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.)
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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.)
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NEWS HIGHLIGHTS
Published Studies Related to Arixtra (Fondaparinux Subcutaneous)
Prospective randomized controlled trial on the effect of fondaparinux sodium for prevention of venous thromboembolism after hip fracture surgery. [2009.09]
BACKGROUND: Hip fracture surgery (HFS) carries a high risk of venous thromboembolism (VTE) in the absence of thromboprophylactic treatment. Previous reports have suggested that fondaparinux sodium (FPX) administration decreases the incidence of VTE after HFS and total hip and knee arthroplasties. However, investigations of that effect in Japanese populations remain inadequate. We evaluated the efficacy of FPX after HFS in a prospective randomized controlled trial... CONCLUSIONS: FPX administration demonstrated positive effects on the prevention of VTE after HFS. However, careful postoperative observation is warranted to prevent serious side effects after FPX administration.
Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial. [2009.07.28]
OBJECTIVES: This study sought to evaluate the relative safety and efficacy of fondaparinux and enoxaparin in patients with acute coronary syndromes (ACS) treated with glycoprotein (GP) IIb/IIIa inhibitors or thienopyridines. BACKGROUND: The OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial showed that fondaparinux reduced major bleeding by 50% compared with enoxaparin while preserving similar efficacy. Whether this benefit is consistent in the presence or absence of concurrent antiplatelet therapy with clopidogrel and GP IIb/IIIa inhibitors is unknown... CONCLUSIONS: In patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding and improves net clinical outcome compared with enoxaparin.
Fondaparinux versus Enoxaparin in non-ST-elevation acute coronary syndromes: short-term cost and long-term cost-effectiveness using data from the Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators (OASIS-5) trial. [2009.05]
BACKGROUND: The study aimed to compare the short-term costs and long-term cost-effectiveness of 2 antithrombotics, fondaparinux and enoxaparin, for non-ST-elevation acute coronary syndrome in the United States... CONCLUSIONS: Fondaparinux is a more cost-effective antithrombotic agent than enoxaparin in non-ST-elevation acute coronary syndrome. This is true across the range of event risks seen in OASIS-5.
Fondaparinux compared to enoxaparin in patients with acute coronary syndromes without ST-segment elevation: outcomes and treatment effect across different levels of risk. [2009.03]
BACKGROUND: The OASIS-5 (Organization to Assess Strategies in Ischemic Syndromes-5) trial demonstrated that fondaparinux was noninferior to enoxaparin while reducing the risk of bleeding by 50%. The objectives of our study were to assess the effects of fondaparinux compared to enoxaparin in patients stratified by their Global Registry of Acute Coronary Events (GRACE) score and to examine the ability of the GRACE score to predict bleeding in patients with acute coronary syndromes (ACS)... CONCLUSION: The GRACE score predicted both bleeding and mortality in patients with ACS. The efficacy and safety of fondaparinux were consistent in all risk groups supporting its use in a broad range of ACS patients.
Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non-ST-segment elevation acute coronary syndromes: an individual patient-level combined analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials. [2008.11.11]
CONCLUSIONS: Compared with a heparin-based strategy, fondaparinux reduced mortality, ischemic events, and major bleeding across the full spectrum of acute coronary syndromes and was associated with a more favorable net clinical outcome in patients undergoing either an invasive or a conservative management strategy.
Clinical Trials Related to Arixtra (Fondaparinux Subcutaneous)
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.
Is Using Fondaparinux (Blood Thinner) to Treat Lung Clot Cheaper Than Traditional Therapy [Withdrawn]
This study compares two blood thinners which are both accepted standard cares, fondaparinux
and unfractionated heparin (UFH). These drugs are used to prevent the growth of existing
blood clots and formation of additional blood clots in patients with pulmonary embolism (a
blood clot in the lung) as they are beginning to take warfarin (another standard care blood
thinner). Patients will be invited to participate because they have been diagnosed with a
pulmonary embolism, require anticoagulation therapy (treatment with a blood thinner), and are
currently hospitalized.
The purpose of this study is to determine if patients treated with fondaparinux will have
shorter hospital stays and lower costs of treatment while in the hospital than similar
patients receiving a different standard care with UFH. Fondaparinux is already approved by
the FDA for use in patients with pulmonary embolism, for both inpatient and outpatient care,
as long as treatment is begun with warfarin while they are hospitalized. It is therefore not
an experimental treatment. The study is being conducted to determine which FDA approved
treatment is the best practice for hospital treatment of pulmonary embolism. The study will
also examine the safety and effectiveness of fondaparinux in local use.
ARIXTRA Local Study For Registration In China. [Completed]
Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression [Recruiting]
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.
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.
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