What is Evicel and how does it work?

Evicel fibrin sealant (human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Evicel is manufactured from pooled human plasma.

What are the side effects of Evicel?

The most common adverse reactions (0.5% of subjects) reported in clinical trials are

The most common additional adverse reactions reported in postmarketing experience are

What is the dosage for Evicel?

  • For topical use only. Do not inject.
  • Apply Evicel to the surface of bleeding tissue only. Do not inject directly into the circulatory system or into tissues.
  • If the hemostatic effect is not complete, apply a second layer.
  • The amount of Evicel required depends upon the area of tissue to be treated and the method of application.
  • As an approximate guide, if a layer of 1 mm thickness is produced by spraying Evicel, the surface areas that can be covered by each of the kit sizes are given in Table 1.

Table 1: Area of Coverage of Each Kit Size

BAC2 Vial SizeThrombin Vial SizePackage SizeArea of Coverage with Layer of 1 mm Thickness
1.0 ml1.0 ml2.0 ml20 cm²
2.0 ml2.0 ml4.0 ml40 cm²
5.0 ml5.0 ml10.0 ml100 cm²

  • Use standard surgical techniques for hemorrhagic control, including suture, ligature and cautery prior to the application of Evicel.
  • Remove excess blood from the site of application to the extent possible using standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
  • Apply Evicel with the approved application device and accessories supplied.
  • Evicel forms a transparent layer on application through which specific bleeding points may be observed; these bleeding points may be sutured or electrocauterized through the layer of Evicel.

What drugs interact with Evicel?

No Information provided

Is Evicelsafe to take when pregnant or breastfeeding?

  • There are no data with Evicel use in pregnant women to inform a drug-associated risk. 
  • It is not known whether Evicel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
  • Evicel should be applied to a pregnant woman only if clearly needed.
  • There is no information regarding the presence of any component of Evicel in human milk, the effect on the breastfed infant, and the effects on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Evicel and any potential adverse effects on the breastfed infant from Evicel or from the underlying maternal condition.

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Medically Reviewed on 10/6/2020
References
FDA Prescribing Information