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FONDAPARINUX SODIUM
FONDAPARINUX SODIUM is a drug. It is currently FDA-approved (first approved 2001).
At a glance
| Generic name | FONDAPARINUX SODIUM |
|---|---|
| Modality | Oligosaccharide |
| Phase | FDA-approved |
| First approval | 2001 |
Approved indications
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
- Injection site bleeding
- Injection site rash
- Injection site pruritus
- Anemia
- Insomnia
- Increased wound drainage
- Hypokalemia
- Dizziness
- Hypotension
- Confusion
Serious adverse events
- Major bleeding
- Hemorrhage
- Post-operative hemorrhage
- Intracranial bleeding
- Retroperitoneal bleeding
- Intraocular bleeding
- Pericardial bleeding
- Spinal bleeding
- Bullous eruption
- Hematoma
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:
- FONDAPARINUX SODIUM CI brief — competitive landscape report
- FONDAPARINUX SODIUM updates RSS · CI watch RSS
Frequently asked questions about FONDAPARINUX SODIUM
What is FONDAPARINUX SODIUM?
FONDAPARINUX SODIUM is a Oligosaccharide drug.
When was FONDAPARINUX SODIUM approved?
FONDAPARINUX SODIUM was first approved on 2001.
What development phase is FONDAPARINUX SODIUM in?
FONDAPARINUX SODIUM is FDA-approved (marketed).
What are the side effects of FONDAPARINUX SODIUM?
Common side effects of FONDAPARINUX SODIUM include Injection site bleeding, Injection site rash, Injection site pruritus, Anemia, Insomnia, Increased wound drainage. Serious adverse events: Major bleeding, Hemorrhage, Post-operative hemorrhage, Intracranial bleeding.
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing