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Arixtra (Fondaparinux Sodium Injection) - Summary



Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

● use of indwelling epidural catheters

● concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants

● a history of traumatic or repeated epidural or spinal puncture

● a history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.

Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis. [See Warnings and Precautions and Drug Interactions (7).]



ARIXTRA (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa).

Prophylaxis of Deep Vein Thrombosis

ARIXTRA® is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):

  • in patients undergoing hip fracture surgery, including extended prophylaxis;
  • in patients undergoing hip replacement surgery;
  • in patients undergoing knee replacement surgery;
  • in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
Treatment of Acute Deep Vein Thrombosis

ARIXTRA is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.

Treatment of Acute Pulmonary Embolism

ARIXTRA is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

See all Arixtra indications & dosage >>


Published Studies Related to Arixtra (Fondaparinux Injection)

ABSTRACT BACKGROUND: According to a recent randomized controlled trial (CALISTO), prophylactic fondaparinux can prevent thrombotic complications following superficial vein thrombosis (SVT). The cost-effectiveness of this treatment remains to be determined... CONCLUSION: Fondaparinux for 45 days does not appear to be cost-effective when used in all patients with isolated SVT of the legs. A better value for money could be obtained in subgroups of patients with a higher incidence of VTE after SVT. Shorter durations of treatment should be further evaluated in future clinical studies.

Effect of edoxaban on markers of coagulation in venous and shed blood compared with fondaparinux. [2011.06.06]
Edoxaban, an oral direct factor Xa (FXa) inhibitor, is in phase III clinical development for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. The shed blood model allows for study of activated coagulation at a site of standardised tissue injury due to local release of tissue factor...

Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients. [2011.05.25]
CONCLUSIONS: Once-daily, subcutaneous fondaparinux is as effective and safe without monitoring as adjusted-dose intravenous UFH for the initial treatment of acute PE and DVT in Japanese patients.

Comparison of safety and efficacy between fondaparinux and nadroparin in non-ST elevation acute coronary syndromes. [2011.03]
BACKGROUND: American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC) guidelines gave fondaparinux a class I recommendation for use in patients with non-ST elevation acute coronary syndromes (NSTE-ACS) undergoing invasive or conservative strategy. Nadroparin is one of the common anticoagulants used in NSTE-ACS in China. Accordingly, this study compared the safety and efficacy between fondaparinux and nadroparin in patients with NSTE-ACS... CONCLUSION: Fondaparinux resulted in a nonsignificant risk reduction in patients with NSTE-ACS in both bleeding and ischaemic events during short- and long-term follow-up compared with nadroparin.

Early postoperative bleeding in polytrauma patients treated with fondaparinux: literature review and institutional experience. [2011.01]
Surgery for pelvic or acetabular fractures carries a high risk of deep-vein thrombosis (DVT). Reports indicate that fondaparinux is a more effective thromboprophylactic agent than low molecular weight heparin (LMWH) after major orthopaedic surgery... The current report supports that fondaparinux, in patients with pelvic and acetabular fractures, can be equally effective as enoxaparin and not associated with adverse bleeding events.

more studies >>

Clinical Trials Related to Arixtra (Fondaparinux Injection)

ARIXTRA Local Study For Registration In China. [Completed]

Study of Arixtra to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy [Terminated]
This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer [Completed]
There is a direct association between cancer and thrombosis (blood clots). The purpose of this study is to determine the best dose of an antithrombotic (prevents blood clots) agent called fondaparinux in non-small cell lung cancer(NSCLC). Patients will also receive chemotherapy.

Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism [Completed]
The objective of this retrospective study is to gather information about how fondaparinux is used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous thromboembolism (VTE) in order to fill an information gap concerning the off-label use of fondaparinux during pregnancy.

Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression [Withdrawn]
The purpose of this study is to assess feasibility and safety of using once daily Fondaparinux Sodium (ARIXTRA) in patients with ovarian cancer who are in 'clinical remission' (no clinical evidence of disease) after chemotherapy but at high risk of ovarian cancer recurrence.

more trials >>

Reports of Suspected Arixtra (Fondaparinux Injection) Side Effects

Haematoma (78)Anaemia (61)Muscle Haemorrhage (45)Incorrect Drug Administration Duration (45)OFF Label USE (36)Haemorrhage (32)Haemoglobin Decreased (32)Death (27)Subdural Haematoma (27)Cerebral Haemorrhage (25)more >>

Page last updated: 2011-12-09

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