Ballicules › Drugs › Fondaparinux
What it is Synthetic pentasaccharide activating antithrombin against factor Xa; VTE prophylaxis and treatment.
Why this one Negligible HIT cross-reactivity makes it a practical anticoagulant when heparin-induced thrombocytopenia is suspected.
What limits it No reliable reversal agent exists; renal accumulation increases bleeding, and neuraxial procedures risk spinal hematoma.
FDA-approved for
VTE prophylaxis/treatment (2001)
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Epidural or spinal hematomas (which may cause long-term or permanent paralysis) may occur with neuraxial anesthesia or spinal puncture in anticoagulated patients.
FDA dosing Population Start Target Max
DVT prophylaxis (hip fracture, hip/knee replacement, abdominal surgery) Adult 2.5 mg SC QD 2.5 mg SC QD 2.5 mg SC QD
DVT/PE treatment, body weight <50 kg Adult 5 mg SC QD 5 mg SC QD 5 mg SC QD
DVT/PE treatment, body weight 50-100 kg Adult 7.5 mg SC QD 7.5 mg SC QD 7.5 mg SC QD
DVT/PE treatment, body weight >100 kg Adult 10 mg SC QD 10 mg SC QD 10 mg SC QD
Renal Contraindicated if CrCl <30 mL/min; use with caution CrCl 30-50 mL/min
Hepatic No adjustment needed (mild to moderate impairment)
Instructions Subcutaneous use only; do not mix with other injections or infusions Prophylaxis initial dose no earlier than 6-8 hours after surgery Prophylaxis duration 5-9 days (up to 24 additional days for hip fracture) Treatment continue ≥5 days until INR 2-3 achieved with warfarin
Contraindications Severe renal impairment (CrCl <30 mL/min) Active major bleeding Bacterial endocarditis Thrombocytopenia with a positive anti-platelet antibody test in the presence of fondaparinux Body weight <50 kg (VTE prophylaxis only)
Cautions Spinal/epidural hematoma Hemorrhage Increased bleeding risk in renal impairment and low body weight <50 kg Thrombocytopenia Not for use as heparin/LMWH substitute for HIT
Adverse reactions Bleeding complications Mild local injection-site irritation Anemia Thrombocytopenia
Pregnancy Published data have not reported a clear association with adverse developmental outcomes; low placental transfer observed.
Lactation Undefined
⚠ BOXED WARNING
Spinal or epidural hematoma with neuraxial anesthesia
Cost, est. cash $4–$300/month
Generic entry 2011
Classes and tags
Clinical profile
Therapeutic safety burden 1 / 4
Overdose danger 1 / 4
Weight-gain liability 0 / 4
Sedation liability 0 / 4
QT / Torsades 0 / 4
Direct muscarinic antagonism 0 / 4
Embryofetal risk 1 / 4
Legacy pregnancy category B
Defining liability Generally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Fondaparinux ballicule
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