Fibrin Sealant, Human

Fibrin sealant (human) is a prescription medication used to control bleeding during surgery.

Fibrin sealant (human) contains two proteins normally found in human blood that help the blood clot: fibrinogen and thrombin.

Fibrin sealant (human) is available as a topical spray and can be used as needed during surgery to control bleeding. It should be used in conjunction with an absorbable gelatin sponge.

Common side effects of fibrin sealant (human) include surgical pain, nausea, constipation, fever, and decreased blood pressure.

Fibrin sealant (human) is a prescription medication used to control bleeding during surgery when standard surgical techniques are ineffective at controlling bleeding.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Fibrin Sealant, Human may be found in some form under the following brand names:

• Artiss

• Raplixa

Serious side effects have been reported with fibrin sealant (human). See the “Fibrin sealant, human Precautions” section.

Common side effects of fibrin sealant (human) include the following:

• surgical pain
• nausea
• constipation
• fever
• decreased blood pressure

This is not a complete list of fibrin sealant (human) side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No fibrin sealant (human) drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with fibrin sealant (human) including the following:

• the transmission of serious infectious agents, such as viruses and Creutzfeldt-Jakob disease agents. Tell your healthcare provider right away if you have any of the following symptoms of an infection:
  • fever
  • drowsiness
  • chills
  • rash
  • joint pain
  • loss of appetite
  • abdominal pain
  • dark urine
  • yellowing of the skin or eyes
• thromboembolism. Tell your healthcare provider right away if you have any of the following symptoms of a thromboembolism:
  • chest pain
  • shortness of breath
  • difficulty speaking or swallowing
  • leg tenderness or swelling

Do not use fibrin sealant (human) if you:

• are allergic to fibrin sealant (human) or to any of its ingredients
• have had hypersensitivity reactions to any human blood products

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fibrin sealant (human), there are no specific foods that you must exclude from your diet when receiving this medication.

Before using, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to fibrin sealant (human) or to any of its ingredients or to any human blood products
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Animal reproduction studies have not been conducted with fibrin sealant (human). It is also not known whether fibrin sealant (human) can cause fetal harm when administered to pregnant women or can affect reproductive capacity. Fibrin sealant (human) should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if fibrin sealant (human) crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, caution should be exercised when administering fibrin sealant (human) to a nursing woman.

Use fibrin sealant (human) exactly as prescribed.

Fibrin sealant (human) is available as a topical spray and can be used as needed during surgery to control bleeding. It should be used in conjunction with an absorbable gelatin sponge.

Do not inject fibrin sealant (human) into a vein.

Do not use fibrin sealant (human) for the treatment of severe or brisk arterial bleeding.

Use this medication exactly as indicated.

The dose your doctor uses may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication

The required dose of fibrin sealant (human) depends on the size of the bleeding area to be treated.

If you take too much fibrin sealant (human), call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If fibrin sealant (human) is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store fibrin sealant (human) between 2°C and 25°C (36°F and 77°F). Refrigeration is not required. Do not freeze.
• Use fibrin sealant (human) within 1 hour of opening vial.
• Keep this and all medicines out of the reach of children.