Data from FDA - Curated by Toby Galbraith - Last updated 21 June 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

EVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. (1)

Limitations for Use:
• Cannot be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding. (1)
• Not for use in children under one month of age (8.4)
• Laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve.(1)

Full Prescribing information

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Advisory information

contraindications
• Do not use to treat bleeding from large defects in arteries or veins. (4)
• Do not apply intravascularly. (4)
• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. (4)
Special warnings and precautions

• Thrombosis can occur if absorbed systemically. Apply topically to the bleeding site only. (5.1)
• Can cause hypersensitivity reactions including anaphylaxis. (5.2)
• Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur. (5.3)
• EVARREST® contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur. (5.4)
• Avoid use in, around, or in proximity to, foramina in bone or areas of bony confine where swelling may cause compression. (5.5)
• Use the least number of patches required to cover the entire bleeding area. (5.6)
• May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. (5.7)

Adverse reactions

The adverse reactions reported during clinical trials occurred in less than 1% of all cases and included deep venous thrombosis, pulmonary embolism, blood fibrinogen increase, anastomotic hemorrhage, post procedural and intra-abdominal hemorrhage, abdominal distension, anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, localized intra-abdominal fluid collection, cardiac failure, operative hemorrhage, and ischemic bowel. (6)

Usage information

Dosing and administration

For topical use only.
• Determine the number of patches to be applied based upon the surface area and anatomic location of the bleeding tissue to be treated. (2)
• Keep the patch dry until use. (2.1)
• Place the powdery (active) side of the patch on the surface of tissue. (2.2)
• Apply immediate manual compression over the entire surface of the patch and maintain contact pressure for 3 minutes to control the bleeding. (2.2)

Use in special populations
• Pediatric: Use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as recommended. (8.4)

More information

Category Value
Authorisation number BLA125392
Orphan designation No
Product NDC 63713-050
Date First Approved 01-03-2013
Marketing authorisation holder Ethicon, Inc.