taken until birth).

Instructions for use CLEXANE

Since clinical studies have not been conducted in patients with impaired liver function, special caution is required when using Clexane in this category of patients.

When prescribing the drug for prophylactic purposes, there was no tendency to increase bleeding. When prescribing the drug for therapeutic purposes, there is a risk of bleeding in older patients (especially those over 80 years of age). Close monitoring of the patient's condition is recommended.

Before starting therapy with this drug, it is recommended to discontinue other drugs that affect the hemostatic system due to the risk of bleeding:

  • salicylates, incl. acetylsalicylic acid, NSAIDs (including ketorolac);
  • dextran 40, ticlopidine, clopidogrel, corticosteroids, thrombolytics, anticoagulants, antiplatelet agents (including antagonists of glycoprotein IIb/IIIa receptors), except in cases where their use is necessary. If it is necessary to use Clexane in combination with these drugs, special caution must be observed (careful monitoring of the patient’s condition and relevant laboratory blood parameters).

In patients with impaired renal function, there is a risk of bleeding as a result of increased anti-Xa activity. Because this increase increases significantly in patients with severe renal impairment (creatinine clearance <30 ml/min); dose adjustment is recommended for both prophylactic and therapeutic use of the drug. Although no dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min), close monitoring of such patients is recommended.

An increase in the anti-Xa activity of enoxaparin when administered prophylactically in women weighing less than 45 kg and in men weighing less than 57 kg may lead to an increased risk of bleeding.

The risk of immune thrombocytopenia caused by heparin also exists with the use of low molecular weight heparins. If thrombocytopenia develops, it is usually detected between 5 and 21 days after initiation of enoxaparin sodium therapy. In this regard, it is recommended to regularly monitor the platelet count before starting treatment with enoxaparin sodium and during its use. If there is a confirmed significant decrease in platelet count (by 30-50% compared to the initial value), it is necessary to immediately discontinue enoxaparin sodium and transfer the patient to another therapy.

Multi-use vials containing sodium metabisulfite as a preservative may cause allergic reactions including anaphylactic symptoms and bronchospasm in patients with hypersensitivity to sodium metabisulfite, especially those with a history of asthma or allergies.

Spinal/epidural anesthesia

As with the use of other anticoagulants, cases of spinal cord hematoma have been described when using Clexane during spinal/epidural anesthesia with the development of persistent or irreversible paralysis. The risk of these events is reduced when using the drug at a dose of 40 mg or lower. The risk increases with increasing dosage of the drug, as well as with the use of penetrating epidural catheters after surgery, or with the concomitant use of additional drugs that have the same effect on hemostasis as NSAIDs. The risk also increases with traumatic exposure or repeated spinal puncture.

To reduce the risk of bleeding from the spinal canal during epidural or spinal anesthesia, it is necessary to take into account the pharmacokinetic profile of the drug. It is best to install or remove a catheter when the anticoagulation effect of enoxaparin sodium is low.

Installation or removal of the catheter should be carried out 10-12 hours after the use of prophylactic doses of Clexane for deep vein thrombosis. In cases where patients receive higher doses of enoxaparin sodium (1 mg/kg 2 times/day or 1.5 mg/kg 1 time/day), these procedures should be postponed for a longer period of time (24 hours). Subsequent administration of the drug should be carried out no earlier than 2 hours after removal of the catheter.

If the physician prescribes anticoagulation therapy during epidural/spinal anesthesia, the patient should be closely monitored for any neurological signs and symptoms, such as:

  • back pain, sensory and motor dysfunction (numbness or weakness in the lower extremities), bowel and/or bladder dysfunction. The patient should be instructed to immediately inform the doctor if the above symptoms occur. If signs or symptoms consistent with a brainstem hematoma are detected, prompt diagnosis and treatment are necessary, including spinal decompression if necessary.

Heparin-induced thrombocytopenia

Clexane should be prescribed with extreme caution to patients with a history of heparin-induced thrombocytopenia, with or without thrombosis.

The risk of thrombocytopenia caused by heparin may persist for several years. If heparin-induced thrombocytopenia is suspected based on history, in vitro platelet aggregation tests are of limited value in predicting the risk of its development. The decision to prescribe Clexane in this case can only be made after consultation with an appropriate specialist.

Percutaneous coronary angioplasty

In order to reduce the risk of bleeding associated with invasive vascular manipulation in the treatment of unstable angina, the catheter should not be removed for 6-8 hours after subcutaneous administration of Clexane. The next calculated dose should be administered no earlier than 6-8 hours after removal of the catheter. The injection site should be monitored to promptly identify signs of bleeding and hematoma formation.

Artificial heart valves

No studies have been conducted to reliably assess the effectiveness and safety of Clexane in preventing thromboembolic complications in patients with artificial heart valves, therefore the use of the drug for this purpose is not recommended.

Laboratory tests

At doses used for the prevention of thromboembolic complications, Clexane does not significantly affect bleeding time and overall coagulation rates, as well as platelet aggregation or their binding to fibrinogen.

As the dose increases, the aPTT and clotting time may prolong. The increase in APTT and clotting time is not in direct linear relationship with the increase in the antithrombotic activity of the drug, so there is no need to monitor them.

Prevention of venous thrombosis and embolism in patients with acute therapeutic diseases who are on bed rest

In the event of the development of an acute infection or acute rheumatic conditions, prophylactic administration of enoxaparin sodium is justified only in the presence of risk factors for venous thrombus formation (age over 75 years, malignant neoplasms, history of thrombosis and embolism, obesity, hormonal therapy, heart failure, chronic respiratory failure).

Use in pediatrics

Due to the lack of clinical data on the safety and effectiveness of the drug in children and adolescents under 18 years of age

, the administration of Kleskan to this group of patients is contraindicated.

Impact on the ability to drive vehicles and operate machinery

Clexane does not affect the ability to drive vehicles and machines.

Experimental results

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of enoxaparin.

No mutagenic effect of enoxaparin was detected when tested in vitro, including the Ames test, the test for inducing mutations in mouse lymphoma cells and the test for inducing chromosomal aberrations in human lymphocytes, as well as in vivo in the test for inducing chromosomal aberrations in rat bone marrow cells.

With the exception of anticoagulant effects, no adverse reactions were observed with enoxaparin administered subcutaneously at a dose of 15 mg/kg/day during a 13-week toxicology study in rats and dogs and at a dose of 10 mg/kg/day during a 26-week study. weekly toxicological studies in rats and monkeys, to which the drug was administered subcutaneously or intravenously at a dose of 10 mg/kg/day.

Indications for use

This drug has the following indications:

  • prevention of thrombosis and embolism after surgery;
  • therapy for deep vein thrombosis , complicated or uncomplicated by pulmonary embolism ;
  • prevention of thrombosis and venous embolism in persons who are on bed rest for a long time due to acute therapeutic pathology (chronic and acute heart failure , severe infection , respiratory failure , acute rheumatic diseases );
  • prevention of thrombosis in the extracorporeal blood flow system during hemodialysis ;
  • therapy for angina and heart attack without a Q wave;
  • therapy of acute infarction with ST segment elevation in individuals requiring drug treatment.

Clexane price

It should be noted that the cost of this drug does not always correlate with the dosage. The average price of Clexane 0.2 ml (10 pcs.) in Russia is 3600 rubles, Clexane 0.4 ml (10 pcs.) - 2960 rubles, 0.8 ml (10 pcs.) - 4100 rubles, and buying the drug in the same dosages in Moscow will not cost much more expensive.

In Ukraine, the price of Clexane 0.2 ml No. 10 is 665 hryvnia, 0.4 ml No. 10 is 1045 hryvnia, and 0.8 ml No. 10 is 323 hryvnia.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine
  • Online pharmacies in KazakhstanKazakhstan

ZdravCity

  • Clexane solution d/in.
    4000 anti-Xa IU/0.4ml 9pcs JSC Pharmstandard-UfaVITA RUB 2,317 order

Pharmacy Dialogue

  • Clexane (solution d.in.4000 anti-HaME/0.4 ml 0.4 ml No. 9 syringes) FS-UfaVita

    RUB 2,479 order

  • Clexane injection solution 4000 anti-Xa IU/0.4 ml 0.4 ml syringes No. 9FS-UfaVita

    RUB 2,227 order

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Pharmacy24

  • Clexane 40 mg 0.4 ml N10 solution Sanofi Vinthrop Industries, France
    1256 UAH order
  • Clexane 300 Enoxaparin 3 ml injection solution FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Spain

    474 UAH. order

  • Clexane 20 mg 0.2 ml N10 solution Sanofi Vinthrop Industries, France

    786 UAH. order

  • Clexane 8000 anti-Xa IU/ 0.8 ml 80 mg No. 2 injection solution with needle protection mechanism Sanofi Winthrop Industries, France

    375 UAH. order

PaniPharmacy

  • Clexane syringe Clexane solution for injection 8000 anti-Ha ME syringe dose 0.8 ml No. 2 France, Aventis Intercontinental

    446 UAH. order

  • Clexane syringe Clexane solution for injection 2000 anti-Ha ME syringe dose 0.2 ml No. 10 France, Sanofi Winthrop Industrie

    781 UAH. order

  • Clexane syringe Clexane solution for injection 4000 anti-Ha ME syringe dose 0.4 ml No. 10 France, Aventis Pharma Specialite

    1265 UAH. order

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Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Clexane INN (international nonproprietary name) enoxaparin . The drug is a low molecular weight heparin with a molecular weight of about 4500 daltons. It is obtained by alkaline hydrolysis of heparin benzyl ether , extracted from the intestinal mucosa of pigs.

When used in prophylactic doses, the drug weakly changes the aPTT and has almost no effect on platelet aggregation and binding to fibrinogen. In therapeutic doses, enoxaparin increases APTT by 1.5-2.2 times.

Pharmacokinetics

After systematic subcutaneous injections of enoxaparin sodium 1.5 mg per kilogram of body weight once a day, the equilibrium concentration occurs after 2 days. Bioavailability when administered subcutaneously reaches 100%.

Enoxaparin sodium is metabolized in the liver through desulfation and depolymerization . The resulting metabolites have very low activity.

The half-life is 4 hours (single administration) or 7 hours (multiple administration). 40% of the drug is excreted through the kidneys. Elimination of enoxaparin in elderly patients is delayed as a result of deteriorating renal function.

In persons with kidney damage, the clearance of enoxaparin is reduced.

Clexane's analogs

Level 4 ATC code matches:
Angioflux

Hemapaxan

Fragmin

Wessel Due F

Fraxiparine

Analogues of Clexane with identical active ingredients: Clexane 300 , Novoparin , Enoxarin .

Which is better: Clexane or Fraxiparine?

A frequently asked question from patients about the comparative effectiveness of drugs. Fraxiparine and Clexane belong to the same group and are analogues. There have been no studies reliably confirming the superiority of one drug over another. Therefore, the choice between drugs should be made by the attending physician based on the clinical picture of the disease, the patient’s condition and his own experience.

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