Elocta
Authorised
This medicine is authorised for use in the European Union
efmoroctocog alfa
MedicineHumanAuthorised
Overview
Elocta is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance efmoroctocog alfa.
Elocta is available as a powder and solvent used to make a solution for injection. The injection is given into a vein over several minutes. The dose and frequency of the injections depend on whether Elocta is used to treat or prevent bleeding, the severity of the patient’s factor VIII deficiency, the extent and location of the bleeding and the patient’s condition and bodyweight.
Elocta 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. For more information about using Elocta, see the package leaflet or contact your doctor or pharmacist.
Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Elocta, efmoroctocog 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 bleeding.
Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Elocta, efmoroctocog 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 bleeding.
Two main studies of Elocta showed that the medicine is effective at both preventing and treating bleeding episodes.
In a study of 165 adult patients with haemophilia A, patients who were given Elocta as a tailored preventive treatment had around 3 bleeding episodes a year, which compares with 37 episodes a year in patients not given preventive treatment. In addition, when bleeding did occur, Elocta treatment was rated as ‘excellent’ or ‘good’ in more than 78% of cases, with 87% of bleeding episodes resolving with only one injection.
In a study in 69 children, Elocta was similarly effective: 2 bleeding episodes occurred per year on average and 81% of bleeding episodes resolved with only one injection.
Hypersensitivity (allergic) reactions are seen rarely with Elocta and these include: swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the injection site, chills, flushing, itching over the whole body, headache, low blood pressure, lethargy, nausea, restlessness, and a fast heartbeat. In some cases these reactions can become severe.
There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
For the full list of side effects and restrictions of Elocta, see the package leaflet.
Studies show that Elocta is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is in line with what is expected for medicines of its kind. The European Medicines Agency therefore decided that Elocta’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elocta have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Elocta are continuously monitored. Side effects reported with Elocta are carefully evaluated and any necessary action taken to protect patients.
Elocta received a marketing authorisation valid throughout the EU on 19 November 2015.
Product information
Latest procedure affecting product information: II/0039
11/01/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Elocta
- Active substance
- efmoroctocog alfa
- International non-proprietary name (INN) or common name
- efmoroctocog alfa
- Therapeutic area (MeSH)
- Hemophilia A
- Anatomical therapeutic chemical (ATC) code
- B02BD02
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Elocta can be used for all age groups.
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