FDA Officials OK New Octaplas Product Label
Results of study demonstrate safety profile in pediatric patients.
Officials with the US Food and Drug Administration (FDA) have approved a revised product label for Octaplas, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion (Octapharma USA).
The revisions were based on results of a post-marketing study on Octaplas™ that examined the product’s safety, efficacy and tolerability in treating critically ill pediatric patients who require replacement of multiple coagulation factors.
The prospective, open-label, multicenter, single arm, post-marketing study assessed 50 pediatric patients age 16 years and under (37 neonates/infants, less than age 2 years; and 13 children/adolescents, age 2 to 16 years). Study participants included 40 cardiac surgery patients, 5 liver transplant/dysfunction patients, 4 sepsis-related coagulopathy patients and 1 patient with hypoxic encephalopathy.
Overall safety was assessed by the study researchers as “excellent” for all 50 patients. Hemostatic parameters as measured by international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (aPTT), and thromboelastography (TEG) were within expected ranges following use of Octaplas, according to a press release from the company.
The study results demonstrating the safety of Octaplas™ in the management of critically ill pediatric patients were presented at the Society of Cardiovascular Anesthesiologists Annual Meeting.