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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/187384/2016

EMEA/H/C/000505

EPAR summary for the public

TachoSil

fibrinogen / thrombin

This is a summary of the European public assessment report (EPAR) for TachoSil. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for TachoSil.

What is TachoSil?

TachoSil is a sealant patch coated with the active substances human fibrinogen and human thrombin.

What is TachoSil used for?

TachoSil is used in adults:

•    during an operation, to stop bleeding and to seal the surfaces of internal organs;

•    as support to stitching during surgery on the blood vessels;

•    during neurological surgery to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).

TachoSil is used when standard techniques are not sufficient.

How is TachoSil used?

TachoSil should only be used by an experienced surgeon.

TachoSil should only be applied directly onto the treatment site so that it covers 1 to 2 cm beyond the edge of the wound. The amount of TachoSil to be used depends on the size of the wound and the material can be cut to size if needed. TachoSil must not be applied inside a blood vessel.

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

How does TachoSil work?

The active substances in TachoSil, fibrinogen and thrombin, are proteins extracted from blood, which are involved in the natural clotting process. Thrombin works by converting fibrinogen into smaller units called fibrin, which then stick together to form a local clot.

When TachoSil is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of a clot. The clot enables the patch to stick more firmly to the tissue, helping to stop the bleeding and sealing the wound.

In neurological surgery, it works by sealing together the cut areas of the outermost layer (dura mater) of the membranes around the brain. This way it prevents the cerebrospinal fluid from leaking.

The TachoSil patch is left in the body, where it dissolves and disappears completely.

How has TachoSil been studied?

TachoSil has been studied in seven studies:

•    Two of the studies looked at the effects of TachoSil in stopping bleeding. The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in a total of 240 adults having liver surgery. The main measure of effectiveness was the time until the bleeding stopped. A third study compared TachoSil with standard stitching in 185 patients having kidney surgery.

•    Two studies were carried out to see if TachoSil could be used as a tissue sealant. The studies compared TachoSil and standard surgical techniques, such as stitching and stapling, in a total of 490 patients having lung surgery. Effectiveness was measured by looking at whether air leaked from the lungs after surgery.

•    A sixth study looked at the effectiveness of TachoSil in surgery on the heart or major blood vessels. The study compared TachoSil with standard materials in 120 patients, of whom around three-quarters also had surgery on vessels with stitches and one-quarter had surgery on the heart. The main measure of effectiveness was the number of patients whose bleeding had stopped after three minutes.

•    Another study in 726 patients compared TachoSil with current techniques used in daily practice in preventing CSF leakage during neurological surgery.

What benefit has TachoSil shown during the studies?

TachoSil was more effective than the argon beamer at stopping bleeding during liver surgery. In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively. TachoSil was more effective than stitching in the kidney surgery patients.

The first study looking at lung surgery patients was not sufficient to support the use of TachoSil in sealing tissue since very few patients in the study had any air leakage. However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with current techniques.

TachoSil was also more effective than standard materials at stopping bleeding during surgery on the heart or blood vessels. After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).

TachoSil

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In the study in neurological surgery, TachoSil was comparable to current techniques: around 7% (25 out of 361) of patients treated with TachoSil had a leak of CSF, compared with around 8% (30 out of 365) of patients on current techniques.

What is the risk associated with TachoSil?

Thromboembolic complications (blood clots in vessels) may occur if TachoSil is applied inside a blood vessel. Like other sealants, TachoSil may cause an allergic reaction. Patients may also develop antibodies to the proteins in TachoSil, which could interfere with blood clotting.

For the full list of all side effects and restrictions with TachoSil, see the package leaflet.

Why has TachoSil been approved?

The CHMP decided that TachoSil's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of TachoSil?

A risk management plan has been developed to ensure that TachoSil is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for TachoSil, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about TachoSil

The European Commission granted a marketing authorisation valid throughout the European Union for TachoSil on 8 June 2004.

The full EPAR for TachoSil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with TachoSil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 03-2016.

TachoSil

EMA/187384/2016