FONDAPARINUX SODIUM
Fondaparinux sodium is an anticoagulant used to prevent deep vein thrombosis in patients undergoing major surgeries, such as hip replacements, knee replacements, and abdominal procedures. It also treats acute deep vein thrombosis and pulmonary embolisms when used in combination with warfarin. This medication helps reduce the risk of blood clots that could lead to a pulmonary embolism, particularly in patients recovering from hip fracture surgery.
How FONDAPARINUX SODIUM Works
This medication works by selectively binding to antithrombin III, which boosts the body's natural ability to neutralize Factor Xa by about 300 times. This process interrupts the blood coagulation cascade, preventing the formation of thrombin and the development of blood clots without impacting platelet function.
Details
- Status
- Prescription
- First Approved
- 2011-07-11
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
FONDAPARINUX SODIUM Approval History
What FONDAPARINUX SODIUM Treats
2 indicationsFONDAPARINUX SODIUM is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Deep Vein Thrombosis
- Pulmonary Embolism
FONDAPARINUX SODIUM Boxed 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 indwel...
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 anticoagula
FONDAPARINUX SODIUM Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
FONDAPARINUX SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in FONDAPARINUX SODIUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FONDAPARINUX SODIUM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FONDAPARINUX SODIUM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06710184 FOXY | DAN-FOXY 2024-517229-18-00 | Ph 4 | recruiting | Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction |
| NCT05001776 | 05-06/21 | Ph 4 | completed | Endovenous Laser Ablation in Acute Thrombophlebitis of the Varicose Great Saphenous Vein |
| NCT00911157 results posted | 111436 | Ph 3 | completed | The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients |
| NCT00843492 FONDACAST results posted | 109350 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FONDAPARINUX SODIUM FDA Label Details
Indications & Usage
FONDAPARINUX SODIUM is indicated for the treatment of Deep Vein Thrombosis; Pulmonary Embolism.
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...
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Full clinical data, patents, trials, and competitive landscape for fondaparinux sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.