Properties
What is it?
Clinical-pharmacological group - Antithrombotic and anticoagulant agents; direct-acting anticoagulants Composition and dosage form Solution for injection: in a pre-filled syringe 0.5 ml (2.5 mg.) 10 pcs. Solution for injection: in a disposable syringe 0.5 ml, in a package 10 pcs. 1 syringe Fondaparinux sodium...... 2.5 mg Excipients: Sodium chloride, hydrochloric acid, sodium hydroxide, water for injection Pharmacological properties Arixtra is a synthetic selective inhibitor of activated factor X (Xa), whose antithrombotic activity is associated with selective inhibition of blood coagulation factor Xa via antithrombin III. Based on selective binding to antithrombin III, fondaparinux sodium increases (approximately 300-fold) the inhibition of factor Xa by antithrombin III; blockade of factor Xa interrupts the coagulation cascade and inhibits both thrombin and clot formation. Fondaparinux sodium does not inactivate thrombin (activated factor IIa) and does not affect platelets. The use of Arixtra at a dose of 2.5 mg does not affect the results of general coagulation tests (activated partial thromboplastin time, clotting time, prothrombin time, bleeding time) and fibrinolytic activity. The pharmacodynamics and pharmacokinetics of fondaparinux are determined by the drug concentration in plasma, expressed as anti-Xa factor activity. The anti-Xa activity of fondaparinux is determined individually, and standard international standards for heparin and low molecular weight heparins are not applicable to it. Indications - Prevention of venous thromboembolic complications in the lower extremities after major orthopedic surgery (including hip fracture, including prolonged prophylaxis in the postoperative period, as well as during hip and knee replacement surgery); - Prevention of venous thromboembolic complications in patients at risk of thromboembolic complications after abdominal surgery; - Prevention of venous thromboembolic complications in medical patients at high risk of thromboembolic complications due to prolonged immobility after the acute phase of illness; - Treatment of acute deep vein thrombosis; - Treatment of acute pulmonary embolism; - Treatment of acute coronary syndrome, unstable angina, and non-ST-segment elevation myocardial infarction to prevent mortality, myocardial infarction, and refractory ischemia; - Treatment of ST-segment elevation myocardial infarction to prevent mortality and recurrent myocardial infarction in patients treated with thrombolytic agents or in patients who have not undergone primary reperfusion therapy. Dosage and administration Subcutaneous injection: The drug is administered alternately into the right and left anterolateral and posterolateral abdominal wall, subcutaneously. To avoid loss of the drug, it is not recommended to expel air bubbles from the pre-filled syringe before injection. The needle is inserted perpendicularly into the full depth of the skin fold, which is fixed between the thumb and index finger until the solution is completely injected. Intravenous injection: (Intravenously administered only for the first dose during the treatment of ST-segment elevation myocardial infarction) Administered directly into the intravenous line without dilution or diluted in a small volume (25 or 50 ml) of 0.9% saline. To avoid loss of the drug, it is not necessary to expel air bubbles from the pre-filled syringe before injection. After injection, the system and catheter should be thoroughly flushed with saline to ensure that the drug has been completely administered. When diluting Arixtra with saline, intravenous administration of the drug is recommended over 1-2 minutes.