New Labeling Reports Results of Post-Marketing Study Demonstrating
Safety, Efficacy and Tolerability in Pediatric Patients
HOBOKEN, N.J.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/CIS?src=hash" target="_blank"gt;#CISlt;/agt;–The U.S.
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 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.”1
Study Details
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,
please visit ClinicalTrials.gov;
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 normalized ratio (INR),
prothrombin time (PT), activated partial thromboplastin time (aPTT), and
thromboelastography (TEG) were within expected ranges following use of
Octaplas™.1
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.
Background
Correction of an abnormal coagulation profile is the most common
indication for plasma transfusions.2 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.3
Several types of plasma products are available for transfusion,
including fresh frozen plasma (FFP) or solvent/detergent (S/D)-treated,
pooled plasma.4 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.5 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.6 Octaplas™ offers a safety benefit
as a result of the pathogen inactivation and removal of cells or cell
fragments during the manufacturing process.
About Octaplas™
Octaplas™
is a solvent/detergent (S/D) 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 (TTP).
WARNINGS AND PRECAUTIONS
Transfusion reactions can occur with ABO blood group mismatches; high
infusion rates can induce hypervolemia with consequent pulmonary edema
or heart failure; excessive bleeding due to hyperfibrinolysis can occur
due to low levels of alpha 2-antiplasmin; thrombosis can occur due to
low levels of Protein S; citrate toxicity can occur with volumes
exceeding one milliliter of Octaplas™ per kg per minute; Octaplas™ is
made from human blood and may carry the risk of transmitting infectious
agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob
disease and Creutzfeldt-Jakob disease agent.
Please see full prescribing information at www.octaplasus.com.
About the Octapharma Group
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
state-of-the-art production sites licensed by the U.S.
Food and Drug Administration (FDA), providing a high level of
production flexibility. For more information, please visit www.octapharmausa.com.
REFERENCES
1. Data on file, Octapharma USA, 2019.
2. Labarinas, S., Arni, D.,
Karam, O.: Plasma in the PICU. Annals of Intensive Care. 3, 16 (2013).
3.
New, H. V., Berryman, J., Bolton-Maggs, et al.: Guidelines on
transfusion for fetuses, neonates and older children. Br. J. Haematol.
175, 784–828 (2016).
4. Camazine, M. N., Karam, O., Colvin, R., et
al.: Outcomes Related to the Use of Frozen Plasma or Pooled
Solvent/Detergent-Treated Plasma in Critically Ill Children. Pediatric
critical care medicine a journal of the Society of Critical Care
Medicine and the World Federation of Pediatric Intensive and Critical
Care Societies. 18, e215-e223 (2017).
5. Heger, A., Romisch, J.,
Svae, T.-E.: A biochemical comparison of a pharmaceutically licensed
coagulation active plasma (Octaplas) with a universally applicable
development product (Uniplas) and single-donor FFPs subjected to
methylene-blue dye and white-light treatment. Transfus. Apher. Sci. 35,
223–233 (2006).
6. Spinella, P. C., Frazier, E., Pidcoke, et al.:
All plasma products are not created equal. J. Trauma Acute Care Surg.
78, S18-25 (2015).
OPLAS-0124
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Public Relations
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