Raplixa (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 assisting the blood in clotting.

This medicine should only be given by your doctor or under their supervision.

It is very important that your doctor monitors you closely while you are receiving this medicine to ensure it is working properly.

This medicine may increase your risk of blood clotting problems. Inform your doctor immediately if you experience a sudden or severe headache, issues with vision or speech, chest pain, difficulty breathing or swallowing, swelling or tenderness in your leg, or numbness or weakness while using this medicine.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Notify your doctor right away if you develop a rash, itching, hives, chest pain, dizziness or lightheadedness, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth after using 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 minimize the transmission risk. Discuss this risk with your doctor if you have concerns.

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care provider about any other allergies you may have, including allergies to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

So far, studies have not shown any specific problems in elderly patients that would limit the use of fibrinogen and thrombin human topical powder or patch.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication while 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 there is a chance of interaction. In these situations, your doctor may want to adjust the dose or take additional precautions. Inform your healthcare professional if you are taking any other prescription or 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 because interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor about any other medical issues you have, especially:

• Allergy to human blood products, history of or
• Severe or brisk arterial bleeding 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 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.

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.