Fondaparinux Sodium

1 INDICATIONS AND USAGE Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. ( 1.1 ) Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin.

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Spinal or epidural hematomas [see Warnings and Precautions ( 5.1 )] . Hemorrhage [see Warnings and Precautions ( 5.2 )] . Renal impairment and bleeding risk [see Warnings and Precautions ( 5.3 )] . Body weight <50 Kg and bleeding risk [see Warnings and Precautions ( 5.4 )] . Thrombocytopenia [see Warnings and Precautions ( 5.5 )] . The most clinically significant adverse reactions associated with the use of fondaparinux sodium are bleeding complications. ( 6.1 ) Mild local irritation (injection site bleeding, rash and pruritus) may occur following subcutaneous injection.

8.1 Pregnancy Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with fondaparinux sodium and adverse development outcomes. Fondaparinux sodium plasma concentrations obtained from four women treated with fondaparinux sodium during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium (see Data) .

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. 5 WARNINGS AND PRECAUTIONS Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur. ( 5.1 ) Patient taking fondaparinux sodium with risk factors for bleeding are at increased risk of hemorrhage. ( 5.2 ) Bleeding risk is increased in renal impairment and in patients with low body weight 50 kg (5.4% versus 2.1% in patients undergoing hip fracture, hip replacement, or knee replacement surgery; 5.3% versus 3.3% in patients undergoing abdominal surgery). 5.5 Thrombocytopenia Thrombocytopenia can occur with the administration of fondaparinux sodium. Thrombocytopenia of any degree should be monitored closely. Discontinue fondaparinux sodium if the platelet count falls below 100,000/mm3. 4 CONTRAINDICATIONS Fondaparinux sodium injection is contraindicated in the following conditions:( 4 ) Severe renal impairment (creatinine clearance [CrCl] <30 mL/min). [See Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.6 ).] Active major bleeding. Bacterial endocarditis.