Evarrest (Topical application)

Fibrinogen and thrombin human topical powder or patch is used to help control bleeding during surgery when other methods 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 help stop bleeding by aiding blood clotting.

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

It is very important that your doctor check you closely while you are receiving this medicine to make sure it is working properly.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, trouble breathing or swallowing, swelling or tenderness in your leg, or numbness or weakness while you are receiving this medicine.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine against the benefits it will provide. For this medicine, please keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, including those to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how age affects the effects of fibrinogen and thrombin human topical powder or patch in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults 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 to determine the risk to infants when using this medication during breastfeeding. You should weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used at the same time even if an interaction could happen. In these situations, your doctor may need to adjust the dose, or take other precautions. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, 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.

Along with its required effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Blurred vision
• Confusion
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting
• Headache
• Nervousness
• Pain at the application site
• Pale skin
• Pounding in the ears
• Slow or fast heartbeat
• Sweating
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Less common

• Bleeding

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

More common

• Constipation
• Fever
• Itching skin
• Nausea
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Evarrest
• Raplixa
• Tachosil

Available Dosage Forms:

• Solution
• Sheet

Therapeutic Class: Fibrin Sealant

A doctor or other trained health professional will give you this medicine. This medicine is applied only to your skin or incision during surgery.

This medicine may be used with a sponge or a spray applicator. It should not be given as an injection.