What is Voncento - coagulation factor VIII and von Willebrand factor used for?
Voncento is a medicine containing two active substances, human coagulation factor VIII and the human von Willebrand factor . It is indicated in the treatment and prevention of surgical bleeding in patients with von Willebrand's disease (an inherited disorder characterized by bleeding and caused by a von Willebrand factor deficiency) when treatment with another desmopressin medicine is ineffective or contraindicated. It can also be used in the treatment of bleeding, in preventing surgical bleeding and in the long-term prevention of bleeding in patients with haemophilia A (an inherited disorder characterized by bleeding and caused by the lack of factor VIII).
How is Voncento - coagulation factor VIII and von Willebrand factor used?
Voncento is available as a powder and solvent which, when mixed, form a solution for injection or infusion (drip into a vein). It can only be obtained with a prescription and treatment must be supervised by a doctor experienced in treating disorders bleeding. Voncento is given by injection or slow infusion into a vein (at a maximum rate of 6 ml per minute). In the event of an undesirable effect during injection / infusion, it may be necessary to reduce the speed or stop the administration.
The dose and duration of treatment change depending on whether Voncento is used to treat or prevent bleeding and that it is used in patients with haemophilia A or von Willebrand's disease. The dose and duration of treatment also depend on the severity of the disease, its size and location, the patient's clinical condition and body weight. More details on how to calculate the doses are available in the summary of product characteristics (also included with the EPAR). If the attending physician deems it appropriate, the treatment can be administered at home by the patients themselves or by those who take care of them, after appropriate training. For more information, see the package leaflet.
How does Voncento - coagulation factor VIII and von Willebrand factor work?
The active ingredients in Voncento, human coagulation factor VIII and human von Willebrand factor, are coagulation factors (substances that promote blood clotting). Patients with haemophilia A have a factor VIII deficiency, while subjects with von Willebrand disease have insufficient levels of von Willebrand factor. Both of these conditions lead to coagulation problems, resulting in bleeding in the joints, muscles or internal organs. Voncento is used to replace missing coagulation factors, ensuring a temporary control of the bleeding disorder.
What benefit has Voncento - coagulation factor VIII and von Willebrand factor shown during the studies?
Voncento has been studied in one main study involving 21 patients with von Willebrand's disease to assess their effectiveness in arresting minor bleeding episodes. Patients who had been previously treated with desmopressin or von Willebrand factor were treated with Voncento for 12 months; Voncento was not compared to another therapy. The effectiveness of Voncento in stopping the bleeding was measured using a 4-point scale (from excellent to no result). In addition, the study examined the number of blood transfusions needed and the volume of blood lost during surgery, comparing this data with the blood loss expected by a patient not suffering from bleeding disorders. The effects of Voncento were excellent in about 92% (371 out of 405) of bleeding episodes and good in about 7% (27 out of 405) of bleeding episodes. In the 4 surgeries performed during the study the blood loss was not higher than expected. In one patient it was necessary to proceed with the transfusion. The benefits of Voncento in the prevention and treatment of bleeding episodes in hemophilia A have been demonstrated in a study involving 81 patients previously treated with human coagulation factor VIII. In this study, if used to treat bleeding, Voncento was excellent in 60.4% (396 out of 656) of bleeding episodes and good in 36.0% (236 out of 656) of bleeding episodes. Similar results were observed when Voncento was used as a preventive measure. Among the 37 surgeries performed during the study, 12 of which were challenging, the bleeding was higher than expected in only one case. A total of five patients, all undergoing major knee surgery, needed a blood transfusion.
What is the risk associated with Voncento - coagulation factor VIII and von Willebrand factor?
Side effects of Voncento (which may affect less than 1 in 10 000 people) have been reported rarely and include hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in blood vessels), pyrexia (fever), headache, dysgeusia (disorders of the sense of taste) and abnormal blood levels of liver enzymes. Furthermore, patients may develop antibodies against factor VIII and von Willebrand factor. For the full list of all side effects reported with Voncento, see the package leaflet.
Why has Voncento - coagulation factor VIII and von Willebrand factor been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Voncento's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Voncento was effective in preventing bleeding episodes in patients with haemophilia A and in stopping bleeding in patients with von Willebrand's disease. When bleeding episodes were observed in subjects with haemophilia A treated with Voncento, Voncento made it possible to manage these episodes effectively. Voncento was also effective in the prevention and treatment of bleeding during surgery. As for its safety, side effects have generally been mild to moderate and are considered typical for this kind of medicine.
What measures are being taken to ensure the safe and effective use of Voncento - coagulation factor VIII and von Willebrand factor?
A risk management plan has been developed to ensure that Voncento is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and the package leaflet of Voncento, including the appropriate precautions to be followed by healthcare professionals and patients. Furthermore, the company that makes Voncento will carry out further studies on the efficacy and safety of Voncento in patients with haemophilia A and von Willebrand's disease.
Other information on Voncento - coagulation factor VIII and von Willebrand factor
On 12 August 2013, the European Commission issued a marketing authorization for Voncento, valid throughout the European Union. For more information on Voncento therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2013.
