HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TACHOSIL safely and effectively. See full prescribing information for TACHOSIL.
TACHOSIL ® Fibrin Sealant Patch
Absorbable Patch for Topical Use
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
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Indications and Usage (1)
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7/2015
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Dosage and Administration (2)
Dosage and Administration, Method of Application (2.2)
Dosage and Administration, Retreatment (2.3)
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7/2015
7/2015
7/2015
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Warnings and Precautions, Thrombosis (5.1)
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7/2015
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INDICATIONS AND USAGE
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. (1)
Limitations for TachoSil Use
Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. (1)
Not for use in children under one month of age. (8.4)
DOSAGE AND ADMINISTRATION
Apply on the surface of cardiovascular or hepatic tissue only.
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Determine the number of TachoSil patches to be applied by the size of the bleeding area. ( 2)
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Apply the yellow, active side of the patch to the bleeding surface. ( 2)
DOSAGE FORMS AND STRENGTHS
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TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
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Each absorbable patch contains, per square inch (inch 2): human fibrinogen 23.2 to 47.7 mg (35.5 mg); human thrombin 8.4 to 17.4 Units (12.9 U) per cm 2: human fibrinogen 3.6 to 7.4 mg (5.5 mg); human thrombin 1.3 to 2.7 Units (2.0 U). ( 3)
CONTRAINDICATIONS
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Do not apply TachoSil intravascularly. Intravascular application of TachoSil may result in life-threatening thromboembolic events. ( 4)
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Do not use TachoSil in individuals with known hypersensitivity to human blood products or horse proteins. ( 4)
WARNINGS AND PRECAUTIONS
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Thrombosis can occur if TachoSil is applied intravascularly. Ensure that TachoSil is applied to the surface of cardiac, vascular or hepatic tissue only. ( 5.1)
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Can cause hypersensitivity or allergic/anaphylactoid reactions with first time or repetitive application. ( 5.2)
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Avoid use in contaminated areas of the body or in the presence of an active infection. ( 5.3)
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TachoSil contains collagen, which may adhere to bleeding surfaces. ( 5.4)
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Avoid over-packing in cavities or closed spaces, because this may cause compression of underlying tissue. ( 5.5)
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Use the least number of patches required to cover the entire bleeding area. Do not pack. Remove any unattached pieces of TachoSil. ( 5.6)
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May carry a risk of transmitting infectious agents, such as viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent, and the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission. ( 5.7)
ADVERSE REACTIONS
The most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection and post-procedural bile leakage in hepatic surgery. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: No human or animal data. Use only if clearly needed. (8.1)
Pediatric: Use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as recommended. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
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