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1. Drugs. 2012 May 7;72(7):987-1007. doi: 10.2165/11207480-000000000-00000.

Octocog alfa, antihaemophilic factor (recombinant), plasma/albumin free method
(advate®): a review of its use in the management of patients with haemophilia a.

Dhillon S.

Adis, Auckland, New Zealand.

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.

PMID: 22564135 [PubMed - in process]