Fondaparinux
Dosing in kidney impairment
Renal Impairment Patients with impaired renal function are at increased risk of bleeding due to reduced clearance of fondaparinux sodium [see Contraindications and Warnings and Precautions]. Assess renal function periodically in patients receiving fondaparinux sodium . Discontinue fondaparinux sodium immediately in patients who develop severe renal impairment while on therapy.
After discontinuation of fondaparinux sodium , its anticoagulant effects may persist for 2 to 4 days in patients with normal renal function (i.e., at least 3 to 5 half-lives). The anticoagulant effects of fondaparinux sodium may persist even longer in patients with renal impairment [see Clinical Pharmacology].
Dosing in liver impairment
Hepatic Impairment No dose adjustment is recommended in patients with mild to moderate hepatic impairment, based upon single-dose pharmacokinetic data. Pharmacokinetic data are not available for patients with severe hepatic impairment. Patients with hepatic impairment may be particularly vulnerable to bleeding during fondaparinux sodium therapy.
Observe these patients closely for signs and symptoms of bleeding. [See Clinical Pharmacology.]
Preparation and administration
2 DOSAGE AND ADMINISTRATION For subcutaneous use, do not mix with other injections or infusions. Prophylaxis of deep vein thrombosis: fondaparinux sodium 2.5 mg subcutaneously once daily after hemostasis has been established. The initial dose should be given no earlier than 6 to 8 hours after surgery and continued for 5 to 9 days.
For patients undergoing hip fracture surgery, extended prophylaxis up to 24 additional days is recommended. ( 2.2 , 2.3 ) Treatment of deep vein thrombosis and pulmonary embolism:fondaparinux sodium 5 mg (body wright < 50 kg), 7.5mg (50 to 100 kg), or 100 mg (>100 kg) subcutaneously once daily. Treatment should continue for at least 5 days until INR 2 to 3 achieved with warfarin sodium. 2.1 Important Dosing Information Do not mix other medications or solutions with fondaparinux sodium injection.
Prior to administration, visually inspect fondaparinux sodium injection to ensure the solution is clear and free of particulate matter. To avoid the loss of drug when using the prefilled syringe, do not expel the air bubble from the syringe before the injection. Administration should be made in the fatty tissue, alternating injection sites (e.g., between the left and right anterolateral or the left and right posterolateral abdominal wall).