Fibrin Sealant (Human)

Trade Names:
Artiss
- Powder for solution, topical 2 mL
- Powder for solution, topical 4 mL
- Powder for solution, topical 10 mL

Trade Names:
Artiss
- Solution, topical 2 mL
- Solution, topical 4 mL
- Solution, topical 10 mL

Trade Names:
Tisseel
- Powder for solution, topical 2 mL
- Powder for solution, topical 4 mL
- Powder for solution, topical 10 mL

Trade Names:
Tisseel
- Solution, topical 2 mL
- Solution, topical 4 mL
- Solution, topical 10 mL

Pharmacology

Fibrin adheres to the wound surface and achieves sealing or gluing of tissues.

Pharmacokinetics

Onset

Polymerization takes approximately 60 seconds.

Indications and Usage

Adhere autologous skin grafts to surgically prepared wound beds resulting from burns.

Adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries; adjunct in the closure of colostomies.

Contraindications

Intravascular administration; hypersensitivity to aprotinin or any component of the product; bovine protein hypersensitivity ( Tisseel ).

Dosage and Administration

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

Consult package insert for directions for preparing fibrin sealant.

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 of 8, 16, or 40 cm ² or for maximum 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.

Consult package insert for directions for preparing fibrin sealant.

General Advice

• For topical use only. Do not inject.

Storage/Stability

Store at 36° to 77°F. Avoid freezing. After reconstitution, product must be used within 4 h.

Prefilled syringes may be stored at −4°F.

Unopened pouches, thawed at room temperature, may be stored for up to 7 days at room temperature (59° to 77°F) after removal from the freezer. The product must be used within 12 hours after warming to 92° to 98.6°F or removal from original pouches. Do not refrigerate, microwave or refreeze.

Store at 36° to 77°F. Avoid freezing.

Store at −4°F or less.

Thawed, unopened pouches may be stored for up to 48 h at room temperature (59° to 77°F) after removal from the freezer. Do not refrigerate or refreeze. After reconstitution of the solution and opening the package, fibrin sealant must be used within 4 h.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Bradycardia, hypotension, tachycardia, thromboembolic complications (postmarketing).

Dermatologic

Pruritus, skin graft failure (more than 1%); dermal cyst, graph necrosis; urticaria (postmarketing).

GI

Nausea (postmarketing).

Hypersensitivity

Anaphylactic responses, hypersensitivity (postmarketing).

Respiratory

Dyspnea, mediastinal and thoracic disorders (postmarketing).

Miscellaneous

Edema, flushing, impaired healing, paralysis or other compression complications, pyrexia, seroma (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 1 yr of age.

Safety and efficacy not established.

Elderly

Clinical studies did not include subjects 65 years of age and older.

No overall differences in safety and efficacy were observed between elderly and younger subjects.

Hypersensitivity

Hypersensitivity, allergy, or anaphylactoid reactions may occur.

Application

Apply fibrin sealant as a thin layer; excessive clot thickness may interfere with efficacy and the wound healing process.

Cardiopulmonary surgery

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

Infections

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

Overdosage

Symptoms

None reported.

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