Fondaparinux Sodium is a Factor Xa inhibitor (anticoagulant) indicated for:

Prophylaxis of deep vein thrombosis (DVT) in patients undergoing:

• Hip fracture surgery (including extended prophylaxis)
• Hip replacement surgery
• Knee replacement surgery
• Abdominal surgery

Treatment of DVT and acute pulmonary embolism (PE): When used in combination with warfarin.

Fondaparinux Sodium exerts its antithrombotic effect through selective inhibition of Factor Xa. By binding specifically to antithrombin III (ATIII), it enhances (approximately 300-fold) the natural inactivation of Factor Xa. This inhibition interrupts the coagulation cascade, thereby preventing thrombin generation and clot formation. Fondaparinux Sodium does not directly inhibit thrombin (Factor IIa) and has no effect on platelet function. At recommended doses, it does not influence fibrinolysis or bleeding time.

Prophylaxis of deep vein thrombosis:

• Fondaparinux 2.5 mg is administered subcutaneously once daily after hemostasis is achieved
• The first dose should be given no earlier than 6–8 hours after surgery and continued for 5–9 days
• In patients undergoing hip fracture surgery, extended prophylaxis for up to 24 additional days is recommended

Treatment of deep vein thrombosis and pulmonary embolism:

• Fondaparinux 5 mg (body weight <50 kg)
• Fondaparinux 7.5 mg (body weight 50–100 kg)
• Fondaparinux 10 mg (body weight >100 kg), administered subcutaneously once daily

Treatment should be continued for at least 5 days and until INR 2–3 is achieved with warfarin sodium.

Pediatric Use: The safety and effectiveness of Fondaparinux Sodium in pediatric patients have not been established.

Geriatric Use: In clinical studies, efficacy in patients aged 65 years or older was similar to that of younger patients, although serious adverse events increased with age.

Use in renal or hepatic impairment: The risk of bleeding is increased in patients with impaired renal or hepatic function.

Medications that may increase the risk of bleeding should be stopped before starting Fondaparinux Sodium therapy, unless they are absolutely essential. If co-administration is necessary, patients should be closely monitored for signs of bleeding (hemorrhage).

Fondaparinux Sodium is contraindicated in the following conditions:

• Severe renal impairment (creatinine clearance <30 mL/min)
• Active major bleeding
• Bacterial endocarditis
• Thrombocytopenia
• Body weight <50 kg (for venous thromboembolism prophylaxis only)
• History of severe hypersensitivity to Fondaparinux Sodium

The most common adverse effects of Fondaparinux Sodium include bleeding complications and mild local reactions such as injection site bleeding, rash, and itching following subcutaneous administration. Other reported effects include anemia, insomnia, hypokalemia, dizziness, hypotension, confusion, bullous eruptions, hematoma, and postoperative hemorrhage.

Pregnancy Category B. It is not known whether Fondaparinux Sodium is excreted in human breast milk. Caution should be exercised when administering Fondaparinux Sodium to a nursing woman.

• Use with caution in patients who have underlying conditions or are taking medications that increase the risk of bleeding
• The risk of bleeding is higher in patients with renal impairment and in those with low body weight (<50 kg)
• Evaluate the potential risks and benefits before performing neuraxial procedures in patients receiving or planned for anticoagulant therapy
• Thrombocytopenia may occur during treatment with Fondaparinux Sodium
• Regular monitoring of complete blood count (including platelet count), serum creatinine, and stool occult blood is recommended

Parenteral anticoagulants

Store below 25°C. Do not freeze. Keep out of the reach of children.