What it's for (Indications)
- Prophylaxis of deep vein thrombosis (DVT) in adults, particularly after surgery (e.
- g.
- , hip fracture surgery), and treatment of deep vein thrombosis and pulmonary embolism (VTE) in adults.
- Treatment of venous thromboembolism in pediatric patients weighing at least 10 kg.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | For subcutaneous use only; do not mix with other injections or infusions. - **Prophylaxis of DVT in adults**: 2.5 mg subcutaneously once daily, initiated 6-8 hours post-surgery after hemostasis, continued for 5-9 days. For hip fracture surgery, extended prophylaxis up to 24 additional days is recommended. - **Treatment of DVT and PE in adults**: Once daily subcutaneous injection based on body weight: - Less than 50 kg: 5 mg - 50 kg to 100 kg: 7.5 mg - Greater than 100 kg: 10 mg Treatment should continue for at least 5 days until an INR of 2-3 is achieved with warfarin sodium. - **Treatment of VTE in pediatric patients (at least 10 kg)**: 0.1 mg/kg subcutaneously once daily. |
Safety & Warnings
Common Side Effects
- The most serious adverse reactions are bleeding complications.
- Other clinically significant adverse reactions include spinal or epidural hematomas, hemorrhage, renal impairment and bleeding risk, increased bleeding risk in patients weighing less than 50 kg, and thrombocytopenia.
Serious Warnings
- Black Box Warning: WARNING: SPINAL/EPIDURAL HEMATOMAS. Epidural or spinal hematomas may occur in patients who are anticoagulated with 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.
- Risk of epidural or spinal hematomas, potentially leading to long-term or permanent paralysis, in patients receiving neuraxial anesthesia or undergoing spinal puncture while anticoagulated with fondaparinux sodium.
- Factors increasing this risk include concomitant use of other drugs affecting hemostasis, traumatic or repeated epidural/spinal punctures, long indwelling epidural catheters, and a history of spinal deformity or surgery.
- Major hemorrhage risk is increased in patients with conditions predisposing to bleeding.
- Severe renal impairment (CrCl <30 mL/min) significantly increases fondaparinux plasma levels and bleeding risk.
- Patients weighing less than 50 kg have an increased risk of bleeding.
- Thrombocytopenia, including immune-mediated thrombocytopenia, has been reported.
- Monitor complete blood counts regularly.
How it Works (Mechanism of Action)
Fondaparinux sodium's antithrombotic activity is due to antithrombin III (ATIII)-mediated selective inhibition of Factor Xa. It binds to ATIII, enhancing ATIII's neutralization of Factor Xa by approximately 300 times. This interruption of the coagulation cascade inhibits thrombin formation and thrombus development. It does not inactivate thrombin (activated Factor II) and has no known effect on platelet function, fibrinolytic activity, or bleeding time at recommended doses.
Commercial Brands (Alternatives)
No other brands found for this formula.