What is Vihuma - Simoctocog alfa 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, which is already authorized in the European Union (EU). The company that makes Nuwiq has agreed that its scientific data can be used for Vihuma (“informed consent”).
How is Vihuma - Simoctocog alfa used?
Vihuma can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of 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 according to 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 the patient's health and weight. . For more information, see the Summary of Product Characteristics (included in the EPAR).
Patients or their carers can administer or have Vihuma administered at home after receiving appropriate instructions. For more information, read the package leaflet.
How does Vihuma - Simoctocog alfa work?
Factor VIII, a protein necessary for normal blood clotting, is absent in patients with haemophilia A; this deficiency causes clotting problems including haemorrhages affecting joints, muscles or internal organs. The active substance in Vihuma, simoctocog alfa, works in the body in the same way as human factor VIII. It replaces the missing factor VIII, helping blood to clot and providing temporary control of the bleeding 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 involving 22 patients from 12 years of age who had been given Vihuma for the treatment of bleeding episodes or for the prevention of bleeding during surgery, 986 bleeding events were recorded, the majority of which was resolved with an injection of Vihuma. The main measure of efficacy was the patients' judgment of the efficacy of the treatment. Vihuma treatment was rated "excellent" or "good" in 94% of bleeding episodes. In the two surgeries performed during the study, Vihuma therapy was rated "excellent" in preventing bleeding episodes.
During the second study involving 32 patients from 12 years of age, Vihuma was used to prevent and treat bleeding events and to prevent bleeding during surgery. on average 0.19 bleeding episodes per month for each patient. In subjects treated for the management of bleeding episodes, Vihuma was mostly rated as "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 rated "excellent" in preventing bleeding in four surgeries and "moderate" in preventing bleeding in the fifth surgery.
The third study involved 59 children between the ages of 2 and 12. 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 Vihuma injections.
What are the risks associated with Vihuma - Simoctocog alfa?
Side effects with Vihuma have only been reported occasionally (affecting 1 to 10 in 1,000 people). These side effects include paraesthesia (abnormal sensations such as tingling), headache, dizziness (sensation of rotation of the surrounding environment), dry mouth, back pain and inflammation and pain at the injection site.
Hypersensitivity (allergic) reactions, although never seen so far in subjects treated with Vihuma, have rarely been reported with factor VIII products and, in some cases, can develop into severe allergic reactions. After treatment with factor VIII products, some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system makes against factor VIII and which make the medicine ineffective, resulting in a loss of control over the "hemorrhage. In these cases it is recommended to go to 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 treatment and prevention of bleeding episodes in patients with haemophilia A. Vihuma was also effective in preventing and treating bleeding from bleeding episodes that occurred after surgery, with effects similar to other factor VIII products. The safety profile of Vihuma was also considered to be similar to that of other factor VIII products.
What measures are being taken to ensure the safe and effective use of Vihuma - Simoctocog alfa?
The recommendations and precautions that healthcare professionals and patients need to observe in order for Vihuma to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
Other information about Vihuma - Simoctocog alfa
On 13 February 2017, the European Commission issued a "Marketing Authorization" for Vihuma, valid throughout the European Union.
For the full version of Vihuma's EPAR, please consult 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 (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 01-2017.
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