Labeling for Hereditary Factor X Deficiency Treatment Coagadex Updated

The FDA has approved an expanded indication for perioperative management of bleeding
The FDA has approved an expanded indication for perioperative management of bleeding

The Food and Drug Administration (FDA) has approved updated labeling for Coagadex (coagulation factor X [human]; Bio Products Laboratory) to remove age restrictions for the currently approved indications and to add an indication for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. In addition, the FDA has approved an expanded indication for perioperative management of bleeding to include patients with moderate hereditary Factor X deficiency.

Coagadex is now indicated in adults and children with hereditary Factor X deficiency for:

  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency

In an open-label, non-randomized clinical trial, the use of Coagadex in routine prophylaxis of bleeding episodes was evaluated in 9 children <12 years of age. Investigators' assessment following 6 months of routine prophylaxis was rated "excellent" (no minor or major bleeds during the study period) in all 9 subjects. In addition, 22 infusions were given to treat a bleed, equivalent to 2.1 bleeds per subject per year; all bleeds were treated with a single infusion and recorded efficacy ratings were categorized as "excellent" (ie, bleeding stopped with 12 hours).

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For more information visit FDA.gov.