Prophylaxis or on-demand therapy with octocog alfa, antihemophilic factor, plasma/albumin-free method (Advate(®)) is effective for the prevention and treatment of bleeding episodes and for perioperative management in pediatric and adult patients with hemophilia A. Routine prophylaxis with Advate(®) also prevents bleeding episodes in patients with hemophilia A; moreover, routine prophylaxis with Advate(®) is more effective in preventing bleeding episodes than on-demand therapy. Advate(®) is generally well tolerated in patients with hemophilia A. Serious adverse events with Advate(®) therapy include the development of high-titer factor VIII inhibitors (usually in previously untreated patients) and hypersensitivity reactions. There are no comparative trials of Advate(®) and other factor VIII concentrates. Nevertheless, current evidence indicates that Advate(®) is an effective option for the management of pediatric and adult patients with hemophilia A.