Highly Purified Fibrinogen Concentrate1
Fibryga is a highly purified, virus-inactivated and nanofiltered (20 nm) human plasma-derived, fibrinogen concentrate1,2
- Sterile, freeze-dried preparation of highly purified fibrinogen2
- Prepared from large pools of human plasma screened via serologic and nucleic acid tests2
- Undergoes 2-step process for viral inactivation (solvent/detergent) and removal (nanofiltration)1
- Similar pharmacokinetic (PK) profile compared to active control3
- Achieved successful efficacy outcome in 99% of bleeding events2,9
How supplied
Fibryga is supplied as a lyophilized powder for reconstitution for intravenous injection. Fibryga contains no preservatives. Each bottle contains approximately 1g of fibrinogen. The diluent for reconstitution of
the lyophilized powder is sterile Water for Injection.
The nominal composition of fibryga is as follows:2
| Component | Quantity/mL |
|---|---|
| Human Fibrinogen | 20 mg |
| Sodium Chloride | 6 mg |
| Sodium Citrate Dihydrate | 1.5 mg |
| Glycine | 10 mg |
| L-Arginine Hydrochloride | 10 mg |
- Fibryga is a purified fibrinogen preparation as demonstrated by a high specific activity of approximately 98% clottable protein based on total protein1,2
- The high purity and activity are supported further by the ratio of fibrinogen antigen to clottable protein, which is almost identical to the theoretical value of 1.0 for a fully native fibrinogen preparation1
- The fibryga preparation contains approximately 200 IU FXIII/g of fibrinogen, which is essential for cross-linking of fibrin strands and stable clot formation1
- Low levels of activation marker proteins and high molecular weight proteins are present (see Table)
| Biochemical Characterization of Fibryga1 | |
|---|---|
| Parameter | fibryga (N=6) Mean ± SD |
| Fibrinogen Activity |
|
| Specific Activity Clottable Protein/Total Protein (%) | 98 ± 7 |
| Fibrinogen Clauss/Clottable Protein (mg/mg) | 1.08 ± 0.09 |
| Fibrinogen Antigen/Clottable Protein (mg/mg) | 1.05 ± 0.09 |
| Activation And Fibrinolysis Marker Proteins | |
| Fibrinopeptide A (ng/mg) | 0.3 ± 0.1 |
| D-dimer (ng/mg) | 3.7 ± 0.9 |
| Plasminogen (mU/mg) | 1.8 ± 0.3 |
| Accompanying Proteins | |
| FXIII Activity (IU/mg) | 0.20 ± 0.01 |
| Fibronectin (μg/mg) | 0.8 ± 0.3 |
| Albumin (mg/mg) | 0.02 ± 0.01 |
| von Willebrand Factor (IU/mg) | 0.01 ± 0.002 |
| Vitronectin (ng/mg) | < 0.001 |
| Size Distribution (SEC) | |
| HMW Proteins (%)a | 2.8 ± 0.5 |
aExpressed as percentage of the total chromatogram area.
For standardization, ratios of respective parameters versus clottable protein are shown.
FXIII = factor XIII; HMW = high molecular weight; SEC = size exclusion chromatography.
Source: Schulz PM, Gehringer W, Nöhring S, et al. Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (Fibryga). Biologicals. 2018;52:72-77.
Fibrinogen concentrate is the preferred choice for fibrinogen replacement in CFD4, offering a broad range of advantages over cryoprecipitate and fresh frozen plasma, including viral safety and convenience1,5-8
References:
- Schulz PM, Gehringer W, Nöhring S et al. Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (Fibryga). Biologicals . 2018; 52:72-77.
- Fibryga full Prescribing Information. Paramus, NJ: Octapharma; rev 2020.
- Ross C, Rangarajan S, Karimi M, et al. Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency. J Thromb Haemost. 2018;16:253-261.
- Lissitchkov T, Madan B, Djambas Khayat C, et al. Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of a Phase III trial. Transfusion. 2018;58(2):413-42.
- Tziomalos K, Vakalopoulou S, Perifanis V, et al. Treatment of congenital fibrinogen deficiency: overview and recent findings. Vasc Health Risk Manag. 2009; 5:843–848.
- Casini A, de Moerloose P, Neerman- Arbez M. Clinical features and management of congenital fibrinogen deficiencies. Semin Thromb Hemost. 2016;42:366–374.
- Franchini M, Lippi G. Fibrinogen replacementtherapy: a critical review of the literature. Blood Transfus. 2012;10:23–27.
- Levy JH, Welsby I, Goodnough LT. Fibrinogen as a therapeutic target for bleeding: a review of critical levels and replacement therapy. Transfusion. 2014;54:1389–1405.
- Lissitchkov T, Madan B, Djambas Khayat C, et al. Fibrinogen concentrate for treatment of bleeding and surgical prophylaxis in congenital fibrinogen deficiency patients. J Thromb Haemost. 2020;18(4):815-824