Evarrest

Fibrinogen and thrombin human topical powder or patch is used to help control bleeding during surgery when other procedures to close a wound or incision, such as stitches, bands, and heat cannot be used. This medicine is a fibrin sealant.

This medicine contains man-made proteins (fibrinogen and thrombin) that are used to stop bleeding by helping the blood to clot.

This medicine is to be given only by or under the supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fibrinogen and thrombin human topical powder or patch in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fibrinogen and thrombin human topical powder or patch in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to human blood products, history of or
• Arterial bleeding, severe or brisk or
• Infection on any part of the body or at the application site—Should not be used in patients with these conditions.

Applies to fibrin sealant topical: topical kit, topical solution

General

General side effects have been reported including rare reports of serious adverse events such as paralysis and other compressive complications possibly related to the use of fibrin sealant in combination with resorbable hemostatic agents. There have also been rare reports of fatalities following the misadministration of topical thrombin.[Ref]

Hypersensitivity

Hypersensitivity side effects such as anaphylactic and anaphylactoid reactions including shock have been reported rarely.[Ref]

Cardiovascular

Cardiovascular side effects including tachycardia, bradycardia, hypotension, and thromboembolic complications have been reported rarely.[Ref]

Respiratory

Respiratory side effects including severe dyspnea have been reported rarely.[Ref]

Dermatologic

Dermatologic side effects including flush, urticaria, and pruritus have been reported rarely.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea have been reported rarely.

Other

A D-dimer is a fragment produced during the degradation of a clot. Postoperatively increased D-dimers may result at least partly from the degradation of fibrin sealant.[Ref]

Other side effects including increased D-dimer levels have been reported in a clinical study on cardiovascular surgery, but did not exceed values reported in the literature occurring after this type of surgery.[Ref]

Some side effects of Evarrest may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.