Therapy Areas: Cardiovascular
FDA Approves New Octaplas Product Label
24 May 2019 - - The US Food and Drug Administration (FDA) has approved a revised product label for Octapharma USA's Octaplas, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion.

The new labeling provides the results of a post-marketing study on Octaplas that demonstrates 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; and 13 children/adolescents, age 2 to 16).

Study participants included 40 cardiac surgery patients, 5 liver transplant/dysfunction patients, 4 sepsis-related coagulopathy patients and 1 patient with hypoxic encephalopathy.

For complete trial details, visit; clinical trial identifier: NCT02050841.

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 normalised ratio, prothrombin time, activated partial thromboplastin time, and thromboelastography were within expected ranges following use of Octaplas.

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.

Correction of an abnormal coagulation profile is the most common indication for plasma transfusions.

Clinical practice guidelines recommend plasma transfusion in children and neonates with an abnormal coagulation profile and clinically significant bleeding or prior to invasive procedures with a high bleeding risk.

Several types of plasma products are available for transfusion, including fresh frozen plasma or solvent/detergent -treated, pooled plasma.

Octaplas is a S/D treated, virus inactivated, blood group-specific human plasma prepared from pooling multiple single donor FFP units resulting in a standardized composition with significantly lower variability in coagulation factor content compared to standard FFP.

In comparison to FFP, Octaplas is practically cell free, and contains significantly lower residual platelet concentrations and negligible amounts of microparticles due to its manufacturing process.

Octaplas offers a safety benefit as a result of the pathogen inactivation and removal of cells or cell fragments during the manufacturing process.

Octaplas is a solvent/detergent treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura.

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines.

Octapharma employs approximately 8,314 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care.

The company's American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates three production sites licensed by the US Food and Drug Administration (FDA).