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Arixtra (Fondaparinux Sodium Subcutaneous) - Summary

 
 



SPINAL/EPIDURAL HEMATOMAS

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids, or fondaparinux sodium for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (see also WARNINGS: Hemorrhage and PRECAUTIONS: Drug Interactions.)

 

ARIXTRA SUMMARY

ARIXTRA®
(fondaparinux sodium)
Injection

ARIXTRA® (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl- (1→4)-O-β-D-glucopyra-nuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2- (sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O-sulfo-α-L-idopyranuronosyl- (1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt.

ARIXTRA Injection is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism:

  • 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.

ARIXTRA Injection is indicated for:

  • the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium, and
  • the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

(See DOSAGE AND ADMINISTRATION section for appropriate dosage regimen.)


See all Arixtra indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Arixtra (Fondaparinux Subcutaneous)

FONDAPARINUX FOR ISOLATED SUPERFICIAL-VEIN THROMBOSIS OF THE LEGS: A COST-EFFECTIVENESS ANALYSIS. [2011.07.14]
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 Subcutaneous)

Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer [Recruiting]
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.

Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT) [Recruiting]
The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).

Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers [Completed]
Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as for the treatment of DVT and pulmonary embolism (PE). As with many medications, therapeutic dosages have not been fully investigated for the morbidly obese population. Our goal is to study the therapeutic blood levels, after 2 different dosages of the medication are given to morbidly obese volunteers. We will recruit 21 morbidly obese (Body Mass Index (BMI) > 35) individuals who are in the evaluation process

for bariatric surgery. They will be divided into 7 groups: 3 participants with BMI 35 - 39. 9,

3 with a BMI of 40 - 49. 9, 3 with a BMI of 50 - 59. 9, 3 with a BMI > 60, 3 with a weight of

100 - 149 KG, 3 with a weight of 150 - 199 KG and 3 with a weight of 200 - 249 KG.

Participants will be administered two different doses of the medication with a 2-week interval in between, then blood will be drawn in various intervals throughout the next 48 hours to see which dose provides the best therapeutic levels. Participants will be monitored closely for any side effects or complications.

A Pilot Study Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients [Recruiting]
This pilot study is designed to determine the feasibility of conducting a randomized clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.

Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients [Recruiting]
A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.

more trials >>

Reports of Suspected Arixtra (Fondaparinux Subcutaneous) 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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