Parenteral Acute ST segment elevation myocardial infarction
Adult: In patients who are managed with thrombolytics or who are initially to be given no other form of reperfusion therapy: Initially, 2.5 mg as a single dose via IV infusion or inj, then subsequent doses of 2.5 mg once daily given via SC inj. Continue treatment for up to 8 days or until discharge if sooner. Treatment is stopped 24 hours before CABG surgery and restarted 48 hours post-surgery.
Subcutaneous Prophylaxis of venous thromboembolism
Adult: In patients undergoing major orthopaedic surgery of hip or leg, or abdominal surgery: Initially, 2.5 mg once daily, starting 6-8 hours after surgery, continued for 5-9 days or up to 32 days in hip surgery. In high-risk patients, doses are given for 6-14 days.
Subcutaneous Superficial vein thrombosis
Adult: In patients weighing ≥50 kg: Initially, 2.5 mg once daily for at least 30 days. Max: 45 days for high-risk patients. Treatment is stopped 24 hours before surgery and restarted at least 6 hours post-surgery.
Adult: For the treatment of cases in patients whom urgent (<120 minutes) invasive management is not indicated: 2.5 mg once daily for up to 8 days or until discharge if sooner. Treatment is stopped 24 hours before CABG surgery and restarted 48 hours post-surgery.
Subcutaneous Deep vein thrombosis, Pulmonary embolism
Adult: For the treatment of acute cases in patients weighing <50 kg: 5 mg; 50-100 kg: 7.5 mg; >100 mg: 10 mg. All doses are given once daily. Initiate concomitant oral anticoagulation treatment as soon as possible (usually within 72 hours). Continue treatment for at least 5 days and until adequate oral anticoagulant effect is established. Usual treatment duration: 5-9 days.
Renal Impairment
Subcutaneous: Prophylaxis of venous thromboembolism; Superficial vein thrombosis
CrCl (mL/min)
Dosage
<20
Contraindicated.
20-50
1.5 mg once daily.
Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Active clinically significant bleeding, bacterial endocarditis, thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of fondaparinux Na. Patients weighing <50 kg (VTE prophylaxis). Severe renal impairment.
Special Precautions
Patient with risk factors for bleeding (e.g. congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, uncontrolled arterial hypertension, haemorrhagic stroke, recent intracranial haemorrhage, thrombocytopenia or platelet defects, diabetic retinopathy; use after brain, spinal, or ophthalmology surgery); history of heparin induced thrombocytopenia; body weight <50 kg. Patient receiving neuraxial anaesthesia (e.g. epidural or spinal anaesthesia) or spinal puncture; risk factors for epidural or spinal haematomas (e.g. use of indwelling epidural catheters, history of spinal deformity or spinal surgery, history of traumatic or repeated epidural or spinal punctures). Not recommended for monotherapy during percutaneous coronary intervention (PCI). Severe hepatic and mild to moderate renal impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Haemorrhage, thrombocytopenia; guiding-catheter thrombosis (use during PCI). Rarely, thrombocytopenia with thrombosis similar to heparin-induced thrombocytopenia. Risk of spinal or epidural haematomas, including long-term or permanent paralysis with neuraxial anaesthesia or spinal puncture. Blood and lymphatic system disorders: Anaemia. Gastrointestinal disorders: Nausea, vomiting. General disorders and administration site conditions: Oedema, peripheral oedema, pain, fever, chest pain, wound secretion. Hepatobiliary disorders: Abnormal LFTs, increased hepatic enzymes. Immune system disorders: Rarely, allergic reactions (e.g. angioedema, anaphylaxis). Nervous system disorders: Headache. Reproductive system and breast disorders: Utero-vaginal haemorrhage. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Erythematous rash, pruritus. Vascular disorders: Haemarthrosis, bruise, haemoptysis, haematuria, haematoma, gingival bleeding, purpura, epistaxis.
Monitor CBC, platelet count, serum creatinine. Perform occult blood testing of stools. Measure anti factor Xa activity with an assay particularly calibrated for fondaparinux. Assess for signs and symptoms of haemorrhage; neurologic impairment (in patients undergoing neuraxial procedures).
Increased risk of bleeding with desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, LMWH.
Lab Interference
Antifactor Xa activity of fondaparinux should not be calibrated with international standards of heparin or LMWH.
Action
Description: Mechanism of Action: Fondaparinux sodium, a synthetic pentasaccharide, is a selective inhibitor of activated Factor X (Xa). It potentiates the neutralisation of Factor Xa by selectively binding to antithrombin III thereby interrupting blood coagulation cascade and inhibiting both thrombin formation and thrombus development. Pharmacokinetics: Absorption: Rapidly and completely absorbed after SC inj. Bioavailability: 100% (SC). Time to peak plasma concentration: Approx 2-3 hours (SC). Distribution: Volume of distribution: 7-11 L, mainly in blood. Plasma protein binding: ≥94% to antithrombin III. Excretion: Via urine (64-77% as unchanged drug). Elimination half-life: 17-21 hours.
Chemical Structure
Fondaparinux sodium Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 636380, Fondaparinux Sodium. https://pubchem.ncbi.nlm.nih.gov/compound/Fondaparinux-Sodium. Accessed Mar. 25, 2024.
B01AX05 - fondaparinux ; Belongs to the class of other antithrombotic agents.
References
Anon. Fondaparinux. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/02/2024.Arixtra 1.5 mg/0.3 mL Solution for Injection, Pre-filled Syringe (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 13/02/2024.Arixtra 2.5 mg/0.5 mL Solution for Injection (Aspen Medical Products Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 13/02/2024.Arixtra 2.5 mg/0.5 mL Solution for Injection, Pre-filled Syringe (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 13/02/2024.Arixtra 5 mg/0.4 mL and 7.5 mg/0.6 mL (Aspen Medical Products Malaysia Sdn Bhd). MHRA. https://www.npra.gov.my. Accessed 13/02/2024.Arixtra 7.5 mg/0.6 mL Solution for Injection, Pre-filled Syringe (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 13/02/2024.Buckingham R (ed). Fondaparinux Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/02/2024.Fondaparinux Sodium Injection (Dr. Reddy’s Laboratories Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/02/2024.Joint Formulary Committee. Fondaparinux Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/02/2024.
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