Fondaparinux contraindications

Fondaparinux has been used for the treatment of DVT and PE in two large Phase III trials and is approved by the FDA for these indications. Fondaparinux is as safe and effective as IV UFH for the treatment of PE and SC LMWH for DVT treatment.36,40 The recommended dose for fondaparinux in the treatment of VTE is based on the patient s weight (Table 7-3). Fondaparinux is renally eliminated and accumulation can occur in patients with renal dysfunction. Due to the lack of specific dosing guidelines, fondaparinux is contraindicated in patients with severe renal impairment (CrCl less than 30 mL/minute). Baseline renal function should be measured and monitored closely during the course... 

Renal function impairment The risk of hemorrhage increases with increasing renal impairment. Fondaparinux is contraindicated in patients with severe renal impairment (Ccr less than 30 mL/min). Use with caution in patients with moderate renal impairment (Ccr 30 to 50 mL/min). 

Contraindications Active major bleeding, bacterial endocarditis, body weight less than 50 kg, severe renal impairment (with creatinine clearance less than 30 ml/min), thrombocytopenia associated with antiplatelet antibody formation in the presence of fondaparinux... 

Adverse effects. When bleeding is induced by heparin, the heparin action can be instantly reversed by protamine. Against fractionated heparins and fondaparinux, protamine is less or not effective. Heparin-induced thrombocytopenia type II (HIT II) is a dangerous complication. It results from formation of antibodies that precipitate with bound heparin on platelets. The platelets aggregate and give rise to vascular occlusions. Because of the thrombocytopenia, hemorrhages may occur. Fondaparinux is also contraindicated in HIT II. 

In the absence of contraindications, the treatment of VTE initially should include a rapid-acting anticoagulant (e.g., unfractionated heparin [UFH], a low-molecular-weight heparin [LMWH], or fondaparinux) overlapped with warfarin for at least 5 days and until the patient s international normalized ratio (INR) is greater than 2.0. Anticoagulation therapy should be continued for a minimum of 3 months. The duration of anticoagulation therapy should be based on the patient s risk of VTE recurrence and major bleeding. 

The primary adverse effect associated with fondaparinux therapy is bleeding." " The rate of major bleeding in the VTE prophylaxis trials was approximately 2% to 3%. The risk of major bleeding appears to be related to weight therefore, in patients who weigh less than 50 kg, fondaparinux is contraindicated for VTE prophylaxis, and the treatment dose is only 5 mg every 24 hours. Similar to UFH and the LMWHs, fondaparinux should be used with extreme caution in patients with neuraxial anesthesia or following a spinal puncture owing to the risk for spinal or epidural hematoma formation. Unlike UFH and the LMWHs, fondaparinux does not cause heparin-induced thrombocytopenia and does not produce cross-sensitivity in vitro." A specific antidote to reverse the antithrombotic activity of fondaparinux is not currently available, but several potential products have been evaluated. 

Fondaparinux has been used safely in elderly patients, but the risk of major bleeding increases with age (1.8% in patients younger than 65 years of age, 2.2% in patients 65 to 74 years of age, and 2.7% in patients 75 years of age or older).This is an important consideration because many patients who undergo orthopedic surgery are elderly. Elderly patients are also more likely to have decreased renal function, and careful assessment of renal status should be conducted prior to initiating therapy. Fondaparinux is contraindicated in patients with a creatinine clearance of less than 30 mL/min. 

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