The Food and Drug Administration (FDA) has approved an updated labeling for Novoeight, a human antihemophilic factor (human blood coagulation factor VIII).
Specifically, the indication has been changed from “control and prevention of bleeding episodes” to “on-demand treatment and control of bleeding episodes” in adults and children with hemophilia A. Novoeight is also approved for perioperative management and routine prophylaxis to reduce the frequency of bleeding episodes.
In addition, the Warnings and Precautions section has been updated to include more information regarding neutralizing antibodies, which can occur following administration of Novoeight. The labeling states that based on clinical trial data, previously untreated patients (PUPs) are at greatest risk for inhibitor development. In the main phase of the study, 24 of 56 (42.9%) PUPs developed inhibitors with a mean of 14.1 exposure days at the time of the first positive inhibitor test; 26.8% of PUPs developed high titer (≥ 5 BU) inhibitors. High risk genetic mutations were identified in 91.7% of the overall inhibitors and 93.3% of the high titer inhibitors.
All patients treated with Novoeight should be monitored for the development of inhibitors. Testing for factor VIII inhibitors should be performed if the expected plasma levels of factor VIII activity are not attained, or if bleeding is not controlled with an appropriate dose.
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