Fibrin Sealant (Human)

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

Trade Names

Artiss
- Powder for solution, topical 2 mL
- Powder for solution, topical 4 mL
- Powder for solution, topical 10 mL

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

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

Tisseel
- Powder for solution, topical 2 mL
- Powder for solution, topical 4 mL
- Powder for solution, topical 10 mL

Tisseel
- Solution, topical 2 mL
- Solution, topical 4 mL
- 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 ).

Pharmacokinetics

Absorption

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

Distribution

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

Onset

Polymerization takes approximately 60 sec (topical solution).

Indications and Usage

Artiss

To adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adults and children.

TachoSil

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

Tisseel

Adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen when control of bleeding by standard surgical techniques (eg, suture, ligature, cautery) is ineffective or impractical; adjunct to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Contraindications

Intravascular administration; hypersensitivity to aprotinin and/or any component of the product; severe or brisk arterial bleeding ( Tisseel ), bovine protein hypersensitivity ( Tisseel ); hypersensitivity to human blood products or horse proteins ( TachoSil ).

Dosage and Administration

Hemostasis in Cardiovascular Surgery ( TachoSil only)
Adults

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.

Hemostasis in Surgeries; Colostomy Closure ( Tisseel only)
Adults

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

Skin Graft Adherence ( Artiss only)
Adults and Children 1 y and older

Topical Dose depends on size of surface being covered. The approximate surface areas covered by each package size are as follows: for a max size area to be sealed of 8, 16, or 40 cm ² or for a max size area to be sealed using compressed gas of 100, 200, or 500 cm ² , the required package size is 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

Artiss Prefilled syringe

Store frozen prefilled syringes at −4°F. Unopened 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 hours after warming to 92° to 98.6°F or after removal from original pouches. Do not refrigerate, microwave, or refreeze.

Vials

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.

TachoSil

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

Tisseel Prefilled syringe

Store frozen pre-filled syringe at or below −4°F. Thawed, unopened pouches may be stored for up to 48 h between 59° and 77°F after removal from the freezer. Do not refrigerate or refreeze.

Vials

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

Drug Interactions

Oxycellulose

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

Dermal cyst, graft detachment/nonadherence and/or necrosis, skin graft failure; pruritus, urticaria (postmarketing).

Genitourinary

Renal artery thrombosis, renal failure (postmarketing).

Hematologic

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

Hepatic

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

Hypersensitivity

Anaphylactic responses, hypersensitivity (postmarketing).

Respiratory

Dyspnea, hemothorax, laryngeal edema, postprocedural pulmonary embolism, respiratory distress (postmarketing).

Miscellaneous

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

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Artiss

Safety and efficacy not established in children younger than 1 y.

TachoSil , Tisseel

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. When using Tisseel in cardiopulmonary bypass surgery, exercise caution to minimize the risk of inadvertent intravascular application.

TachoSil

Do not apply intravascularly. Intravascular administration may result in life-threatening thromboembolic events. Do not leave TachoSil in an infected or contaminated space because it may potentiate an existing infection. 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.

Arterial bleeding

Do not use TachoSil for the treatment of severe or brisk arterial bleeding.

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.

Tisseel

The safety and effectiveness of Tisseel used alone or in combination with biocompatible carriers in surgeries involving confined spaces and neurological procedures has not been evaluated and its use in this setting is not approved by the FDA.

Overdosage

Symptoms

None well documented.

Patient Information

• Advise patients that because fibrin sealant is made from human blood, it may carry a risk of transmitting infections agents (eg, viruses, 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.