Dosage and Administration

Fondaparinux is supplied for use as a pre-filled syringe with attached protective needle system. Individual syringes are available for the following doses: 2.5, 5.0, 7.5 and 10.0 mg. The drug is formulated in an isotonic solution of sodium chloride, with a pH varying between 5.0 and 8.0. The dose studied for thromboprophylaxis was determined by a wide dose-ranging phase II program in orthopedic surgery patients, which led to the selection of a 2.5 mg daily dose (Turpie et al., 2001).

The dose of fondaparinux selected for use in the treatment of venous thromboembolism (VTE) was also selected from a dose-ranging phase II study (Rembrandt Investigators, 2000). Guidance for dose selection was derived from a primary outcome measure of ultrasonographic change in thrombus mass balanced against tolerability data, with the data model supporting a 7.5 mg daily dose. The phase III VTE treatment program validated a simplified weight-based dosing scheme, where patients between 50 and 100 kg received 7.5 mg once-daily. Patients weighing in excess of 100 kg were administered 10.0 mg, whereas patients weighing less than 50 kg received 5.0 mg (Buller et al., 2003, 2004).

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