Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The adverse reactions reported in more than one percent 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.
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 Corza Medical GmbH at 1-800-997-1067 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Cardiovascular Surgery In the cardiovascular trial, the most frequently reported adverse reactions were atrial fibrillation and pleural effusion.
Seventy-four percent (74%) of patients treated with TachoSil and 75% of comparator treated patients experienced one or more clinically relevant adverse reactions (see Table 2) .
Most Frequent Adverse Reactions (Cardiovascular Trial) Adverse Reaction TachoSil Comparator Comparator: Hemostatic fleece material without additional active coagulation stimulating compounds.
N = 62 As treated population (safety data set).
n (%) N = 57 n (%) Atrial fibrillation 18 (29%) 14 (25%) Pleural effusion 14 (23%) 11 (19%) Pyrexia 4 (6%) 3 (5%) Hepatic Surgery In the hepatic surgery trial, the most frequently reported adverse reactions were nausea and anemia (see Table 3).
Ninety-four percent (94%) of patients treated with TachoSil and 94% of comparator treated patients experienced one or more clinically relevant adverse reactions.
5 WARNINGS AND PRECAUTIONS • 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 ) • Can cause hypersensitivity or allergic/anaphylactoid reactions with first time or repetitive application.
( 5.2 ) • Avoid use in contaminated areas of the body or in the presence of an active infection.
( 5.3 ) • TachoSil contains collagen, which may adhere to bleeding surfaces.
Like all medications, Tachosil can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: