Fibrin Sealant

Fibrin Sealant is a prescription medication indicated:

• as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques (eg, suture, ligature, cautery) is ineffective or impractical 
• to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations aged 1 year and older
• Fibrin Sealant is available under the following different brand names: Evicel, Tisseel VH, Artiss, TachoSil

Common side effects of Fibrin Sealant include:

• slow heart rate
• nausea
• low blood potassium
• insomnia
• low blood pressure (hypotension)
• fever
• graft infection
• vascular graft occlusion
• swelling of extremities
• constipation

Serious side effects of Fibrin Sealant include:

• chest pain
• cough 
• trouble breathing
• gasping for breath
• confusion 
• agitation 
• panic 
• extreme fear
• sudden numbness or weakness (especially on one side of the body)
• sudden severe headache, slurred speech, problems with vision or balance
• blue-colored appearance of the skin or lips
• nausea, dizziness, or spinning sensation
• light-headache feeling
• redness, itching, irritation, or slow healing of the skin wound or treated area

Rare side effects of Fibrin Sealant include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Kit

• 67-106 mg/mL fibrinogen: 2.5-6.5 units/mL thrombin (Artiss)
• 67-106 mg/mL fibrinogen: 400-625 units/mL thrombin (Tisseel)
• 55-85 mg/mL fibrinogen and 800 units/mL thrombin (Evicel)

Patch

• 3.6-7.4 mg/cm2 fibrinogen and 1.3-2.7 units/cm2 (TachoSil)

Adjunct to hemostasis

Adult dosage

• Follow Mfr's instructions for reconstitution and application

Evicel

• Spray or drop onto the surface of bleeding tissues in short bursts (0.1-0.2 mL); if the hemostatic effect is not complete, apply a second layer; if the maximum area to be sealed is 20 cm2, use 2 mL
• If the maximum area to be sealed is 20 cm2, use 2 mL
• If the maximum area to be sealed is 40 cm2, use 4 mL
• If the maximum area to be sealed is 100 cm2, use 10 mL

TachoSil Patch

• If the maximum number of patches to be applied is 7 apply patch size 9.5 cm × 4.8 cm
• If the maximum number of patches to be applied is 14 apply patch size 4.8 cm × 4.8 cm
• If the maximum number of patches to be applied is 42 apply patch size 3.0 cm × 2.5 cm

Tisseel VH

• May be used in fully heparinized patients undergoing cardiopulmonary bypass
• Sealing: Indicated as an adjunct to standard surgical techniques (eg, suture, ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
• If the maximum area to be sealed is 8 cm2 via a cannula or 100 cm2 using a spray, use 2 mL
• If the maximum area to be sealed is 16 cm2 via a cannula or 200 cm2 using spray, use 4 mL
• If maximum area to be sealed 40 cm2 via cannula or 500 cm2 using spray, use 10 mL

Pediatric dosage

• Follow Mfr's instructions for reconstitution and application
• Evicel
  • Children younger than 6 months: Safety and efficacy not established
  • Children aged 6 months and older: Spray or drop onto the surface of bleeding tissues in short bursts (0.1-0.2 mL); if the hemostatic effect is not complete, apply a second layer; if the maximum area to be sealed is 20 cm2, use 2 mL
    • If the maximum area to be sealed is 20 cm2, use 2 mL
    • If the maximum area to be sealed is 40 cm2, use 4 mL
    • If the maximum area to be sealed is 100 cm2, use 10 mL
• Tisseel
• Children younger than a month: Safety and efficacy not established
• Children aged 1 month and older
  • If the maximum area to be sealed is 8 cm2 via a cannula or 100 cm2 using a spray, use 2 mL
  • If the maximum area to be sealed is 16 cm2 via a cannula or 200 cm2 using a spray, use 4 mL
  • If maximum area to be sealed 40 cm2 via cannula or 500 cm2 using spray, use 10 mL

Autologous skin graft adherence

Adult dosage

• Artiss
  • If the graft fixation area is 100 cm2, use 2 mL
  • If the graft fixation area is 200 cm2, use 4 mL
  • If the graft fixation area is 500 cm2, use 10 mL

Pediatric dosage

• Children younger than 1 year of age: Safety and efficacy not established
• Graft fixation area
  • If the graft fixation area is 100 cm2, use 2 mL
  • If the graft fixation area is 200 cm2, use 4 mL
  • If the graft fixation area is 500 cm2, use 10 mL

Tissue flap adherence in facelift

Adult dosage

• Artiss
  • Spray topically in an even thin layer over the wound bed immediately before attaching the skin flap
  • If the graft fixation area is 100 cm2, use 2 mL
  • If the graft fixation area is 200 cm2, use 4 mL
  • If the graft fixation area is 500 cm2, use 10 mL

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fibrin Sealant has no noted severe interactions with any other drugs
• Fibrin Sealant has no noted serious interactions with any other drugs
• Fibrin Sealant has no noted moderate interactions with any other drugs
• Fibrin Sealant has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to product or other components
• Massive or brisk arterial bleeding
• Intravascular use — risk for life-threatening thromboembolic events
• Do not spray product where the minimum recommended distance from the applicator tip to the target site cannot be assured

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fibrin Sealant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fibrin Sealant?”

Cautions

• Theoretical risk for exposure to blood-borne pathogens
• Exposure to iodine, alcohol, or heavy metal may denature fibrinogen and thrombin proteins; if used, rinse the area before applying fibrin Sealant
• Air or gas embolism may occur when administered via a spray device; avoid a pressure of more than 20-25 psi
• Artiss is not to be used for hemostasis (not indicated)
• Tisseel is not to be used with oxycellulose-containing preparations; may decrease efficacy

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Excretion in milk unknown; use with caution