FOR ACUTE BLEEDING EPISODES IN PATIENTS WITH CFD
WHEN EVERY MINUTE COUNTS, COUNT ON FESILTY
RAPID FIBRINOGEN SUPPLEMENTATION AT KEY STAGES WITH FESILTY2
Clinical Trial Part 1
CLINICAL TRIAL SUPPORTS USING FESILTY IN PATIENTS WITH CFD2
A prospective, open-label, multinational, multicenter, phase I/III study2
Objective:
Investigate the 14-day, single-dose, pharmacokinetics/pharmacodynamics (PK/PD) properties, surrogate efficacy, and safety of FESILTY following intravenous administration in patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.2
STUDY DESIGN
Multinational, multicenter study in 6 sites2
Study Population
27 patients (15 adults, 12 pediatric) with congenital afibrinogenemia or severe hypofibrinogenemia2
Dosing
Single intravenous dose of FESILTY (human fibrinogen concentrate) at 70 mg/kg body weight2
Primary Endpoint
14-day pharmacokinetics of FESILTY2
Secondary Endpoints
Pharmacodynamics, surrogate efficacy (clot firmness), and safety over 49 days2
CLINICAL TRIAL SHOWS FESILTY PROVIDES RAPID AND EFFECTIVE RESULTS2
Data show that FESILTY effectively increased FiAg and FiAc while restoring clot formation2
FiAc, fibrinogen activity; FiAg, fibrinogen concentration; FIBTEM, fibrin-based extrinsically activated thromboelastometry.
Clinical Trial Part 2
CLINICAL TRIAL DEMONSTRATES RELIABLE CONTROL FOR TREATMENT OF BLEEDING EPISODES IN PATIENTS WITH CFD5
A prospective, open-label, multinational, multicenter, phase I/III study5
Objective:
Assess the clinical efficacy and safety of FESILTY after patients received a single or repeated IV infusion(s) for on-demand prophylaxis (ODP) or on-demand treatment (ODT) of bleeding events, including surgery and spontaneous or posttraumatic bleeding.5,6
STUDY DESIGN
Multinational, multicenter study in 6 sites6
Study Population
36 patients (20 adults, 16 pediatric) with congenital afibrinogenemia or severe hypofibrinogenemia5
Dosing
Single or repeated intravenous dose of FESILTY (human fibrinogen concentrate) as required based on individual body weight and fibrinogen level6
Primary Endpoint
Overall hemostatic response5*
*Response to all bleedings was evaluated by the investigator according to a 4-point scale: “none”, “moderate”, “good”, or “excellent” at the end of the bleeding event or at hospital discharge for ODT or ODP.
RELIABLE HEMOSTATIC CONTROL DURING BLEEDING EVENTS5
Data show FESILTY demonstrated “excellent” results in overall hemostatic control during bleeding events.5*
*Response to all bleedings was evaluated by the investigator according to a 4-point scale: “none”, “moderate”, “good”, or “excellent” at the end of the bleeding event or at hospital discharge for ODT or ODP.
FESILTY is well tolerated in both pediatric and adult patients1
*Hypersensitivity reactions=all patients had adverse reactions of facial swelling.
†Thrombosis includes portal vein thrombosis and deep vein thrombosis.
FIND OUT MORE ABOUT FESILTY
Learn more about how to dose, reconstitute, and administer FESILTY
Find helpful information about FESILTY
IMPORTANT SAFETY INFORMATION
View CloseIndications and Usage
FESILTY (fibrinogen, human-chmt) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.
Limitations of Use:
FESILTY is not indicated for dysfibrinogenemia.
Contraindications
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate).
Warnings and Precautions
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment.
Thrombotic events have occurred in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis.
FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse Reactions
The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of FESILTY.
In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving FESILTY were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
Please see full Prescribing Information for FESILTY.
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indications and Usage
FESILTY (fibrinogen, human-chmt) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.
Limitations of Use:
FESILTY is not indicated for dysfibrinogenemia.
Contraindications
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate).
Warnings and Precautions
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment.
Thrombotic events have occurred in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis.
FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse Reactions
The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of FESILTY.
In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving FESILTY were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
Please see full Prescribing Information for FESILTY.
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
IMPORTANT SAFETY INFORMATION
Indications and Usage
FESILTY (fibrinogen, human-chmt) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.
Limitations of Use:
FESILTY is not indicated for dysfibrinogenemia.
Contraindications
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate).
Warnings and Precautions
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment.
Thrombotic events have occurred in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis.
FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Adverse Reactions
The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of FESILTY.
In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving FESILTY were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
Please see full Prescribing Information for FESILTY.
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
References
- FESILTY [package insert]. Grifols, S.A.
- Khayat CD, El-Beshlawy A, Meddeb B, Khelif A, Miesbach W, Adolf S, Hoehm H, Aigner S, Abraha S, Bohlaender F, Schuettrumpf J. Pharmacokinetics, hemostatic efficacy, and safety of a new human fibrinogen concentrate in adult and pediatric patients with congenital fibrinogen deficiency. Thromb Haemost. Published online October 17, 2025. doi:10.1055/a-2715-2994
- FIBRYGA [package insert]. Octapharma USA, Inc.
- RiaSTAP. Summary of Product Characteristics. CSL Berhing.
- Khayat CD, El-Beshlawy A, Omar N, et al. Efficacy and safety of prophylaxis and treatment of bleeding events with a novel fibrinogen concentrate from human plasma in patients with congenital fibrinogen deficiency. Throm Res. Published online February 10, 2026. doi:10.1016/j.thromres.2026.109616.
- ClinicalTrials.gov. Study of BT524 (Part II) in congenital fibrinogen deficiency. Updated July 3, 2025. Accessed January 12, 2026. https://clinicaltrials.gov/study/NCT02065882. ClinicalTrials.gov Identifier: NCT02065882.