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fibrinogen/thrombin, human (Topical application route)

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

Commonly used brand name(s)

In the U.S.

  • Evarrest
  • Raplixa
  • Tachosil

Available Dosage Forms:

  • Sheet
  • Powder
  • Pad
  • Sponge

Therapeutic Class: Fibrin Sealant

Uses For fibrinogen/thrombin, human

Fibrinogen and thrombin human topical powder 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. fibrinogen/thrombin, human is a fibrin sealant.

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

fibrinogen/thrombin, human is to be given only by or under the supervision of your doctor.

Before Using fibrinogen/thrombin, human

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 fibrinogen/thrombin, human, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to fibrinogen/thrombin, human 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.


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


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


Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 fibrinogen/thrombin, human. 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—Should not be used in patients with these conditions.

Proper Use of fibrinogen/thrombin, human

A doctor or other trained health professional will give you fibrinogen/thrombin, human. fibrinogen/thrombin, human is applied only to your skin or incision during surgery. It may be used with a sponge or a spray applicator.

fibrinogen/thrombin, human should not be given as an injection.

Precautions While Using fibrinogen/thrombin, human

It is very important that your doctor check you closely while you are receiving fibrinogen/thrombin, human to make sure it is working properly.

fibrinogen/thrombin, human 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 fibrinogen/thrombin, human.

fibrinogen/thrombin, human 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.

fibrinogen/thrombin, human 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 fibrinogen/thrombin, human.

fibrinogen/thrombin, human Side Effects

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 place of application
  • pale skin
  • pounding in the ears
  • slow or fast heartbeat
  • sweating
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

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.

See also: Side effects (in more detail)

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