Fibrinogen and thrombin, human (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, like 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 checks you closely while you are receiving this medicine to ensure 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 weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have been no appropriate studies on the effects of fibrinogen and thrombin, human topical powder or patch in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of fibrinogen and thrombin, human topical powder or patch.

Breast Feeding

There have not been adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if interactions might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform 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 around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use 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—This medicine should not be used in patients with these conditions.

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

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.