Tisseel Adverse Reactions

Hypersensitivity or allergic reactions (which may include but are not limited to angioedema, burning and stinging at the application site, bradycardia, bronchospasm, chills, breathing difficulties, transient erythema ("flushing"), generalized urticaria, headache, hives, hypotension, lethargy, nausea, pruritus, restlessness, paresthesia, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/hemostatics, anaphylactic reactions and anaphylactic shock have included fatal outcomes.
In isolated cases, these reactions have progressed to severe anaphylaxis. Such reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to aprotinin (see Precautions) or any other constituents of the product.
Even if repeated treatment with TISSEEL Fibrin Sealant with Synthetic Aprotinin was well tolerated, a subsequent administration of TISSEEL Fibrin Sealant with Synthetic Aprotinin or systemic administration of aprotinin may result in severe anaphylactic reactions.
Antibodies against components of the fibrin sealant/hemostatic may occur in rare cases.
Inadvertent intravascular injection may result in thromboembolic events and DIC.
Furthermore, there is the risk of an anaphylactic reaction (see Precautions).
For safety with respect to transmissible agents, see Precautions.
The adverse reactions presented in this monograph were reported from clinical trials investigating the safety and efficacy of TISSEEL Fibrin Sealant with Synthetic Aprotinin and from post-marketing experience (marked with a ^p in the adverse event table as follows) with Baxter Fibrin Sealants. In the clinical trials, TISSEEL Fibrin Sealant with Synthetic Aprotinin was administered for adjunct hemostasis in cardiac, vascular, and total hip replacement surgeries and in liver and spleen surgeries. Other clinical trials included the sealing of lymphatic vessels in patients undergoing axillary lymph node dissection, sealing of colonic anastomosis and in dural sealing in the posterior fossa. As the frequencies of adverse events observed in post-marketing experience cannot be calculated, whenever possible, the upper limit of the 95% confidence interval was calculated using the "rule of three" in the following manner: 3/1146=0.0026 or 0.26% which is "Uncommon" (where "1146" is the total number of subjects to have received TISSEEL Fibrin Sealant with Synthetic Aprotinin in the clinical trials from which data were included in the monograph).
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). (See Table 2.)

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Class Reactions: Other adverse reactions associated with the fibrin sealant/hemostatic class include: manifestations of hypersensitivity include application site irritation, chest discomfort, chills, headache, lethargy, restlessness, and vomiting.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.