Fondaparinux Dosage

Usual Adult Dose for Deep Vein Thrombosis

less than 50 kg:
5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

50 to 100 kg:
7.5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

100 or more kg:
10 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

Treatment should be continued for a least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2.0 to 3.0). Concomitant treatment with warfarin should be initiated as soon as possible, usually within 72 hours. The usual duration of therapy is 5 to 9 days, although up to 26 days of therapy has been given.

Usual Adult Dose for Pulmonary Embolism

less than 50 kg:
5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

50 to 100 kg:
7.5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

100 or more kg:
10 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

Treatment should be continued for a least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2.0 to 3.0). Concomitant treatment with warfarin should be initiated as soon as possible, usually within 72 hours. The usual duration of therapy is 5 to 9 days, although up to 26 days of therapy has been given.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Abdominal Surgery

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing abdominal surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of administration is 5 to 9 days, and up to 10 days of therapy has been administered.

Usual Adult Dose for Deep Vein Thrombosis - Prophylaxis

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing hip fracture, hip replacement or knee replacement surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of therapy is 5 to 9 days, and up to 11 days therapy has been tolerated. In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (perioperative and extended prophylaxis) has been tolerated.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing hip fracture, hip replacement or knee replacement surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of therapy is 5 to 9 days, and up to 11 days therapy has been tolerated. In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (perioperative and extended prophylaxis) has been tolerated.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing hip fracture, hip replacement or knee replacement surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of therapy is 5 to 9 days, and up to 11 days therapy has been tolerated. In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (perioperative and extended prophylaxis) has been tolerated.

Renal Dose Adjustments

CrCl less than 30 mL/min: drug is contraindicated
CrCl greater 30 and less than 50 mL/min: use with caution - 2.5 mg subcutaneously once a day

Liver Dose Adjustments

Data not available

Dose Adjustments

Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing hip fracture, hip replacement, knee replacement, or abdominal surgery.

Precautions

When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids or fondaparinux for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

Use is contraindicated in patients with active major bleeding, bacterial endocarditis, and in patients with thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of fondaparinux.

Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, the drug should be discontinued.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Clearance may be increased by up to 20% during chronic intermittent hemodialysis.

Other Comments

Use with caution in patients with bleeding disorders, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, and hemorrhage.

Use with caution in elderly patients.

Periodic routine complete blood counts (including platelet count), serum creatinine level, and stool occult blood tests are recommended.

The anticoagulant effects of fondaparinux are not neutralized by protamine sulfate; however, recombinant factor VIIa may reverse these effects.

Fondaparinux does not significantly affect activated partial thromboplastin time (aPTT), prothrombin time (PT), antithrombin levels, or bleeding time; therefore, does not require laboratory monitoring.

Fondaparinux may be a useful alternative to heparin and low molecular weight heparins for prophylaxis and treatment of thrombosis in patients with a history of heparin-induced thrombocytopenia (HIT).

See also...