Evarrest

What is Evarrest

• Evarrest (fibrinogen human and human thrombin patch) is used with manual compression as an adjunct to hemostasis.

What are the uses of this medicine?

• 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.

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.
• Not for use in children under one month of age
• Laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve.

How does this medicine work?

• The mechanism of action of EVARREST is based on the interaction between the biological components and the physiology of the fibrin clot formation.
• Upon contact with a bleeding wound surface, the biological components embedded in the patch component are hydrated, and the subsequent fibrinogen-thrombin reaction initiates the last step in the cascade of biochemical reactions - conversion of fibrinogen into fibrin monomers that further polymerize to form the fibrin clot.
• Hemostasis is achieved when the formed fibrin clot integrates with the patch component and adheres to the wound surface thus also providing a physical barrier to bleeding.

Who Should Not Use this medicine ?

This medicine cannot be used for:

• Bleeding from large defects in visible arteries or veins.
• Intravascular application
• Individuals known to have anaphylactic or severe systemic reaction to human blood products

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with EVARREST.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• Determine the number of patches to be applied based upon the surface area and anatomic location of the bleeding to be treated.
• Do not use more than eight 2 × 4 inch (5.1 × 10.2 cm) patches.

Administration:

• Keep the patch dry until use.
• Place the powdery (active) side of the patch on the surface of tissue.
• Apply immediate manual compression over the entire surface of the patch and maintain contact pressure for 3 minutes to control the bleeding.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 2 × 4 inch (5.1 × 10.2 cm) absorbable patch contains
• 55.5 mg per square inch (8.6 mg per square cm) human fibrinogen
• 241.9 Units per square inch (37.5 Units per square cm) human thrombin

This medicine is available in fallowing brand namesː

• EVARREST

What side effects can this medication cause?

The most common side effects of this medicine include:

• 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
• ischemic bowel

What special precautions should I follow?

• Thrombosis can occur if absorbed systemically. Apply topically to the bleeding site only.
• EVARREST Can cause hypersensitivity reactions including anaphylaxis.
• Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur.
• EVARREST® contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur.
• Avoid use in, around, or in proximity to, foramina in bone or areas of bony confine where swelling may cause compression.
• Use the least number of patches required to cover the entire bleeding area.
• Because the biological components of this product are made from human plasma, it 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no data with EVARREST® use in pregnant women to inform a drug-associated risk.
• It is not known whether EVARREST can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• EVARREST should be applied to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• Fibrinogen Human
• Human Thrombin

Inactive ingredients:

• Arginine hydrochloride
• Calcium chloride
• Glycine
• Albumin Human
• Mannitol
• Sodium acetate
• Sodium chloride
• Sodium citrate, unspecified form

Who manufactures and distributes this medicine?

Distributed by: Ethicon, Inc. Route 22 West, PO Box 151 Somerville, NJ USA

Manufactured by: Omrix Biopharmaceuticals Ltd. 14 Einstein Street Weizmann Science Park Nes-Ziona, Israel

What should I know about storage and disposal of this medication?

• Use EVARREST before the expiration date indicated on the carton.
• Store unopened packages of EVARREST at 2 to 25°C. EVARREST does not require refrigeration. Do not freeze.
• Do not use if package is opened or damaged.
• Once opened, keep EVARREST dry to avoid activation of the biological components prior to use.

• Dailymed label info on Evarrest
• FDA Evarrest

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