What is Raplixa - Human Fibrinogen / Human Thrombin and what is it used for?
Raplixa is a medicine used in adults during surgery to help stop bleeding if the standard surgical techniques for bleeding control, such as suturing, are insufficient. Raplixa contains the active human fibrinogen and human thrombin. It must be used with an approved gelatin sponge.
How is Raplixa - Human Fibrinogen / Human Thrombin used?
Raplixa should only be used by experienced surgeons and can only be obtained with a prescription. Raplixa is available in powder form (0.5, 1 and 2 g). The amount of Raplixa to be applied and the frequency of application depend on the needs of the patient and on variables such as the type of surgery, the size of the wound and the severity of the bleeding. A thin layer of powder can be applied directly to the bleeding site from the vial or by a nebulizer, then covering the treated surface with a gelatin sponge. Alternatively, the powder can be applied to the moistened gelatin sponge, immediately before application on the bleeding site. For more information, see the summary of product characteristics.
How does Raplixa - human fibrinogen / human thrombin work?
The active ingredients of Raplixa, human fibrinogen and human thrombin, are natural blood proteins obtained from blood donors. Once applied to a wet surface, thrombin is activated and breaks fibrinogen into smaller units called fibrins. Subsequently the fibrins aggregate together forming a clot that firmly fixes the gelatin sponge to the affected surface, blocking the bleeding and sealing the tissue. The sponge is left in place, where it dissolves until it disappears completely.
What benefit has Raplixa - Human fibrinogen / Human thrombin shown during the studies?
Raplixa has been shown to be effective in helping to stop bleeding during surgery in a main study involving 721 patients undergoing surgery involving the spine, liver, blood vessels or soft tissues, and in which bleeding occurred that could not be controlled with standard surgical techniques. The study put comparison Raplixa used in combination with the gelatin sponge with the sole use of gelatin sponge. In the various types of surgery, ongoing bleeding in patients in the Raplixa group was stopped within 1-2 minutes compared to the 2-4 minutes needed to stop bleeding in the control group. On average, the use of Raplixa reduced bleeding duration by about 2 minutes.
What is the risk associated with Raplixa - Human Fibrinogen / Human Thrombin?
The most common side effects of Raplixa (which may affect up to 1 in 10 people) are insomnia and itching. Other side effects seen more rarely with this type of medicine are allergic reactions. There has been an air or gas embolism (presence of air or gas in the blood that can compromise blood circulation) potentially fatal with the use of other nebulizers for the administration of fibrin. The risk of embolism is extremely low but cannot be totally excluded with Raplixa. For the full list of all side effects reported with Raplixa, see the Raplixa package insert. It should not be applied intravascularly (inside the blood vessels). It must not be applied with nebulization during an endoscopy (a procedure that involves the use of an optical tube equipped with micro-cameras for the visualization of the organism inside) or a laparoscopy (the execution of a surgical operation through small holes, without opening the abdominal wall). It must not be used as a glue for fixing tissue flaps or as a glue to join parts of the intestine that are far apart (gastrointestinal anastomoses). Finally, it should not be used for the treatment of severe bleeding from the arteries. For the complete list of limitations, see the package insert.
Why has Raplixa - Human Fibrinogen / Human Thrombin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Raplixa's benefits are greater than its risks and recommended that it be approved for use in the EU. The committee is of the opinion that Raplixa is effective in reducing the time needed to stop mild to moderate bleeding when standard surgical techniques, including suturing, are insufficient. Raplixa is a powder available in vials that can be stored at room temperature. Once a vial is opened, the medicine should be used within two hours, which allows it to be applied to multiple bleeding sites. Safety was considered acceptable, provided the agreed measures are taken
What measures are being taken to ensure the safe and effective use of Raplixa - Human Fibrinogen / Human Thrombin?
A risk management plan has been developed to ensure that Raplixa 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 Raplixa, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Raplixa will ensure that all surgeons who use the medicine receive information material on the risk of air or gas embolism and instructions for proper use of the nebulizer. Further information is available in the summary of the risk management plan
Other information on Raplixa - Human fibrinogen / Human thrombin
On 19 March 2015, the European Commission issued a marketing authorization for Raplixa, valid throughout the European Union. For more information about Raplixa therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015.
