Fondaparinux Sodium

Anticoagulant/Antiplatelet · Pentasaccharide that inhibits activated factor X

Indications

Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs (e.g. hip fracture, major knee surgery or hip replacement surgery).

Dosage

Adults: Hip Fracture or Replacement Surgery/ Knee Replacement Surgery/Abdominal Surgery: SC: 2.5 mg daily, starting 6-8 hr post-operation for 5-9 days (Hip/Knees: up to 11 day; Abdominal: up to 10 day). Hip Fracture Surgery: Extended prophylaxis up to 24 additional days. DVT/PE Treatment: SC: Body weight less than 50 kg: 5 mg daily. Body weight 50-100 kg: 7.5 mg daily. Body weight above 100 kg: 10 mg daily. Add concomitant warfarin ASAP (usually within 72 hr) and continue for 5-9 days (up to 26 days) until INR is = 2 for at least 24 hrs. Children: Not recommended.

Administration

Do not administer IM, only via SC inj. Do not mix with other inj or infusions. Early initiation (before 6 hours after surgery) has been associated with increased bleeding. Rotate injection sites using left and right anterolateral or left and right posterolateral abdominal wall. Do not expel air bubble from prefilled syringe before injection to prevent expelling drug from syringe. Compatibility: Do not mix with other injections or infusions. Stability: Store at 25°C (77°F); excursions permitted between 15°C-30°C (59°F-86°F).

Adverse Effects

Anaemia, bleeding (incl GI, gingival, utero-vaginal, ocular, haematuria, haematoma, epistaxis, haemoptysis, purpura, bruise), thrombocytopenia (uncommon), abnormal liver function tests, oedema.

Risk Factor (Pregnancy/Lactation)

Pregnancy: No evidence of risk in humans. Lactation: Caution advised or effect undetermined. Contraindications: Patients with active bleeding. Severe renal impairment. Acute bacterial endocarditis, heparin induced thrombocytopenia type II, Superficial vein thrombosis, severe hepatic impairment. Precautions: Haemorrhage. Renal or hepatic impairment, elderly, children below 17 years age. Heparin induced thrombocytopenia. Latex allergy. Risk of haemorrhage incl GI ulceration, recent brain, spinal or ophthalmic surgery. Spinal or epidural anaesthesia, spinal puncture.

Interactions

Fibrinolytic agents, desirudin, heparin, heparinoids, other antiplatelet drugs, NSAIDs, vit K antagonist.

Advice to Patient

If patient is self-administering this medication, exact directions for administration of injection and needle disposal must be followed. Do not rub the site after administering injection. Report pain, burning, redness or swelling at injection site or if there is unusual bleeding or bruising, dark stool, joint pain, back pain, unusual fever, confusion, other CNS changes, persistent nausea, GI discomfort or changes in urinary pattern. Use soft toothbrush, waxed dental floss, electric razor. Avoid scissors and sharp knives.

Pharmacokinetics

Absorption: SC: Rapid and complete. Bioavailability: SC: 100%. Half-life elimination: 17-21 hrs, prolonged with renal impairment and in the elderly. Time to peak: SC: Approx. 2-3 hrs. Excretion: Urine.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.