Jane S. Ricciuti, RPh, MS


July 13, 2004

In This Article


(fondaparinux sodium) Injection

Manufacturer: Fonda BV

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 5/28/04)

New Indication: This supplemental new drug application provides for the use of Arixtra (fondaparinux sodium) injection for the treatment of acute deep vein thrombosis (DVT) without pulmonary embolism (PE) when administered in conjunction with warfarin sodium and for the treatment of acute PE when administered in conjunction with warfarin sodium.

Dosing: For the treatment of patients with acute DVT and acute symptomatic PE, the dose recommendations for subcutaneous once-daily injection of fondaparinux is suggested based on body weight:

  • 5 mg (body weight < 50 kg),

  • 7.5 mg (body weight 50-100 kg), or

  • 10 mg (body weight > 100 kg).

It is recommended that fondaparinux treatment be continued for at least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2.0 to 3.0). Concomitant treatment with warfarin sodium should be initiated as soon as possible, usually within 72 hours. The usual duration of administration of fondaparinux is 5 to 9 days.

Clinical Summary: Two separate clinical trials evaluated the efficacy of fondaparinux for the treatment of acute DVT and PE. In patients with a confirmed diagnosis of acute DVT without PE, 2192 patients were treated with fondaparinux or enoxaparin. The primary efficacy endpoint was confirmed, symptomatic, recurrent venous thromboembolism (VTE), which was reported up to Day 97. Patients on fondaparinux had a 3.9% incidence of VTE vs 4.1% in the control group.

In a second randomized, open-label, clinical trial, 2184 patients with a confirmed diagnosis of acute symptomatic PE, with or without DVT, were treated with fondaparinux or heparin; patients on fondaparinux had a 3.8% incidence of VTE compared with 5.0% in the control group.


Arixtra (fondaparinux sodium) Injection Labeling

Medscape DrugInfo

Arixtra (fondaparinux sodium) Injection


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