2% of patients treated with comparator treatments. 0% of comparator treated patients. Rarely, hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in patients treated with fibrin sealants/ hemostatics.
In isolated cases, these reactions may progress to severe anaphylaxis. Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Antibodies against components of fibrin sealant/hemostatic products may occur rarely. The equine collagen antibodies that developed in some patients after TachoSil® use were not reactive with human collagen. One patient developed antibodies to human fibrinogen.
There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies. There is very limited clinical data available regarding re-exposure of TachoSil®. Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of TachoSil® has been evaluated in six controlled clinical trials, in which 521 patients were treated with TachoSil® and 511 patients were treated with comparator treatment.
Due to practical reasons (comparison to standard surgical and standard hemostatic treatment), blinding was not possible in the TachoSil® trials. Therefore, the studies were performed as open-label studies. 0% of comparator treated patients.
1 - 94 years of age) to collect information, following exposure to TachoSil®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. The TachoSil®, Absorbable fibrin sealant patch Page 9 of 18 trial was designed as an international, non- interventional, prospective, single cohort trial of the use of TachoSil® in supportive treatment in surgery for improvement of hemostasis where standard techniques are insufficient.
3% had risk factors for immunological events). 3% of patients had at least one thromboembolic, major bleeding, or immunological event, respectively. No cases were reported where an investigator suspected an interaction with concomitant medication as responsible for an adverse event.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings This information is not available for this drug product. Post-Market Findings This information is not available for this drug product.
5 Post-Market Adverse Reactions The following adverse drug reactions have been reported in post-marketing experience: Immune disorders: Anaphylactic shock, hypersensitivity Gastrointestinal disorders: Intestinal obstruction (in abdominal surgeries), ileus (in abdominal surgeries) General disorders and administration site conditions: Adhesions, Drug ineffective Vascular disorders: Thrombosis TachoSil®, Absorbable fibrin sealant patch Page 1 of 33 Because post-marketing reporting of adverse reaction is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.