Efficacy and Safety of Octaplas for Pediatric Patients

Effects of octaplas in the management of pediatric patients who require replacement of multiple coagulation factors1,2

  • Open-label, multicenter, phase 4 (post-marketing) study conducted in 50 enrolled patients <16 years old who required replacement of multiple coagulation factors due to liver dysfunction associated with coagulopathy (n = 5, 10%) and/or required cardiac surgery (n = 40, 80%) or liver transplant surgery (n = 5, 10%)
  • All 50 patients had ≥1 infusion episode, ten had 2 infusion episodes, five had 3 infusion episodes and one had 6 infusion episodes of octaplas administered intravenously based on ABO-group compatibility
  • Primary endpoints: incidence of serious adverse events (SAEs), adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and hyperfibrinolytic events (HFEs)
STUDY OBJECTIVES: ASSESS EFFICACY, SAFETY, AND TOLERABILITY OF OCTAPLAS IN PEDIATRIC PATIENTS REQUIRING REPLACEMENT OF MULTIPLE COAGULATION FACTORS
Occurrence of any SAE2 Total Population
(n = 50)
Infants ≤ 2 years
(n = 37)
Children > 2 years
(n = 13)
SAEs n Patients n (%) SAEs n Patients n (%) SAEs n Patients n (%)
9 5 (10%) 3 3 (8.1%) 6 2 (15.4%)

Conclusions

  • For all 50 patients, investigator assessment of safety was “excellent”
  • No ADRs, HFEs or treatment-related TEs or TEEs occurred during the study
  • No SAEs that occurred were considered to be related to octaplas
  • Treatment response appeared favorable in the majority of patients

Effects of octaplas in the management of pediatric patients who require therapeutic plasma exchange1,3

  • Open-label, multicenter, phase 4 (post-marketing) study conducted in 41 enrolled patients 2 to 20 years old in whom therapeutic plasma exchange (TPE) was required
  • Each subject underwent between 1 and 6 TPEs (mean: 2.5 TPEs). Timeframe: up to 8 days including the 24-hour follow-up from treatment
  • Primary endpoints: incidence of serious adverse events (SAEs), adverse drug reactions (ADRs), thrombotic events (TEs), and thromboembolic events (TEEs)
STUDY OBJECTIVES: ASSESS EFFICACY, SAFETY, AND TOLERABILITY OF OCTAPLAS IN PEDIATRIC PATIENTS REQUIRING THERAPEUTIC PLASMA EXCHANGE
Adverse Drug Reactions (ADRs) Reported in 4 of the 41 (9.8%) Total Patient Population
Occurrence of ADR Total Population
(n = 41)
Children
Age 2 – <12
(n = 15)
Adolescents
Age 12 – <17
(n = 13)
Young Adults
Age >17
(n = 13)
ADRs n Patients n (%) ADRs n Patients n (%) ADRs n Patients n (%) ADRs n Patients n (%)
8 4
(9.8%)
0 0
(0%)
5 3
(30.76%)
3 1
(23.8%)

Conclusions

  • Overall safety was assessed by investigators as excellent for most subjects (>90%)
  • No treatment-related SAEs were reported
  • No TEs or TEEs were reported
  • ADRs reported in 4 of 41 subjects; most adverse reactions (7/8) were mild in intensity and resolved by end of study
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Available in 200 mL bags in A, B, O and AB blood groups

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Reference:
  1. Octaplas Full Prescribing Information. Paramus, NJ: Octapharma; rev 2021.
  2. Spinella, P.C., Borasino, S., and Alten, J., “Solvent/Detergent-Treated Plasma in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors: An Open-Label, Multicenter, Post-marketing Study”, Frontiers in Pediatrics. 2020;8:572.
  3. Josephson, C.D. et al., “Safety and tolerability of solvent/detergent-treated plasma for pediatric patients requiring therapeutic plasma exchange: An open-label, multicenter, postmarketing study”, Transfusion. 2022;62:396-405.