FDA Approves Octaplas to Treat Pediatric Patients Who Require Multiple Coagulation Factor Replacement

A revised product label for Octapharma USA’s Octaplas (pooled plasma [human] solvent/detergent treated solution for intravenous infusion) to treat critically ill pediatric patients who require replacement of multiple coagulation factors has been approved by the U.S. Food and Drug Administration (FDA). Approval was based on a prospective, open-label, multicenter, single arm, post-marketing study that assessed 50 pediatric patients age 16 years and younger (37 neonates/infants less than 2 years; and 13 children/adolescents age 2 years to 16 years). Study participants included 40 cardiac surgery patients, five liver transplant/dysfunction patients, four sepsis-related coagulopathy patients and one patient with hypoxic encephalopathy. Patients were dosed based on body weight, and doses were adjusted as needed. There were no hyperfibrinolytic or treatment-related thromboembolic events reported by investigators. Overall safety was assessed by investigators as “excellent” for all 50 patients. Hemostatic parameters as measured by international normalized ratio, prothrombin time, activated partial thromboplastin time and thromboelastography were within expected ranges following use of Octaplas.

“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. “The results of the present study and those of previous studies comparing Octaplas with fresh frozen plasma support its use in this patient population.”