This is a summary of the European public assessment report (EPAR) for Vihuma. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vihuma.
For practical information about using Vihuma, patients should read the package leaflet or contact their doctor or pharmacist.
- What is Vihuma and what is it used for?
Vihuma is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance simoctocog alfa.
This medicine is the same as Nuwiq, which is already authorised 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 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 that are mixed together to make a solution for injection into a vein. The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the seriousness of the haemophilia, the extent and location of the bleeding and the patient’s condition and bodyweight. For further information, see the summary of product characteristics (also part of the EPAR).
Patients or their carers may be able to administer Vihuma themselves at home once they have been trained appropriately. For full details, see the package leaflet.
- How does Vihuma work?
Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and this causes blood clotting problems, such as bleeding in the 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, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
- What benefits of Vihuma have been shown in studies?
Vihuma has been shown to be effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
The first study involved 22 patients aged 12 years and above, who were given Vihuma for the treatment of bleeding episodes or to prevent bleeding during surgery. A total of 986 bleeding episodes were recorded, the majority of which resolved with one injection of Vihuma. The main measure of effectiveness was based on patients’ assessment of how well treatment worked. Treatment with Vihuma was rated as ‘excellent’ or ‘good’ for 94% of bleeding episodes. In the two surgeries that occurred during the study, Vihuma was rated as excellent in preventing bleeding episodes.
The second study involved 32 patients aged 12 years and above who were given Vihuma to prevent and treat bleeding events as well as to prevent bleeding during surgery. When used to prevent bleeding, an average of 0.19 bleeds per month was recorded for each patient. When used for the treatment of bleeding episodes, Vihuma was mainly rated as ‘excellent’ or ‘good’ at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Vihuma. In the five surgeries that occurred during the study, Vihuma was rated as excellent in preventing bleeding episodes for four surgeries and as moderate to prevent bleeding during one surgical intervention.
The third study involved 59 children aged two to 12 years. When Vihuma was used to prevent bleeding, an average of 0.34 bleeds per month was recorded for each child. When used for treatment bleeding episodes resolved in 81% of cases following one or two injections with Vihuma.
- What are the risks associated with Vihuma?
Side effects with Vihuma have not been commonly reported (affecting between 1 and 10 in 1,000 people). They include paraesthesia (unusual sensations like pins and needles), headache, vertigo (a spinning sensation), dry mouth, back pain and inflammation and pain at the injection site.
Hypersensitivity (allergic) reactions although not seen so far with Vihuma, have been reported rarely with factor VIII products and may in some cases progress to severe allergic reactions. Following treatment with factor VIII products some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body’s immune system produces against factor VIII and which can cause the medicine to stop working, resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.
For the full list of all side effects and restrictions with Vihuma, see the package leaflet.
- Why is Vihuma 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 at treating and preventing the occurrence of bleeding in patients with haemophilia A. Vihuma was also effective in preventing and treating bleeding in relation to bleeding episodes after surgery, with effects similar to other factor VIII products. The safety profile of Vihuma was also considered similar to other factor VIII products.
- What measures are being taken to ensure the safe and effective use of Vihuma?
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.
- Other information about Vihuma
The European Commission granted a marketing authorisation valid throughout the European Union for Vihuma on 13 February 2017.
For more information about treatment with Vihuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 12/04/2017 .
13/02/2017 Vihuma -EMEA/H/C/004459 --
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Vihuma can be used for all age groups.
Changes since initial authorisation of medicine
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Initial marketing-authorisation documents
This medicine is approved for use in the European Union