Voncento - coagulation factor VIII and von Willebrand factor

What is Voncento and what is it used for - coagulation factor VIII and von Willebrand factor?

Voncento is a medicine containing two active substances, human coagulation factor VIII and human von Willebrand factor. It is indicated for the treatment and prevention of surgical bleeding in patients with von Willebrand disease (an inherited disorder characterized by bleeding and caused by a deficiency of von Willebrand factor) when treatment with another medicine called desmopressin is ineffective or contraindicated. It can also be used in the treatment of bleeding, in the prevention of surgical bleeding and in the long-term prevention of bleeding in patients with haemophilia A (an inherited disease characterized by bleeding and caused by a lack of factor VIII).

How is Voncento used - coagulation factor VIII and von Willebrand factor?

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 should be supervised by a doctor who has experience in treating the disorders. bleeding. Voncento is given by injection or slow infusion into a vein (at a maximum rate of 6 ml per minute). If an undesirable effect occurs during the injection / infusion, the rate may need to be reduced or the administration stopped.

The dose and duration of treatment vary depending on whether Voncento is used to treat or prevent bleeding and whether 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 in the EPAR). If the treating physician deems it appropriate, the treatment can be administered at home by the patients themselves or by their carers, after proper training, for further information, see the package leaflet.

How does Voncento work - coagulation factor VIII and von Willebrand factor?

The active substances in Voncento, human coagulation factor VIII and human von Willebrand factor, are clotting factors (substances that promote blood clotting). Patients with haemophilia A have factor VIII deficiency, while subjects with von Willebrand disease have insufficient levels of von Willebrand factor. Both of these conditions cause clotting problems, resulting in bleeding in the joints, muscles or internal organs. Voncento is used to replace missing clotting factors, ensuring temporary control of the bleeding disorder.

What benefit has Voncento - coagulation factor VIII and von Willebrand factor shown during the studies?

Voncento was studied in a main study involving 21 patients with von Willebrand disease to evaluate its effectiveness in arresting minor bleeding episodes. Patients who had previously been treated with desmopressin or von Willebrand factor were treated with Voncento for 12 months; Voncento was not compared with any "other therapy." Voncento's effectiveness in "stopping" bleeding was measured on a 4-point scale (excellent to no result). In addition, the study looked at the number of blood transfusions needed and the volume of blood lost during surgery, comparing this to the expected blood loss from a patient without bleeding disorders. The effects of Voncento were excellent. in about 92% (371 out of 405) of the bleeding episodes and good in about 7% (27 out of 405) of the bleeding episodes. In the 4 surgeries performed during the study, 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 haemophilia A were demonstrated in a study involving 81 patients previously treated with human coagulation factor VIII. In this study, when 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 seen. when Voncento was used for preventive purposes. Of the 37 surgeries performed in the study, 12 of which were challenging, bleeding was higher than expected in only one case. In total five patients, all undergoing major surgery knee surgery, they needed a blood transfusion.

What is the risk associated with Voncento - coagulation factor VIII and von Willebrand factor?

Side effects with Voncento (which may affect less than 1 in 10,000 people) have been reported infrequently and include hypersensitivity (allergic) reactions, thromboembolic events (problems due to blood clots forming), pyrexia (fever), headache , dysgeusia (disturbances in the sense of taste) and abnormal blood levels of liver enzymes. In addition, patients can develop antibodies to factor VIII and von Willebrand factor. For the full list of 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 found to be effective in preventing bleeding episodes in patients with haemophilia A and in "arresting" bleeding in patients with von Willebrand's disease. When bleeding episodes were observed in patients with haemophilia A treated with Voncento preventively, Voncento enabled these episodes to be managed effectively. Voncento was also effective in preventing and treating bleeding during surgery.As to its safety, side effects were generally mild to moderate and are considered typical for this type 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 package leaflet for Voncento, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, 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.

More information about 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 (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 08-2013.


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