fibrinogen/thrombin

Action and Spectrum

Actions and Spectrum: 

Actions: 

Fibrinogen and Thrombin are two medications combined to form Fibrinogen + Thrombin. These proteins play a part in the clotting process that occurs naturally. Thrombin functions by breaking down fibrinogen into smaller pieces, or fibrin, which cling to one another and quickly form a blood clot. The clot plugs the wound and aids in halting the bleeding. 

Spectrum: 

Fibrinogen and thrombin, two proteins essential to the blood clotting process, make it possible to produce fibrin, a crucial component in the formation of blood clots. Thrombin has an enzymatic action, converting fibrinogen to fibrin, and it also polymerizes fibrin, activating platelets, coagulation factors, and anticoagulants. It also causes vasoconstriction and regulates fibrinolysis. Fibrinogen is a circulating protein that converts to fibrin activates thrombin, and polymerizes fibrin. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Incision site pain (12%) 

Procedural pain (52%) 

Nausea (26%) 

Constipation (16%) 

1-10% 

Antithrombin antibodies (2%) 

Vomiting (7%) 

Pruritis (6%) 

HTN (5%) 

Pyrexia (8%) 

Anemia (7%) 

Hypotension (7%) 

Black Box Warning

Black Box Warning: 

This drug contains thrombin and fibrinogen. If you have an allergy to fibrinogen/thrombin or any other ingredient in Raplixa, avoid using it. Keep out of children’s reach. If you overdose, obtain medical attention right away or get in touch with a poison control center.

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Intravascular application 
• Human blood products have been linked to serious systemic responses or anaphylaxis 
• severe or rapid bleeding in the arteries 

Cautions 

• result of thromboembolic events after intravascular use 
• hypersensitivity reactions like anaphylaxis, hives, urticaria, chest tightness, hypotension, wheezing 
• risk of infectious agents as these are made from human blood plasma 
• gas or air embolism due to spray devices 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

For mild-to-moderate bleeding in people having surgery, fibrinogen/thrombin is utilized as a supplement to hemostasis when normal surgical procedures (such as sutures, ligatures, and cauteries) are not practical or successful in controlling the bleeding. 

Pharmacodynamics: 

Combination of powders made from human plasma that is intended to replicate the last stages of the coagulation cascade: fibrinogen and thrombin. 

When powder comes into touch with aqueous fluids, such as blood, it dissolves quickly and activates thrombin, which causes fibrinogen to instantly become fibrin and cause a clot to form. 

Pharmacokinetics: 

In the classical meaning, pharmacokinetics describes how medications enter the body and are absorbed, distributed, metabolized, and excreted. However, fibrinogen and thrombin are endogenous molecules involved in the physiological processes of blood clotting and hemostasis, not conventional medications. 

Adminstartion

Administration: 

The processes of hemostasis, or blood clotting, depend on the presence of fibrinogen and thrombin. Fibrinogen and thrombin may be administered as part of therapeutic techniques to treat bleeding issues in certain medical conditions or situations where clotting factors are absent or dysfunctional.   

Only apply to the surface of bleeding tissue; use the RaplixaSpray device or administer straight from the bottle. 

Only for topical usage. 

Avoid reconstituting. 

Use the vial within one hour of opening. 

Able to be applied to several bleeding sites on a single patient. 

Use the RaplixaSpray gadget with no more than two vials. 

Open a fresh device in order to inject a third vial. 

The wound surface needs to be as dry as possible before applying.  

Apply a thin layer of fibrin sealant topically. The product should be administered in an initial quantity that is adequate to cover the entire desired application area. If required, the application can be run again.  

The size of the surface that needs to be covered determines the amount of topical fibrin sealant that is needed.  

To guarantee that the setting fibrin sealant topical securely binds to the surrounding tissue, fix or keep the sealed sections in the correct position for at least three to five minutes after applying both components. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: fibrinogen/thrombin 

Pronounced: FIE-brin-uh-jen/THROM-bin 

Why do we use fibrinogen/thrombin? 

Hemostasis, or blood clotting, is a process in which fibrinogen and thrombin are essential components. As part of therapeutic approaches to address bleeding problems, fibrinogen and thrombin may be given in specific medical illnesses or settings where there is a lack or dysfunction of clotting factors.