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Arixtra (FONDAPARINUX)
Arixtra works by blocking the action of factor Xa, a protein involved in blood clotting.
Arixtra (Fondaparinux) is a factor Xa inhibitor, a small molecule drug that targets coagulation factor X. It is used to treat deep venous thrombosis, prevent deep vein thrombosis, and treat pulmonary thromboembolism. Originally developed by Mylan Ireland Ltd, it remains under their ownership and is off-patent, with multiple generic manufacturers available. Arixtra has a half-life of 19.3 hours and bioavailability of 1%. It was FDA-approved in 2001.
At a glance
| Generic name | FONDAPARINUX |
|---|---|
| Sponsor | Mylan Ireland Ltd |
| Drug class | Factor Xa Inhibitor |
| Target | Coagulation factor X |
| Modality | Oligosaccharide |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2001 |
Mechanism of action
The antithrombotic activity of fondaparinux sodium is the result of antithrombin III (ATIII)-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, fondaparinux sodium potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development.Fondaparinux sodium does not inactivate thrombin (activated Factor II) and has no known effect on platelet function. At the recommended dose, fondaparinux sodium does not affect fibrinolytic activity or bleeding time.
Approved indications
- Deep venous thrombosis
- Prevention of deep vein thrombosis
- Pulmonary thromboembolism
Boxed warnings
- WARNING: SPINAL/EPIDURAL HEMATOMAS 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 Optimal timing between the administration of fondaparinux sodium and neuraxial procedures is not known. 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 ( 5.1 ) and Drug Interactions (7) ] WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning . 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 ( 5.1 ) and Drug Interactions ( 7 )]
Common side effects
- Major bleeding
- Minor bleeding
- Hematoma
- Bullous eruption
- Confusion
- Dizziness
- Hypokalemia
- Increased wound drainage
- Insomnia
- Post-operative hemorrhage
- Purpura
Key clinical trials
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE3)
- Thromboprophylaxis in Lower Limb Immobilisation (PHASE3)
- Hip Fracture Surgery Arterial and Venous Thrombotic Events Prevention (PHASE3)
- Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction (PHASE4)
- Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE) (PHASE3)
- Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care (PHASE3)
- Management of Atrial Fibrillation in Patients With Cancer (MAFIC Study)
- Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Arixtra CI brief — competitive landscape report
- Arixtra updates RSS · CI watch RSS
- Mylan Ireland Ltd portfolio CI