Octocog alfa, antihaemophilic factor, plasma/albumin free method (Advate®) is a recombinant, human, full-length coagulation factor VIII that does not contain human- or animal-derived plasma proteins. It is indicated for the control and prevention of bleeding episodes, for perioperative management and for routine prophylaxis in children and adults with haemophilia A. This article reviews the pharmacological properties, therapeutic efficacy and tolerability of Advate® in these patients. In previously treated paediatric and adult patients with moderately severe or severe haemophilia A, Advate® administered prophylactically, on demand or during surgery was effective for the prevention and treatment of bleeding episodes in three pivotal, uncontrolled clinical trials. The haemostatic efficacy of Advate® in these trials was rated as 'excellent' or 'good' in most bleeding episodes, with the majority of episodes being managed with one infusion. These findings were supported by pooled analyses of clinical trials and routine clinical practice studies, including the Post-Authorization Safety Study. Additionally, in a comparative study, routine prophylaxis with Advate® administered in a standard regimen or in a pharmacokinetic-tailored regimen was effective for the prevention of bleeding episodes in patients with moderately severe or severe haemophilia A, with no significant difference between the two regimens in terms of efficacy. Moreover, any routine prophylaxis with Advate® was found to be more effective in preventing bleeding episodes than on-demand therapy with Advate®. Advate® was generally well tolerated in clinical trials and postmarketing studies, with the most common treatment-emergent adverse events being pyrexia and headache. Serious adverse events with Advate® therapy are development of high-titre factor VIII inhibitors (usually in previously untreated patients) and hypersensitivity reactions. As expected, the incidence of factor VIII inhibitors (any titre) appeared to be lower in previously treated patients (≤ 1.8%) than in previously untreated patients (≤ 20%). There are no head-to-head comparative trials of Advate® and other factor VIII concentrates. Nevertheless, current evidence indicates that Advate® is an effective option for the management of paediatric and adult patients with haemophilia A.