Pronunciation:

fye-BRIN-oh-jen, THROM-bin, HUE-man

Brand Names:

• Evarrest
• Raplixa
• Tachosil

Dosage Forms:

• Solution
• Sheet

Classifications:

Therapeutic—

Fibrin Sealant

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Other 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.

Other interactions—

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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

Blurred vision

confusion

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

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 need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue 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, check with 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.