What is Vihuma - Simoctocog alfa used for and what is it used for?
Vihuma is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by a factor VIII deficiency). It contains the active substance simoctocog alfa.
This medicine is the same as Nuwiq, already authorized in the European Union (EU). The Nuwiq manufacturer has agreed that its scientific data may be used for Vihuma ("informed consent").
How is Vihuma used - Simoctocog alfa?
Vihuma can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating haemophilia.
Vihuma is available as a powder and solvent which, when mixed, form a solution for injection into a vein. The dose and frequency of therapy vary depending on whether the medicine is used to treat or prevent bleeding and depend on the severity of the haemophilia, the extent and location of the bleeding, as well as on the patient's health and weight . For more information, see the summary of product characteristics (included with EPAR).
Patients or their caregivers can be given or given Vihuma at home after receiving appropriate instructions. For more information, read the package leaflet.
How does Vihuma - Simoctocog alfa work?
In patients with haemophilia A, factor VIII, a protein necessary for normal blood coagulation, is absent; this deficit causes coagulative problems including bleeding from joints, muscles or internal organs. The active substance in Vihuma, simoctocog alfa, works in the body in the same way as the human factor VIII. It replaces the missing factor VIII, favoring blood coagulation and ensuring a temporary control of the coagulation disorder.
What benefit has Vihuma - Simoctocog alfa shown during the studies?
Vihuma has been shown to be effective in preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
During the first study conducted on 22 patients from the age of 12, who received Vihuma for the treatment of bleeding episodes or for the prevention of bleeding during surgery, 986 bleeding events were recorded, the majority of which which resolved with an injection of Vihuma. The main measure of effectiveness was the judgment of patients on the effectiveness of the treatment. Treatment with Vihuma was rated "excellent" or "good" in 94% of bleeding episodes. In the two surgical operations performed during the study, Vihuma therapy was judged "excellent" in preventing bleeding episodes.
During the second study conducted on 32 patients from 12 years of age, Vihuma was used to prevent and treat bleeding events and to prevent bleeding during surgery. In subjects treated for the prevention of haemorrhage, an average of 0.19 bleeding episodes per month were recorded for each patient. In subjects treated for the management of bleeding episodes, Vihuma was judged to be mostly "excellent" or "good" in the treatment of major bleeding episodes, most of which resolved after one or more administrations of Vihuma. In the five surgeries performed during the study, Vihuma was judged as "excellent" in preventing bleeding episodes in four operations and "moderate" in preventing bleeding in the fifth surgery.
The third study was conducted on 59 children aged between 2 and 12 years. In subjects treated to prevent bleeding, an average of 0.34 bleeding episodes per month were recorded for each patient. When the medicine was used to manage bleeding episodes, these resolved in 81% of cases after one or two injections of Vihuma.
What are the risks associated with Vihuma - Simoctocog alfa?
The side effects of Vihuma have only been reported occasionally (and affected 1-10 people in 1 000). Among these undesirable effects there are paraesthesia (abnormal sensations such as tingling), headache, vertigo (sensation of rotation of the surrounding environment), dry mouth, back pain and inflammation and pain at the injection site.
Hypersensitivity (allergic) reactions, although they have never been observed so far in subjects treated with Vihuma, have been rarely reported with factor VIII products and, in some cases, they can evolve into serious allergic reactions. After treatment with factor VIII products, some patients may develop factor VIII inhibitors, or antibodies (proteins) that the body's immune system produces against factor VIII and which render the medicine ineffective, resulting in a loss of control over the 'hemorrhage. In these cases it is recommended to contact a center specialized in the treatment of haemophilia.
For the full list of restrictions and side effects reported with Vihuma, see the package leaflet.
Why has Vihuma - Simoctocog alfa been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vihuma's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Vihuma has been shown to be effective in the treatment and prevention of bleeding episodes in patients with haemophilia A. Vihuma has also been effective in preventing and treating bleeding after bleeding after surgery, with similar effects to other factor VIII products. The safety profile of Vihuma was also considered similar to that of other factor VIII products.
What measures are being taken to ensure the safe and effective use of Vihuma - Simoctocog alfa?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vihuma have been included in the summary of product characteristics and the package leaflet.
More information about Vihuma - Simoctocog alfa
On 13 February 2017, the European Commission issued a marketing authorization for Vihuma, valid throughout the European Union.
The full EPAR for Vihuma is available on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Vihuma therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 01-2017.
