Grifols, as announced in a recent press release, has officially launched FESILTY™ (fibrinogen, human-chmt) in the United States. The therapy is approved to treat sudden, severe bleeding in adults and children with congenital fibrinogen deficiency (CFD), a rare genetic disorder that prevents the body from clotting blood properly.
Key Benefits of FESILTY
Unlike traditional treatments like plasma or cryoprecipitate, which require large infusion volumes and lengthy preparation times, FESILTY offers a faster, more targeted approach:
- Fast Preparation: The complete kit can be mixed and ready to use in about three minutes.
- Convenient Storage: It can be kept at room temperature right where care is delivered.
- Precise Dosing: It delivers a specific, highly purified amount of fibrinogen without needing blood-type matching.
“FESILTY gives doctors a reliable, fast-acting tool to control dangerous bleeding episodes when every minute matters,” said Roland Wandeler, President of Grifols Biopharma.
Clinical Background
The U.S. Food and Drug Administration (FDA) approved FESILTY based on a clinical trial evaluating its safety and effectiveness. Recent studies published in medical journals (Thrombosis and Haemostasis and Thrombosis Research) confirmed that the treatment safely and effectively stops acute bleeding in both adult and pediatric patients.
Important Safety Information
- Usage: FESILTY is only for patients with congenital fibrinogen deficiency (specifically hypo- or afibrinogenemia). It is not for individuals with dysfibrinogenemia.
- Side Effects: The most common side effects include limb and back pain, fever, headache, and vomiting.
- Risks: Severe allergic reactions can occur. Because it aids clotting, there is a risk of dangerous blood clots (thrombosis). Additionally, because it is made from human blood plasma, a risk of transmitting infectious diseases remains.
For full prescribing details, please review the complete FESILTY medical information.
