Drug Detail:Fondaparinux (Fondaparinux [ fon-dap-a-rin-ux ])
Drug Class: Factor Xa inhibitors
Usual Adult Dose for Deep Vein Thrombosis
Dosage is based on patient's weight:
- Under 50 kg: 5 mg subcutaneously once a day
- 50 to 100 kg: 7.5 mg subcutaneously once a day
- Over 100 kg: 10 mg subcutaneously once a day
Comments:
- Initiate concomitant warfarin as soon as possible, usually within 72 hours.
- Usual duration 5 to 9 days; up to 26 days was administered in trials.
Uses:
- Treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
- Treatment of acute pulmonary embolism (PE) when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
Usual Adult Dose for Pulmonary Embolism
Dosage is based on patient's weight:
- Under 50 kg: 5 mg subcutaneously once a day
- 50 to 100 kg: 7.5 mg subcutaneously once a day
- Over 100 kg: 10 mg subcutaneously once a day
Comments:
- Initiate concomitant warfarin as soon as possible, usually within 72 hours.
- Usual duration 5 to 9 days; up to 26 days was administered in trials.
Uses:
- Treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
- Treatment of acute pulmonary embolism (PE) when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Abdominal Surgery
2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days
Comments:
- Administration earlier than 6 hours after surgery increases risk of major bleeding.
- The usual duration is 5 to 9 days; up to 10 days was administered in trials.
Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
Usual Adult Dose for Deep Vein Thrombosis - Prophylaxis
2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days
Comments:
- Administration earlier than 6 hours after surgery increases risk of major bleeding.
- Up to 11 days DVT prophylaxis was administered in trials.
- For hip fracture surgery, extending prophylaxis up to 24 additional days is recommended; a total of 32 days (perioperative and extended prophylaxis) was administered in trials.
Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, or knee replacement surgery.
Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery
2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days
Comments:
- Administration earlier than 6 hours after surgery increases risk of major bleeding.
- Up to 11 days DVT prophylaxis was administered in trials.
- For hip fracture surgery, extending prophylaxis up to 24 additional days is recommended; a total of 32 days (perioperative and extended prophylaxis) was administered in trials.
Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, or knee replacement surgery.
Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery
2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days
Comments:
- Administration earlier than 6 hours after surgery increases risk of major bleeding.
- Up to 11 days DVT prophylaxis was administered in trials.
- For hip fracture surgery, extending prophylaxis up to 24 additional days is recommended; a total of 32 days (perioperative and extended prophylaxis) was administered in trials.
Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, or knee replacement surgery.
Renal Dose Adjustments
CrCl less than 30 mL/min: Contraindicated
CrCl 30 to 50 mL/min: Use with caution
Discontinue immediately if patient develops severe renal impairment.
Liver Dose Adjustments
Mild to moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Observe closely for signs of bleeding
Dose Adjustments
- Patients weighing less than 50 kg: Contraindicated for DVT prophylaxis; use with caution for DVT/pulmonary embolism treatment
- Discontinue if platelet count falls below 100,000/mm(3)
Precautions
US 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 indwelling epidural catheters
- concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
- a history of traumatic or repeated epidural or spinal puncture
- Optimal timing between administration of fondaparinux 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 benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
Safety and efficacy have not been established in patients younger than 17 years.
Consult WARNINGS section for additional precautions.
Dialysis
Clearance may be increased by up to 20% during chronic intermittent hemodialysis.
Other Comments
Administration advice:
- For subcutaneous use only.
- Patients may self inject if deemed appropriate and trained by their physician.
- Do not expel the air bubble before injection.
- Administer in fatty tissue.
- Alternate injection sites.
Storage requirements: Store at room temperature.
IV compatibility: Do not mix with other medications.
Patient advice:
- If patient had neuraxial anesthesia or spinal puncture, they should watch for and immediately report signs of spinal/epidural hematoma such as back pain, tingling, numbness (especially in lower limbs), muscle weakness, and stool or urine incontinence.
- Watch for signs of bleeding.
- It may take longer than usual to stop bleeding.
- Patients may bruise or bleed more easily.
- Patients should report any unusual bruising, bleeding, or signs of thrombocytopenia (such as rash or dark red spots under the skin).
- Inform other doctors or dentists of use of this product before any surgeries or starting new medications.
- Inform other doctors or dentists of all medications being taken, including over the counter medications.
