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fibryga®, the smart move to control bleeding
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fibryga® is a lyophilized fibrinogen concentrate of high purity, protein quality and pathogen safety, produced from pooled human plasma.1
The high purity
is indicated by:1
the 98% clottable protein, the ratio of fibrinogen antigen to clottable protein that is almost identical to the theoretical value of 1.0 for a fully native fibrinogen
the low content of high molecular weight (HMW) proteins.
The functionality is carefully preserved through a precise manufacturing process, reflected in:
its low levels of activation markers.1
a reliable clot formation, evidenced by a significant increase in maximum clot firmness in thromboelastometry.2
The FXIII content
facilitates adequate crosslinking, contributing to stable clot formation, as demonstrated in vitro.1
Pathogen safety is ensured through a double inactivation/elimination steps:1
solvent-detergent treatment (TnBP and Octoxynol) to inactivate enveloped viruses
20 nm nanofiltration, which removes both enveloped and non-enveloped viruses, including HAV, along with prions and porcine parvovirus (PPV).
fibryga® is indicated for
Congenital fibrinogen deficiency
(CFD)3
Treatment of bleeding and peri-operative prophylaxis in patients with congenital hypo- or afibrinogenaemia with bleeding tendency.
Acquired fibrinogen deficiency
(AFD)3
As complementary therapy in the management of uncontrolled severe haemorrhage in patients with acquired hypofibrinogenaemia in the course of surgical intervention.
fibryga® ensures
haemostatic efficacy
Proven 100% success
on haemostatic efficacy in AFD4
Based on overall haemostatic efficacy (n=21)
Faster access time4
Compared to Cryoprecipitate, the initial infusion began 24 minutes earlier.
Good tolerability5
Offering the potential for fewer thromboembolic events (7.0%) compared to cryoprecipitate (9.6%) (OR 0.70, 95% CI: 0.42-1.20).
Fast reconstitution for earlier patient intervention¹⋅³
:quality(80))
References
Schulz PM, Gehringer W, Nöhring S, Müller S, Schmidt T, Kekeiss-Schertler S, Solomon C, Pock K, Römisch J. Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga®). Biologicals. 2018 Mar;52:72-77. doi: 10.1016/j.biologicals.2017.12.003. Epub 2018 Jan 12. PMID: 29336864. [PubMed]
Ross C, Rangarajan S, Karimi M, Toogeh G, Apte S, Lissitchkov T, Acharya S, Manco-Johnson MJ, Srivastava A, Brand B, Schwartz BA, Knaub S, Peyvandi F. Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency. J Thromb Haemost. 2018 Feb;16(2):253-261. doi: 10.1111/jth.13923. Epub 2018 Jan 22. PMID: 29220876. [PubMed]
fibryga Summary of Product Characteristics
Roy A, Stanford S, Nunn S, Alves S, Sargant N, Rangarajan S, Smith EA, Bell J, Dayal S, Cecil T, Tzivanakis A, Kruzhkova I, Solomon C, Knaub S, Moran B, Mohamed F. Efficacy of fibrinogen concentrate in major abdominal surgery - A prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei. J Thromb Haemost. 2020 Feb;18(2):352-363. doi: 10.1111/jth.14665. Epub 2019 Nov 26. PMID: 31654548; PMCID: PMC7027898. [PubMed]
Callum J, Farkouh ME, Scales DC, Heddle NM, Crowther M, Rao V, Hucke HP, Carroll J, Grewal D, Brar S, Bussières J, Grocott H, Harle C, Pavenski K, Rochon A, Saha T, Shepherd L, Syed S, Tran D, Wong D, Zeller M, Karkouti K; FIBRES Research Group. Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial. JAMA. 2019 Nov 26;322(20):1966-1976. doi: 10.1001/jama.2019.17312. PMID: 31634905; PMCID: PMC6822637. [PubMed]
