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Fondaparinux sodium

Arixtra · ATC code B01AX05

Also known as: Fondaparinux-Natrium, Fondaparinuks sodyum, Fondaparinux sodico, Fondaparinux sodique, Fondaparinux sódico

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 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. 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.