Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Evarrest Sealant Matrix.
The indication recommended by the CHMP is as follows: Evarrest is indicated in adults for supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.
Evarrest should only be prescribed by experienced surgeons.
The active substances of Evarrest are human Fibrinogen and human Thrombin, substances that together help to form a blood clot. They are in a dried form coating the surface of an absorbable composite material ( Sealant Matrix ). Upon contact with a bleeding wound surface, the fibrinogen and thrombin become activated and form a clot that helps to stop bleeding ( haemostasis ) and seal the wound.
The CHMP decided that the benefits of Evarrest are greater than its risks following assessment of three main studies that demonstrated haemostasis in soft tissue bleeding in patients undergoing abdominal, retroperitoneal, pelvic or thoracic surgery and also in parenchymal bleeding in patients undergoing hepatic surgery.
The most common adverse reactions reported during clinical trials ( greater than or equal to 1% ) were abdominal distension, blood fibrinogen increased, post procedural and intra-abdominal hemorrhage, and pulmonary embolism.
Do not use Evarrest for: bleeding from large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of Evarrest to blood flow and/or pressure during absorption of the product; intravascular application ( this can result in life-threatening thromboembolic events ); individuals known to have anaphylactic or severe systemic reaction to human blood products. ( Xagena )
Source: EMA, 2013
XagenaMedicine_2013
