Thrombin

Thrombin is used in the treatment of:

• Hemorrhage

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

Thrombin may be found in some form under the following brand names:

• Artiss

• Evithrom

• Recothrom

• TachoSil

• Thrombin-JMI

• Thrombogen

• Tisseel

Take thrombin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Thrombin dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Thrombin is available in the following doses:

• Fibrin Sealant Topical 10 Ml Topical Kit
• Fibrin Sealant Topical 2 Ml Topical Kit
• Fibrin Sealant Topical 4 Ml Topical Kit
• Fibrin Sealant Topical Topical Solution
• Fibrinogen-thrombin Topical Topical Solution
• Thrombin Topical 1000 Units Topical Powder For Reconstitution
• Thrombin Topical 10000 Units Topical Kit
• Thrombin Topical 10000 Units Topical Powder For Reconstitution
• Thrombin Topical 20000 Intl Units Topical Powder For Reconstitution
• Thrombin Topical 20000 Units Topical Kit
• Thrombin Topical 5000 Intl Units Topical Powder For Reconstitution
• Thrombin Topical 5000 Units Topical Kit
• Thrombin Topical 5000 Units Topical Powder For Reconstitution
• Thrombin Topical 50000 Units Topical Powder For Reconstitution
• Thrombin Topical Bovine 20,000 Intl Units Topical Powder For Reconstitution
• Thrombin Topical Bovine 5000 Intl Units Nasal Powder For Reconstitution
• Thrombin Topical Bovine 5000 Intl Units Topical Powder For Reconstitution
• Thrombin Topical Human 2500 Intl Units Topical Kit
• Thrombin Topical Human 2500 Intl Units Topical Powder For Reconstitution
• Thrombin Topical Human 5000 Intl Units Topical Powder For Reconstitution
• Thrombin Topical Human Topical Powder For Reconstitution
• Thrombin Topical Human Topical Solution
• Thrombin Topical Recombinant 20,000 Intl Units Topical Powder For Reconstitution
• Thrombin Topical Recombinant 5000 Intl Units Topical Powder For Reconstitution

Hemostatic agent.100 b

Contraindications

• Known sensitivity to any ingredient in the formulation and/or to material of bovine origin.100

Warnings/Precautions

Warnings

Because of its hemostatic activity, thrombin should not be injected or otherwise allowed to enter large blood vessels; may result in extensive intravascular clotting and even death.100 102

Abnormalities in hemostasis reported, ranging from asymptomatic alterations in coagulation test results (e.g., PT, PTT) to severe bleeding or thrombosis (rarely fatal); may be related to antibody formation.100 103 105 106 108 109 110 111 112 (See Antibody Formation under Cautions.)

Consult an expert in coagulation disorders if patient exhibits abnormal coagulation test results, bleeding, or thrombosis.100 Consider underlying immunologic mechanisms with any contemplated intervention.100 106

Sensitivity Reactions

Anaphylaxis with profound bradycardia and hypotension reported rarely.101 b

Potential allergic reactions in patients sensitive to bovine materials.100

Can stimulate antibody formation against bovine thrombin and/or bovine factor V (a potential contaminant in some bovine thrombin preparations).100 103 104 105 106 109 110 111 112 Such antibodies may cross-react with human factor V, potentially resulting in a factor V deficiency and hemorrhagic complications; paradoxical thrombosis also has occurred.100 103 105 106 107 109 111 112 (See Effects on Hemostasis under Cautions.) Antibodies may develop as early as 8 days after use and may persist for months to years following initial exposure.103 105 106 111 Not known whether highly purified preparations (i.e., containing no detectable levels of factor Va) are associated with reduced risk of immunogenicity.100 109

Patients with evidence of anti-bovine thrombin antibodies should not be reexposed to the drug; increased likelihood of antibody formation with repeated application.100 103 104 105 106 107 109 111

General Precautions

Consult prescribing information for absorbable gelatin sponge preparations when used concomitantly.100

Specific Populations

Category C.100

Safety and efficacy not established.100

• Causes clotting of whole blood or plasma without the addition of other substances.100 b Affects hemostasis principally by converting fibrinogen to fibrin; several other mechanisms (e.g., stimulation of platelet release reaction, aggregation of platelets) may be involved.100 109 b

• Rate of blood clotting depends on concentration of thrombin and fibrinogen.100 b

• Does not clot blood when clotting defect is the rare absence of fibrinogen.100

• Importance of informing clinician of allergy to bovine materials. (See Cautions.)100

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.100

• Importance of informing patients of other important precautionary information.100 (See Cautions.)

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Fever.
• A fast heartbeat.