The Food and Drug Administration (FDA) has approved updated labeling for Octaplas Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion and fibryga® (fibrinogen [human]) to include data on pediatric use.

Octaplas is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or in those undergoing cardiac surgery or liver transplantation. It is also indicated for plasma exchange in thrombotic thrombocytopenic purpura.

The updated labeling for Octaplas includes data from 2 post-marketing studies (LAS-212 [ClinicalTrials.gov: NCT02050841], LAS-213 [ClinicalTrials.gov: NCT01938378]) that assessed the efficacy, safety and tolerability in pediatric patients. The LAS-212 study evaluated Octaplas in 50 pediatric patients 16 years of age and under and included 40 cardiac surgery patients, 5 liver transplant/dysfunction patients, 4 patients with sepsis-related coagulopathy, and 1 patient with hypoxic encephalopathy. Investigators determined that the overall safety of Octaplas was “excellent” (using prespecified definitions of excellent, good or poor) for all patients.

In the LAS-213 study, Octaplas was evaluated in a total of 102 therapeutic plasma exchange (TPE) procedures in 41 patients 2 to 20 years of age. Study participants included those with immune system disorders (n=14), nervous system disorders (n=12), renal and urinary disorders (n=8), infections and infestations (n=4), and other disorders (n=3). No treatment-related serious adverse events were reported in the study. Among these patients, there were a total of 8 adverse reactions in 4 patients; these were mostly mild in intensity and resolved by the end of the study. Overall safety was determined to be “excellent” by investigators in greater than 90% of patients at 24 hours after each TPE.


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Octaplas is supplied as a solution for infusion containing 45 to 70mg human plasma protein per mL in a 200mL volume.

The FDA has also expanded the approval of fibryga to include patients less than 12 years of age with congenital fibrinogen deficiency (CFD) for on-demand treatment of acute bleeding episodes. The approval is supported by data from a prospective, open-label phase 3 study (ClinicalTrials.gov: NCT02408484) that evaluated the efficacy, pharmacokinetics and safety of fibryga in 14 pediatric patients with CFD (median age: 6 years). 

The Food and Drug Administration (FDA) has approved updated labeling for Octaplas Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion and fibryga® (fibrinogen [human]) to include data on pediatric use.

Octaplas is indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or in those undergoing cardiac surgery or liver transplantation. It is also indicated for plasma exchange in thrombotic thrombocytopenic purpura.

The updated labeling for Octaplas includes data from 2 post-marketing studies (LAS-212 [ClinicalTrials.gov: NCT02050841], LAS-213 [ClinicalTrials.gov: NCT01938378]) that assessed the efficacy, safety and tolerability in pediatric patients. The LAS-212 study evaluated Octaplas in 50 pediatric patients 16 years of age and under and included 40 cardiac surgery patients, 5 liver transplant/dysfunction patients, 4 patients with sepsis-related coagulopathy, and 1 patient with hypoxic encephalopathy. Investigators determined that the overall safety of Octaplas was “excellent” (using prespecified definitions of excellent, good or poor) for all patients.

In the LAS-213 study, Octaplas was evaluated in a total of 102 therapeutic plasma exchange (TPE) procedures in 41 patients 2 to 20 years of age. Study participants included those with immune system disorders (n=14), nervous system disorders (n=12), renal and urinary disorders (n=8), infections and infestations (n=4), and other disorders (n=3). No treatment-related serious adverse events were reported in the study. Among these patients, there were a total of 8 adverse reactions in 4 patients; these were mostly mild in intensity and resolved by the end of the study. Overall safety was determined to be “excellent” by investigators in greater than 90% of patients at 24 hours after each TPE.

Octaplas is supplied as a solution for infusion containing 45 to 70mg human plasma protein per mL in a 200mL volume.

The FDA has also expanded the approval of fibryga to include patients less than 12 years of age with congenital fibrinogen deficiency (CFD) for on-demand treatment of acute bleeding episodes. The approval is supported by data from a prospective, open-label phase 3 study (ClinicalTrials.gov: NCT02408484) that evaluated the efficacy, pharmacokinetics and safety of fibryga in 14 pediatric patients with CFD (median age: 6 years). 

Reference

FDA approvals strengthen Octapharma USA pediatric critical care product portfolio. [press release]. Paramus, NJ: Octapharma USA, Inc.; March 29, 2021.