Fibrin Sealant (Human)

Pronunciation: FYE-brin
Class: Fibrin agent, Topical hemostatic

Trade Names

Artiss
- Solution, topical 2 mL
- Solution, topical 4 mL
- Solution, topical 10 mL

Artiss Kit
- Lyophilized powder for solution, topical 2 mL
- Lyophilized powder for solution, topical 4 mL
- Lyophilized powder for solution, topical 10 mL

TachoSil
- Patch, topical fibrinogen 337.4 mg/thrombin 123.1 units (9.5 cm × 4.8 cm)
- Patch, topical fibrinogen 170.5 mg/thrombin 62.2 units (4.8 cm × 4.8 cm)

Tisseel
- Solution, topical 2 mL
- Solution, topical 4 mL
- Solution, topical 10 mL

Tisseel Kit
- Lyophilized powder for solution, topical 2 mL
- Lyophilized powder for solution, topical 4 mL
- Lyophilized powder for solution, topical 10 mL

Pharmacology

Adheres to the wound surface and achieves sealing or gluing of tissues (topical solution). Forms a fibrin clot that adheres the collagen patch to the wound surface and achieves hemostasis ( TachoSil ).

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Pharmacokinetics

Absorption

Because fibrin sealant is only applied topically, systemic exposure is not expected.

Distribution

Because fibrin sealant is only applied topically, distribution to other organs or tissues is not expected.

Elimination

Tisseel is expected to be completely resorbed in 10 to 14 d. Half-life is 30 to 60 min (aprotinin and its metabolites).

Onset

Polymerization takes approximately 60 sec (topical solution).

Indications and Usage

To adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adults and children 1 y and older; to adhere tissue flaps during facial rhytidectomy surgery (face lift).

Adjunct to hemostasis for use in CV surgery when control of bleeding by standard surgical techniques (eg, cautery, ligature, suture) is ineffective or impractical.

Adjunct to hemostasis in surgeries when control of bleeding by standard surgical techniques (eg, cautery, ligature, suture) is ineffective or impractical; adjunct to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Contraindications

Hypersensitivity to aprotinin and/or any component of the product ( Artiss / Tisseel ); hypersensitivity to human blood products or horse proteins ( TachoSil ); severe or brisk arterial bleeding ( Tisseel ); intravascular administration.

Dosage and Administration

Topical Dose depends on size of surface being covered. The approximate areas requiring tissue flap adherence covered by each package size are as follows: for 100, 200, or 500 cm ² , the required package sizes are 2, 4, and 10 mL, respectively.

Topical The selection and number of patches to be applied should be determined by the size of the bleeding area to be treated. Select the appropriate patch so that it extends 1 to 2 cm beyond the margins of the wound. The patch can be cut to the correct size and shape if desired. If more than 1 patch is used, overlap patches by at least 1 cm. Do not exceed 7 patches sized 9.5 × 4.8 cm or 14 patches sized 4.8 × 4.8 cm.

Topical Dose depends on size of surface being covered. The approximate surface areas covered by each package size are as follows: for a maximum size area to be sealed using cannula of 8, 16, or 40 cm ² or for a maximum size area to be sealed using spray of 100, 200, or 500 cm ² , the required package sizes are 2, 4, and 10 mL, respectively.

Topical Dose depends on size of surface being covered. The approximate areas requiring skin graft fixation covered by each package size are as follows: for 100, 200, or 500 cm ² , the required package sizes are 2, 4, and 10 mL, respectively.

General Advice

• For topical use only. Do not inject topical solutions. Do not use intravascularly.
• Consult package insert for directions for preparing and applying fibrin sealant.
• Vials and prefilled syringes are for single use only; discard unused content.

Storage/Stability

Store frozen prefilled syringes at or below −4°F. Unopened Artiss pouches, thawed at room temperature, may be stored for up to 14 days between 59° and 77°F after removal from the freezer. The product must be used within 12 h after warming to 92° to 98.6°F or after removal from the original pouches. Application must be completed within 4 h after opening the syringe. Thawed, unopened Tisseel pouches may be stored for up to 48 h at 59° to 77°F after removal from the freezer. Total thawing and warming time cannot exceed 48 h for Tisseel . Do not refrigerate or refreeze solution after thawing. Do not microwave.

Store powder for solution between 36° and 77°F. Do not expose to temperatures above 98.6°F. Avoid freezing. After reconstitution, product must be used within 4 h. Reconstituted solutions must not be refrigerated or frozen.

Store between 36° and 77°F. Do not freeze. Refrigeration is not required. Discard unused, opened packages.

Drug Interactions

Oxycellulose-containing preparations may reduce the efficacy of fibrin sealant and should not be used as carrier materials.

Adverse Reactions

Cardiovascular

Atrial fibrillation (29%); pleural effusion (23%); tachyarrhythmia (7%); pericardial effusion (5%); bradycardia, flushing, hypotension, phlebitis, tachycardia, thromboembolic complications, thrombosis (postmarketing).

Dermatologic

Skin graft failure (3%); pruritus (1%); angioedema, erythema, impaired wound healing, urticaria (postmarketing).

Genitourinary

Renal artery thrombosis, renal failure (postmarketing).

Hematologic

Hemorrhagic anemia (8%); postprocedural hemorrhage (5%); hematoma (1%); eosinophilia, hemorrhage (postmarketing).

Hepatic

Biloma, hepatitis C, portal vein thrombosis, splenic hemorrhage (postmarketing).

Hypersensitivity

Anaphylactic responses, anaphylactic shock, hypersensitivity (postmarketing).

Respiratory

Bronchospasm, dyspnea, hemothorax, laryngeal edema, postprocedural pulmonary embolism, respiratory distress, wheezing (postmarketing).

Miscellaneous

Pyrexia (7%); abscess, air embolism, catheter-related complication, edema, foreign body trauma, granuloma, impaired healing, inflammation, multiorgan failure, mydriasis, nausea, nerve compression, paralysis or other compression complications, parathyroid disorder, paresthesia, seroma (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 1 y for skin graft adhesions.

Safety and efficacy not established.

Hypersensitivity

Hypersensitivity, allergy, or anaphylactoid reactions may occur.

Application

Apply topical solution as a thin layer; excessive clot thickness may interfere with efficacy and the wound healing process. Do not apply intravascularly. Intravascular administration may result in life-threatening thromboembolic events. When using fibrin sealant in surgery, exercise caution to minimize the risk of inadvertent intravascular application.

Closed/Confined spaces

When placing TachoSil into cavities or closed spaces, avoid overpacking because this may cause compression of underlying tissue. Use only the minimum necessary to achieve hemostasis. The safety and effectiveness of Tisseel used alone or in combination with biocompatible carriers in surgeries involving confined spaces and neurological procedures have not been evaluated, and its use in this setting is not approved by the FDA.

Contaminated spaces

Do not leave TachoSil in an infected or contaminated space because it may potentiate an existing infection.

Embolism

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. This appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. Follow the manufacturer's recommendations for pressure and distance from the tissue surface when applying fibrin sealant using a spray device.

Infections

Because fibrin sealant is made from human plasma, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.

Primary hemostasis

Do not use as the primary mode to control hemostasis. Fibrin sealant is not intended as a substitute for meticulous surgical technique and the proper application of suture, ligature, or other conventional procedures for hemostasis.

Severe/Brisk bleeding

Do not use fibrin sealant for the treatment of severe or brisk arterial or venous bleeding. In these situations, fibrin sealant will be washed away in the flow of blood before hemostasis can be attained.

Topical cleansers

Sealer protein and thrombin solutions can be denatured by alcohol, iodine, or heavy metal ions. If any of these substances have been used to cleanse the area of fibrin sealant application, the area must be rinsed and made as dry as possible before applying fibrin sealant.

Overdosage

Symptoms

Excess granulation tissue.

Patient Information

• Advise patients that because fibrin sealant is made from human blood, it may carry a risk of transmitting infections agents (eg, viruses, and theoretically, the Creutzfeldt-Jakob disease agent).
• Instruct patients to consult their health care provider if symptoms of B19 virus infection appear (fever, drowsiness, chills, and runny nose, followed about 2 wk later by a rash and joint pain).

Copyright © 2009 Wolters Kluwer Health.