Jivi
Authorised
This medicine is authorised for use in the European Union
damoctocog alfa pegol
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Jivi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII. Jivi can be used in adults and children from 12 years of age who have been treated previously.
Jivi contains the active substance damoctocog alfa pegol.
Jivi is given by 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 severity of the haemophilia, the extent and location of the bleeding and the patient’s condition and weight. Patients or their carers may be able to inject Jivi themselves at home once they have been trained appropriately.
Jivi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia. For more information about using Jivi, see the package leaflet or contact your doctor or pharmacist.
Patients with haemophilia A lack factor VIII, a protein needed for blood to clot and, as a result, they bleed readily. The active substance in Jivi, damoctocog alfa pegol, works in the same way as the body’s factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Part of the active substance is a substance called polyethylene glycol, ‘PEG’, which is included to help the medicine remain in the body for longer and thereby prolong its action.
Jivi has been shown to be effective at reducing the number of bleeding episodes in patients with severe haemophilia and stopping bleeding when it occurs.
In a study of 134 patients from 12 years of age, 114 patients given Jivi as a preventive treatment had around 2 bleeding episodes per year. The 20 patients who were given Jivi for treating bleeding when it occurred had around 23 bleeding episodes a year. In a second part of the study, 17 patients received Jivi to control bleeding during 20 major surgeries. Jivi was rated good or excellent at stopping bleeding in all surgeries.
In a second study in 61 children aged below 12 years, Jivi given as preventive treatment reduced the number of bleeding episodes to around 3 episodes a year.
The most common side effect with Jivi (which may affect more than 1 in 10 people) is headache. Hypersensitivity (allergic) reactions are common with Jivi (affecting up to 1 in 10 people) and may include swelling, burning and stinging at the injection site, chills, flushing, tingling, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing. In some cases these reactions can become severe.
Following treatment with factor VIII products, including Jivi, some patients may develop inhibitors (antibodies) against factor VIII, preventing the medicine from working effectively and resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.
Jivi must not be used in patients with allergy to mouse or hamster proteins. For the full list of side effects and restrictions, see the package leaflet.
The European Medicines Agency decided that Jivi’s benefits are greater than its risks and it can be authorised for use in the EU.
Studies show that Jivi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products. However, laboratory studies show that PEG, which is part of the active substance in Jivi, may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment. Since this could potentially cause problems especially in children below 12 years of age, Jivi is only approved for use in adults and children from 12 years of age.
The company that markets Jivi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jivi have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Jivi are continuously monitored. Side effects reported with Jivi are carefully evaluated and any necessary action taken to protect patients.
Jivi received a marketing authorisation valid throughout the EU on 22 November 2018.
Product information
Latest procedure affecting product information:
R/0027
23/06/2023
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
- Jivi
- Active substance
- Damoctocog alfa pegol
- International non-proprietary name (INN) or common name
- damoctocog alfa pegol
- Therapeutic area (MeSH)
- Hemophilia A
- Anatomical therapeutic chemical (ATC) code
- B02BD02
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Treatment and prophylaxis of bleeding in previously treated patients ? 12 years of age with haemophilia A (congenital factor VIII deficiency).
News on Jivi
Topics
This page was last updated on