Fibrinogen human

Generic Name: Fibrinogen human

Brand Names: Artiss, Evarrest, Evicel, Fibryga, Riastap, Tachosil, Tisseel, Vistaseal

Drug Type: Biotech

Chemical Formula: -

CAS Number: 9001-32-5

Unique Ingredient Identifier: N94833051K

Background: Fibrinogen concentrate (human) is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. It is a physiological substrate for three enzymes: plasmin, factor XIIIa and thrombin. It is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Indication: Human fibrinogen is used for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

In combination with thrombin, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

Associated Conditions: Bleeding, Dura Mater Nick Cut or Tear, Surgical Bleeding, Acute bleeding episodes

Associated Therapies: Tissue Adhesions, Maintenance of surgical hemostasis therapy

Clinical Trials

Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients With its Fibrin Sealant

Grifols' plasma-protein based fibrin sealant (FS) received FDA approval for pediatric patients in the U.S., extending its availability from Europe and adults. FS, marketed as VISTASEAL™ in the U.S. and Canada, and VERASEAL™ in Europe, promotes hemostasis and tissue sealing during surgery, reducing blood loss and complications. The FS solution is now available in 18 countries and combines fibrinogen and thrombin with Johnson & Johnson MedTech’s airless spray technology.

contemporarypediatrics.com

2 months ago

FDA approves fibrin sealant to control surgical bleeding in pediatric patients

FDA approves Grifols' VISTASEAL fibrin sealant for surgical bleeding control in pediatric patients, achieving 95% efficacy and rapid hemostasis within 4 minutes, with comparable safety profiles to active control.

drugs.com

2 months ago

Blood Test Might Spot Women in Labor at Risk for Preeclampsia

A blood test can identify women in labor at risk for preeclampsia by analyzing fibrinogen and albumin levels, with a higher fibrinogen-to-albumin ratio (FAR) indicating increased risk. FAR of 0.1 correlates with a 24% risk, while FAR above 0.3 indicates over 41% risk. This method could aid in early identification and preventive measures.

bmcgastroenterol.biomedcentral.com

3 months ago

Predictive model for identification of gangrenous or perforated appendicitis in adults

A novel scoring model for gangrenous appendicitis (GPA) in adults was developed using clinical characteristics, lab tests, and abdominal CT results. Seven independent predictors were identified: WBC, lymphocyte, D-dimer, glucose, and albumin levels, plus appendix diameter and fecalith presence. The model demonstrated strong diagnostic accuracy for predicting gangrenous and perforated appendicitis, validated across different populations, and aims to guide treatment decisions, particularly exploring non-surgical options.

empr.com

3 months ago

August 2024: Notable Drug Approvals

FDA approvals include Neffy (epinephrine nasal spray for anaphylaxis), Nemluvio (nemolizumab-ilto for prurigo nodularis), NexoBrid (anacaulase-bcdb for pediatric burn eschar removal), Otezla (apremilast for pediatric plaque psoriasis), Yorvipath (palopegteriparatide for hypoparathyroidism), Livdelzi (seladelpar for primary biliary cholangitis), Fibryga (fibrinogen for acquired deficiency), Niktimvo (axatilimab-csfr for chronic graft-vs-host disease), ACAM2000 (smallpox and mpox vaccine), Crexont (carbidopa and levodopa for Parkinson disease), Imfinzi (durvalumab for resectable NSCLC), Lazcluze (lazertinib with Rybrevant for EGFR-mutated NSCLC), Lymphir (denileukin diftitox-cxdl for cutaneous T-cell lymphoma), Tecelra (afamitresgene autoleucel for synovial sarcoma), Voranigo (vorasidenib for IDH-mutant glioma), Enzeevu (aflibercept-abzv for wet AMD), and Zurnai (nalmefene HCI for opioid overdose).

Drug Development Updates

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