Important Risk Information for TISSEEL
For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events. Caution should be exercised to minimize the risk of inadvertent intravascular application in cardiopulmonary bypass surgeries.
Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.
Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.
Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.
Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.
Air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants. This event appears to be related to use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.
When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.
Exposure to solutions containing alcohol, iodine or heavy metals may cause TISSEEL to be denatured. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.
Apply TISSEEL as a thin layer. Excess clot thickness may delay the natural wound healing process.
The safety and effectiveness of the combined use of TISSEEL with other biocompatible materials has not been evaluated in controlled clinical trials. The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.
TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Please see accompanying full Prescribing Information.
