The Food and Drug Administration (FDA) has approved a revised product label for Octaplas (Octapharma), Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion.

The new label includes data from a post-marketing study that assessed safety, efficacy and tolerability in treating critically ill pediatric patients. The approval was based on the results of a single-arm, multicenter, open-label post-marketing study that assessed 50 patients aged 16 years and under; 40 cardiac surgery patients, 5 liver transplant/dysfunction patients, 4 sepsis-related coagulopathy patients and 1 patient with hypoxic encephalopathy. The primary outcome measures were the number of patients with adverse drug reactions, thromboembolic events and hyperfibrinolytic events up to 6 days post-infusion.

Results demonstrated the overall safety of Octaplas in the management of critically ill pediatric patients who require the replacement of multiple coagulation factors.

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Octaplas is a sterile, frozen solution of pooled human plasma that has been treated with a solvent detergent process. It is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease, undergoing cardiac surgery, or liver transplant and for plasma exchange in thrombotic thrombocytopenic purpura (TTP).

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“The results of this study provide clinical evidence supporting the use of Octaplas in critically ill pediatric patients with acquired deficiencies who require replacement of multiple coagulation factors due to liver disease or who are undergoing cardiac or liver transplant surgery,” said Octapharma USA President Flemming Nielsen.

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This article originally appeared on MPR