Evicel

What is Evicel?

Evicel is a medicine used as a sealant (glue) and consists of two solutions: one contains the active ingredient fibrinogen (50 to 90 mg / ml) and the other contains the active ingredient thrombin (800 to 1200 international units per milliliter) .

What is Evicel used for?

Evicel is used by the surgeon to reduce localized bleeding during surgery when standard techniques are not sufficient. Evicel can also be used as an adjunct to suturing in vascular surgery (blood vessel surgery).
The medicine can only be obtained with a prescription.

How is Evicel used?

Evicel should only be used by an experienced surgeon. Before use, the two Evicel solutions must be mixed together using a special mixer supplied with the medicine. Evicel is then applied drop by drop or sprayed on the wound surface to form a thin layer. The amount of Evicel to use depends on a range of factors, including type of surgery, wound size and number of applications.
The use of Evicel is not recommended in children as data on the safety and efficacy of the medicine in this age group are largely insufficient.

How does Evicel work?

The active ingredients contained in Evicel (fibrinogen and thrombin) are natural substances obtained from human plasma (the liquid part of the blood). When the two active ingredients are mixed together, thrombin breaks down fibrinogen into smaller units, fibrins. These aggregate (adhere) to each other and form a fibrin clot that promotes wound healing, stopping bleeding.

How has Evicel been studied?

The effects of Evicel were first tested in experimental models before being studied in humans. As the thrombin solution contained in Evicel is also used in another medicine, Quixil, which is already authorized in 14 European countries, the company used some data from Quixil to support the use of Evicel. Evicel's effectiveness was investigated. of two main studies involving a total of 282 patients. The first study compared the effectiveness of Evicel versus manual compression (pressure applied directly with the hand) in reducing bleeding during vascular surgery. The main measure of effectiveness was the number of patients without bleeding (haemostasis) at the site. of application after four minutes from the application of Evicel or from the compression carried out with the hand.
The second study compared the effectiveness of Evicel versus Surgicel (a material used to help stop bleeding) in reducing bleeding during abdominal surgery (operations performed on the organs of the belly). The main measure of effectiveness was the number of patients without bleeding at the application site 10 minutes after application of Evicel or Surgicel.

What benefit has Evicel shown during the studies?

Evicel was more effective than comparator treatments in reducing bleeding at the application site. In vascular surgery, 85% of patients no longer bleed after four minutes of treatment with Evicel (64 out of 75) compared to 39% of patients treated with manual compression (28 out of 72). In cases of abdominal surgery, 95% of patients no longer bleed 10 minutes after Evicel treatment (63 out of 66) compared to 81% of patients treated with Surgicel (56 out of 69).

What is the risk associated with Evicel?

Like other sealants, Evicel can also induce allergic reactions. In rare cases the patient may also develop antibodies directed against the proteins contained in Evicel with possible interference in the clot formation process. Accidental application of Evicel into a blood vessel can cause thromboembolic complications (clot formation). For the full list of side effects reported with Evicel, see the package leaflet.
Evicel should not be used in patients who may be hypersensitive (allergic) to fibrinogen, thrombin or any of the other ingredients and should not be injected into blood vessels.

Why has Evicel been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Evicel's benefits are greater than its risks when used as supportive treatment in surgery to improve haemostasis in cases where standard techniques are insufficient and as support for suturing. to obtain hemostasis in vascular interventions. The committee recommended the granting of marketing authorization for Evicel.

Other information about Evicel:

On 6 October 2008 the European Commission released to Omrix Biopharmaceuticals S.A. a "marketing authorization" for Evicel, valid throughout the European Union.
For the full version of Evicel's EPAR click here.

Last update of this summary: 08-2008.

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