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fondaparinux sodium

Arixtra · ATC code B01AX05

Also known as: Fondaparinux-Natrium

Key facts
Active substance
fondaparinux sodium
Drug class
Antithrombotic
ATC code
B01AX05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe. · Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe. · Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe. · Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe. · Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe.
Marketing authorisation holder
Viatris Healthcare Limited
Information as of
2026-10-27

Key facts

Fondaparinux sodium (Arixtra) is a synthetic anticoagulant given by subcutaneous injection. It is used to prevent and treat venous thromboembolism and in acute coronary syndromes.

What it is used for

  • Arixtra 1.5 mg and 2.5 mg: prevention of VTE in major orthopaedic surgery of the lower limbs, high-risk abdominal surgery and immobilised medical patients
  • Arixtra 1.5 mg and 2.5 mg: acute symptomatic superficial-vein thrombosis of the lower limbs without concomitant DVT
  • Arixtra 2.5 mg: UA/NSTEMI without urgent invasive management, and STEMI managed with thrombolytics or no other reperfusion
  • Arixtra 5 mg, 7.5 mg and 10 mg: treatment of acute DVT and pulmonary embolism (except haemodynamically unstable patients)

Dosing

  • VTE prevention after surgery: 2.5 mg once daily subcutaneously, first dose 6 hours after surgical closure once haemostasis is established; at least 5 to 9 days
  • Prevention with creatinine clearance 20 to 50 ml/min: reduce to 1.5 mg once daily
  • Superficial-vein thrombosis: 2.5 mg once daily for a minimum of 30 and maximum of 45 days
  • UA/NSTEMI and STEMI: 2.5 mg once daily for up to 8 days or until discharge; in STEMI the first dose is intravenous
  • DVT/PE treatment: 7.5 mg once daily; < 50 kg 5 mg, > 100 kg 10 mg; at least 5 days and until oral anticoagulation is established (INR 2 to 3)
  • Not recommended in children below 17 years; further details in the full product information

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Active clinically significant bleeding
  • Acute bacterial endocarditis
  • Severe renal impairment: creatinine clearance < 20 ml/min (1.5 mg and 2.5 mg) or < 30 ml/min (5 mg, 7.5 mg, 10 mg)

Important warnings

  • For subcutaneous use only; do not give intramuscularly
  • Caution with increased bleeding risk (e.g. bleeding disorders, active ulcerative GI disease, recent intracranial haemorrhage or brain, spinal or eye surgery)
  • Elderly patients, body weight < 50 kg and renal impairment: increased bleeding risk
  • Not recommended for superficial-vein thrombosis in patients under 50 kg

Side effects

  • Most common serious reactions: bleeding complications (rarely intracranial and retroperitoneal) and anaemia
  • Thrombocytopenia, thrombocythaemia, coagulation disorders
  • Allergic reactions, very rarely angioedema or anaphylaxis

Interactions

  • Increased bleeding risk with agents that enhance haemorrhage
  • For VTE prevention, not to be combined with desirudin, fibrinolytics, GP IIb/IIIa antagonists, heparin, heparinoids or LMWH
  • Antiplatelet agents and NSAIDs with caution and close monitoring

Pregnancy and breastfeeding

  • No adequate data in pregnant women; should not be prescribed unless clearly necessary
  • Breast-feeding is not recommended during treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ArixtraViatris Healthcare Limited · EMEA/H/C/000403

Source: European Medicines Agency (EMA), product information

Germany

  • Fondaparinux-Natrium BetaBetapharm Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • ArixtraVLD DANIŞMANLIK TIBBİ ÜRÜNLER VE TANITIM HİZMETLERİ LTD. ŞTİ. · 7 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 5 more European countries
France
Fondaparinux Sodique Aspen
Iceland
Arixtra
Ireland
Fondaparinux Sodium Aspen
Liechtenstein
Arixtra
Norway
Arixtra

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Arixtra – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/arixtra-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC B01AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.