Fondaparinux sodium


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery 2.5 mg once daily, 6-8 hr after surgery, continue for 5-9 days. Venous thromboembolism <50 kg: 5 mg once daily, 50-100 kg: 7.5 mg once daily; >100 kg: 10 mg once daily. Duration: 5-9 days, or until oral anticoagulation is established. Superficial vein thrombosis 2.5 mg once daily for 30-45 days.
Dosage Details
Subcutaneous
Superficial vein thrombosis
Adult: 2.5 mg once daily for 30-45 days.

Subcutaneous
Venous thromboembolism
Adult: <50 kg: 5 mg once daily; 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.

Subcutaneous
Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery
Adult: 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.
Renal Impairment
Subcutaneous:
Venous thromboembolism
CrCl (mL/min) Dosage
<30 Contraindicated.
Superficial vein thrombosis; Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery
CrCl (mL/min) Dosage 
<20  Contraindicated. 
20-50  1.5 mg once daily. 
Contraindications
Active major bleeding, bacterial endocarditis, history of heparin-induced thrombocytopenia. Patient weighing <50 kg and who are to undergo hip fracture, hip replacement, knee replacement or abdominal surgery. Severe renal impairment (CrCl <20 mL/min if used in venous thromboembolism (VTE) prophylaxis and treatment of superficial vein thrombosis; CrCl <30 mL/min in the treatment of VTE).
Special Precautions
Patient w/ increased risk of haemorrhage (e.g. congenital or acquired bleeding disorders, history or active GI ulceration, intracranial haemorrhage, recent brain, spinal or ophth surgery); body wt <50 kg. Increased risk of spinal or epidural haematomas in patient undergoing neuraxial (spinal/epidural) anaesth or spinal puncture esp w/ post-op use of indwelling epidural catheters and concurrent use of medications affecting haemostasis. Moderate renal and severe hepatic impairment. Pregnancy and lactation.
Adverse Reactions
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.
Potentially Fatal: Epidural or spinal haematomas that may result in permanent paralysis.
Parenteral/SC: B
MonitoringParameters
Monitor CBC, platelet count, serum creatinine and stool occult blood regularly.
Overdosage
Symptoms: Haemorrhagic complications. Management: Discontinue treatment and initiate suitable therapy (e.g. surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis).
Drug Interactions
Increased risk of bleeding w/ (e.g. desirudin, fibrinolytic drugs, glycoprotein IIb/IIIa-receptor antagonists, heparin, heparinoids or LMWH).
Action
Description: 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.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed. Bioavailability: 100%. Time to peak plasma concentration: 2-3 hr.
Distribution: Volume of distribution: 7-11 L. Plasma protein binding: ≥94% (mainly to antithrombin III).
Excretion: Via urine (64-77% as unchanged drug). Elimination half-life: 17-21 hr.
Chemical Structure

Chemical Structure Image
Fondaparinux sodium

Source: National Center for Biotechnology Information. PubChem Database. Fondaparinux sodium, CID=636380, https://pubchem.ncbi.nlm.nih.gov/compound/Fondaparinux-sodium (accessed on Jan. 21, 2020)

Storage
Store below 25°C. Do not freeze.
References
Anon. Fondaparinux. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/08/2014.

Arixtra Injection, Ssolution (GlaxoSmithkline LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 15/08/2014.

Buckingham R (ed). Fondaparinux Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/08/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Fondaparinux Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 15/08/2014.

Disclaimer: This information is independently developed by MIMS based on Fondaparinux sodium from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Fondaparinux DRL
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in