Fondaparinux
- Atc Codes:B01AX05
- CAS Codes:114870-03-0
- PHARMGKB ID:114870-03-0
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Arixtra; Belgium: Arixtra; Bulgaria: Arixtra; Cyprus: Arixtra; Czech Republic: Arixtra; Denmark: Arixtra; Estonia: Arixtra; Finland: Arixtra; France: Arixtra; Germany: Arixtra; Greece: Arixtra; Hungary: Arixtra; Ireland: Arixtra; Italy: Arixtra; Latvia: Arixtra; Lithuania: Arixtra; Luxembourg: Arixtra; Malta: Arixtra; Netherlands: Arixtra; Poland: Arixtra; Portugal: Arixtra; Romania: Arixtra; Slovakia: Arixtra; Slovenia: Arixtra; Spain: Arixtra; Sweden: Arixtra; UK: Arixtra.
North America
Canada: Arixtra; USA: Arixtra.
Latin America
Argentina: Arixtra; Brazil: Arixtra; Mexico: Arixtra.
Asia
Japan: Arixtra.
Drug combinations
Chemistry
Fondaparinux Sodium: C~31~H~43~N~3~Na~10~O~49~S~8~. Mw: 1728.08. Decasodium(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5R,6R)-6-[(2R,3S,4S,5R,6R)-2-carboxylato-4-hydroxy-6-[(2R,3S,4R,5R,6S)-4-hydroxy-6-methoxy-5-(sulfonatoamino)-2-(sulfonatooxymethyl)oxan-3-yl]oxy-5-sulfonatooxyoxan-3-yl]oxy-5-(sulfonatoamino)-4-sulfonatooxy-2-(sulfonatooxymethyl)oxan-3-yl]oxy-3-[(2R,3R,4R,5S,6R)-4,5-dihydroxy-3-(sulfonatoamino)-6-(sulfonatooxymethyl)oxan-2-yl]oxy-4,5-dihydroxyoxane-2-carboxylate. CAS-114870-03-0.
Pharmacologic Category
Anticoagulants, Miscellaneous; Factor Xa Inhibitor. (ATC-Code: B01AX05).
Mechanism of action
Fondaparinux is a synthetic pentasaccharide that causes an antithrombin III-mediated selective inhibition of factor Xa. Neutralization of factor Xa interrupts the blood coagulation cascade and inhibits thrombin formation and thrombus development.
Therapeutic use
Prophylaxis of deep vein thrombosis (DVT) in patients undergoing surgery for hip replacement, knee replacement, hip fracture (including extended prophylaxis following hip fracture surgery), or abdominal surgery (in patients at risk for thromboembolic complications); treatment of acute pulmonary embolism (PE); treatment of acute DVT without PE. Additional Canadian approvals (not approved in U.S.): Unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) for the prevention of death and subsequent MI; ST segment elevation MI (STEMI) for the prevention of death and myocardial reinfarction.
Pregnancy and lactiation implications
Use only if clearly needed in pregnancy. Not recommended during lactation.
Unlabeled use
Prophylaxis of DVT in patients with history of heparin-induced thrombocytopenia.
Contraindications
Hypersensitivity to fondaparinux or any component of the formulation; severe renal impairment (CrCl <30 mL/minute); body weight <50 kg (prophylaxis); active major bleeding; bacterial endocarditis; thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of fondaparinux.
Warnings and precautions
Risk of bleeding may be increased; caution in patients with increased risk of bleeding (bacterial endocarditis; congenital or acquired bleeding disorders; active ulcerative or angiodysplastic GI diseases; severe uncontrolled hypertension; hemorrhagic stroke; or use shortly after brain, spinal, or ophthalmology surgery; in patients treated concomitantly with platelet inhibitors; recent GI bleeding; thrombocytopenia or platelet defects; renal impairment; hepatic impairment; hypertensive or diabetic retinopathy; or in patients undergoing invasive procedures). Risk of major bleeding may be increased if initial dose is administered earlier than recommended (initiation recommended at 6-8 hours following surgery). Do not administer with other agents that increase the risk of hemorrhage unless they are essential for the management of the underlying condition (e.g. warfarin for treatment of venous thromboembolism). Although considered an insensitive measure of fondaparinux activity, there have been postmarketing reports of bleeding associated with elevated APTT. Discontinue if bleeding occurs. Thrombocytopenia has occurred with administration, including reports of thrombocytopenia with thrombosis similar to heparin-induced thrombocytopenia (discontinue therapy if platelets fall to <100000/mm^3^). Use with caution in patients with moderate renal dysfunction (CrCl 30-50 mL/minute); contraindicated in patients with CrCl <30 mL/minute (discontinue if severe dysfunction or labile function develops). Patients with recent or anticipated neuraxial anesthesia (epidural or spinal anesthesia) are at risk of spinal or epidural hematoma and subsequent paralysis (risk is increased by concomitant agents which may alter hemostasis, as well as traumatic or repeated epidural or spinal puncture). The administration of fondaparinux is not recommended prior to and during primary percutaneous coronary intervention (PCI) in patients with STEMI, due to an increased risk for guiding-catheter thrombosis. Patients with UA/NSTEMI or STEMI undergoing any PCI should not receive fondaparinux as the sole anticoagulant. Following sheath removal, fondaparinux therapy should not resume for at least 2 hours in patients with UA/NSTEMI and 3 hours in patients with STEMI. Avoid administration 24 hours before and 48 hours after coronary artery bypass graft (CABG) surgery. Appropriate use for subcutaneous administration; not for I.M. administration.