TachoSil Special Precautions

General: TachoSil is for topical use only. There are no data on repeated application.
Do not use intravascularly. Thromboembolic complications may occur if the preparation is applied intravascularly.
Specific data have not been obtained on the use of this product in neurosurgery after recent radiation therapy or in gastrointestinal anastomotic surgery.
TachoSil should not be used for the treatment of severe or brisk arterial bleeding because TachoSil has not been evaluated in this treatment.
TachoSil should not be used in procedures involving the renal pelvis or ureter because it may be a focus for calculus formation.
TachoSil should not be used in the closure of skin incisions since it may interfere with the healing of skin edges or cause wound dehiscence.
Hypersensitivity: Administration of TachoSil may result in allergic reactions in some patients. For patients with a known allergic diathesis or a history of hypersensitivity to protein products, a careful risk-benefit assessment should be carried out prior to administration. The risk of immunisation against proteins is increased if repeated exposure occurs within six months. If it is decided to proceed with treatment in such patients, prior administration of antihistamines should be considered.
Signs of hypersensitivity reactions include urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, the administration must be discontinued immediately. In case of shock, the current medical standards for shock treatment should be observed.
To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of human fibrinogen/human thrombin sealant matrix (see Cautions for Usage). Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
Contaminated Spaces: Do not leave TachoSil in an infected or contaminated space because it may potentiate an existing infection.
Transmissible infectious agents: The active substances of TachoSil are derived from human plasma. Products made from human plasma may contain infectious agents which can cause disease, such as viruses and theoretically Creutzfeld-Jacob Disease (CJD) agents. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include: selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parovirus B19. Parovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
It is therefore strongly recommended that every time TachoSil is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
All infections thought by a clinician possibly to have been transmitted by TachoSil should be reported by the clinician or other health care provider to Takeda.
Patients should be instructed to consult their clinician if symptoms of B19 virus infection appear (fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain).
Effects of Fertility: Studies to determine the effect of TachoSil on fertility have not been performed.
Genotoxicity: Studies to determine the genotoxicity of TachoSil have not been performed.
Carcinogenicity: Long-term animal studies to evaluate the carcinogenic potential of TachoSil have not been performed. An assessment of the carcinogenic potential of TachoSil was completed and demonstrated negligible carcinogenic risk from product use.
Effects of laboratory tests: Interactions with laboratory tests have not been established.
Use in Pregnancy: See USE IN PREGNANCY & LACTATION section for further information.
Use in Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: TachoSil is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.
Use in the Elderly: In clinical trials, no overall differences in the safety or effectiveness of TachoSil were observed in patients over the age of 65, compared to patients 18 to 65 years of age.