Fibrinogen and Thrombin, Human (topical)

Fibrinogen and thrombin, human is a topically applied drug that is used to during surgery to control bleeding.

Overview

In the US, fibrinogen and thrombin, human is known by the brand names, Evarrest, Tachosil and Raplixa. The drug is only used in a hospital or clinic setting during surgical procedures and is not generally prescribed to patients for use outside of this environment. The medication comes in the form of a powder for dusting onto wounds, a sheet, a pad and a sponge.

Fibrinogen and thrombin, human in its various forms is one of a class of medications called fibrin sealants. The drug is used during surgical procedures to close incisions or wounds where it has not been possible to use other means, such as heat, staples or stitches.

The drug is made from synthetic proteins, which are very effective at stopping bleeding by assisting the blood's clotting function. Fibrinogen and thrombin, human is generally only used by medical professionals.

Condition(s) treated

  • To control bleeding during surgery

Type of medicine

  • Fibrin sealant
  • Pad
  • Powder
  • Sponge
  • Sheet

Side effects

In addition the effects it is designed to have, fibrin and thrombin, human may cause a few unwanted side effects. You may not experience any of these effects, but if they do happen, you should tell your doctor or nurse straight away:

  • Wounds not healing
  • Unusually warm skin
  • Unusual tiredness or weakness
  • Trouble speaking or walking
  • Swelling or puffiness of the eyelids or around the face, eyes, tongue or lips
  • Sweating
  • Sudden, severe weakness or numbness in the leg or arm
  • Sudden, severe headache
  • Sudden loss of coordination
  • Slurred speech
  • Shortness of breath
  • Severe, dark colored bruising
  • Redness or flushing of the skin
  • Rapid, slow, pounding, or irregular pulse or heartbeat
  • Problems swallowing
  • Pain, itching, swelling, or reddening of the skin, treated area or wound site
  • Pain in the groin, chest, or legs, particularly the calves
  • Numbness or tingling in the legs, arms or face
  • Large, swellings on the face, lips, eyelids, tongue, hands, throat, feet, legs or genitals
  • Itching, skin rash, hives
  • Fainting, feeling dizzy or lightheaded when rising from a seated or prone position
  • Cough
  • Confusion
  • Chest pain, tightness or discomfort
  • Breathing difficulties
  • Blurred vision
  • Accumulation of fluid underneath the skin

There are some side effects that are caused by fibrinogen and thrombin, human that will disappear by themselves and do not need any more medical intervention. However, if any of the effects mentioned in the following list persist or are especially troubling, you should mention them to your treating physician:

  • Feelings of burning, itching, crawling, numbness, tingling, prickling or "pins and needles"
  • Nausea

It should be noted by patients that the side effects mentioned in this guide are not necessarily the only ones that have been experienced by people being treated with this drug. If you notice anything else, you should check with your nurse or doctor.

Dosage

When using fibrinogen and thrombin, human topical applications, the wound site and surrounding area should be as dry as possible.

A thin layer of sealant should be applied so that the area is entirely covered. If necessary, the application should be repeated. The dose will depend on the size of the area to be covered and the patient's condition.

Guidelines for use

  • Ensure that the wound surface and surrounding site is dry.
  • Apply sufficient product to cover the area completely.
  • Once the first component of the treatment has been applied, proceed to apply the second component.
  • Hold or fix the two sealed parts into position for between three and five minutes, ensuring that the fibrin sealant has firmly adhered to the tissue surrounding it.
  • Wet gloves and surgical instruments with saline before handling the product to prevent it from sticking.

Drug interactions

There are no reported drug interactions for fibrinogen and thrombin, human. However, you should tell your treating physician if you are currently taking any other medication, including non-prescription products, herbal remedies and vitamin supplements.

Medical interactions

There have been a small number of incidents reported where serious adverse events have taken place, including paralysis that are possibly related to the use of this medicine with resorbable hemostatic agents.

In very rare cases severe allergic reactions, including anaphylaxis have been reported.

Some patients have reported cardiovascular interactions, including hypotension, tachycardia, bradycardia and thromboembolic complications.

There have been rare incidents of dyspnea and other respiratory problems in patients who have been treated with fibrinogen-thrombin.

Some people report a skin reaction following treatment with this drug, including pruritus, flushing, and urticaria. Some patients report feelings of nausea after they have received treatment with this medicine.

Sometimes fibrin sealant may fragment post-operatively, producing a D-dimer. However, this is a rare occurrence. If you feel at all unwell following treatment with fibrinogen and thrombin, human, you should consult your doctor or nurse without delay.

Warnings

It should be noted that some components of fibrinogen and thrombin, human are made from human plasma. In theory, this means that there is the potential for the transmission of certain viral diseases. Before agreeing to treatment with this drug, you should discuss the potential risks of doing so with a member of your treating team.

If you experience any of the following symptoms immediately following treatment with this medication, you should tell your doctor or nurse. These signs can indicate an anaphylactic shock reaction, which is potentially very serious:

  • Rapid or irregular heartbeat
  • Breathing difficulties
  • Swelling of the throat, tongue or lips
  • Nausea
  • Fainting

Exposure to iodine or alcohol may affect the use of fibrinogen and thrombin, human. Tell your doctor if you have recently been in contact with these substances.

It should be noted that the Evarrest patches can cause thrombosis if they are systemically absorbed. For this reason, the minimal number of patches should be used to cover the treatment site to avoid the risk of degraded patch material migrating into the bloodstream. Evarrest patches should not be used instead of stitches or staples when treating major bleeding of blood vessels.

Evarrest patches should not be used in areas where there is an active infection or contamination. They should not be used around areas of bone where swelling could compress blood vessels. Do not use patches for minimally invasive surgery where it will be difficult to achieve manual compression.

Tachosil patches may contain equine collagen. If you have an allergy to horse protein, you should tell your doctor. Care should be taken not to over-pack wounds with Tachosil patches.

Tisseel may contain synthetic proteins. For this reason, it should not be used with any preparations that contain oxycellulose, as doing so could decrease its effectiveness. It is not recommended that Tisseel is used for neurological procedures.

Fibrinogen and thrombin, human is for topical use only. It must never be used as an injectable. Inadvertent intravascular use could be life-threatening.

When treating homoeostasis, use only the minimal amount necessary. Using too much fibrinogen and thrombin, human could cause problems with wound healing and may reduce the efficacy of the product.

Use only recommended regulators, applicator positions, and pressure ranges when applying fibrinogen and thrombin, human to avoid the risk of air or gas embolism.

Patches should not be used as a substitute for staples or sutures when treating major vessel bleeding. Evarrest patches should not be used in children aged under one month. The application is difficult due to the size of the patches. Do not cut the patches to fit.

There is no evidence to suggest that fibrinogen and thrombin, human presents a danger to the unborn baby. However, if you are expecting a baby, you should tell your treatment team. Similarly, there is nothing to suggest that fibrinogen and thrombin, human passes into breast milk where it could present a risk to the nursing infant. If you are breastfeeding, you should mention this to your treating team and perhaps consider changing your feeding method until your treatment with fibrinogen and thrombin, human has been completed.

Before you begin treatment with fibrinogen and thrombin, human, you should make sure that a full discussion of your medical history and medication takes place with your doctor. Check that you understand how the product works and be fully appraised of any risks that are associated with its use.

Storage

Fibrinogen and thrombin, human is only used by trained medical professionals during surgical procedures in a hospital setting. You will not be required to store the drug at home.

Summary

Fibrinogen and thrombin, human topical belongs to a group of drugs that are called fibrin sealants. Fibrin sealants are widely used during routine surgical procedures to help in closing incisions or wounds in place of or to support other closure methods, including heat, staples or stitches. Fibrin is a clotting agent, helping to prevent and stop bleeding.

There are a few side effects to note, but this medication has no noted drug interactions. However, you should ensure that you disclose your full medical history to your treating physician before you begin your treatment with this medicine. You will be required to attend regular update appointments after your surgery. These sessions will allow your doctor to check for any unexpected complications or side effects that may have been caused by the use of fibrinogena and thrombin, human.