Fondaparinux Sodium

Indications

Prophylaxis Of Deep Vein Thrombosis- Fondaparinux is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):

  • In patients undergoing hip fracture surgery, including extended prophylaxis;
  • In patients undergoing hip replacement surgery;
  • In patients undergoing knee replacement surgery;
  • In patients undergoing abdominal surgery who are at risk for thromboembolic complications.

Treatment Of Acute Deep Vein Thrombosis: Fondaparinux is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.

Treatment Of Acute Pulmonary Embolism: Fondaparinux is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

Pharmacology

Fondaparinux, a synthetic pentasaccharide, acts as a selective inhibitor of activated factor X. It works by binding selectively to antithrombin III and potentiates the neutralisation of factor Xa. This will interrupt the blood coagulation cascade and inhibit both thrombin formation and thrombus development.

Dosage And Administration

Superficial vein thrombosis: 2.5 mg once daily for 30-45 days.

Venous thromboembolism: 

  • 50-100 kg: 7.5 mg once daily;
  • >100 kg: 10 mg once daily.
  • Treatment duration: 5-9 days, or until oral anticoagulation is established.

Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery: 2.5 mg once daily, starting 6-8 hr after surgery, continue for at least 5-9 days. In high-risk patients, 6-14 days or up to 32 days in hip fracture.

Interaction

Increased risk of bleeding with (e.g. desirudin, fibrinolytic drugs, glycoprotein IIb/IIIa-receptor antagonists, heparin, heparinoids or LMWH).

Contraindications

Hypersensitivity. Active clinically significant bleeding, acute bacterial endocarditis.

Side Effects

Hip-fracture, hip-replacement, or knee-replacement surgery: Anaemia, fever, nausea, oedema, constipation, rash, vomiting, insomnia, increased wound drainage, hypokalaemia, UTI, dizziness, purpura, hypotension, confusion, bullous eruption, urinary retention, haematoma, major bleeding, diarrhoea, dyspepsia, post-op haemorrhage, and headache. Treatment of venous thromboembolism: Constipation, headache, insomnia, fever, nausea, UTI, and coughing. Abdominal surgery: Post-op wound infection and haemorrhage, fever, surgical site reaction, anaemia, HTN, pneumonia, vomiting.

Pregnancy And Lactation

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Lactation: Unknown whether drug is excreted in milk; use with caution

Precautions And Warnings

Patient with increased risk of haemorrhage (e.g. congenital or acquired bleeding disorders, history or active Gl ulceration, intracranial haemorrhage, recent brain, spinal or ophth surgery)

Therapeutic Class

Parenteral anti-coagulants

Storage Conditions

Store below 25° C. Do not freeze.