This is a summary of the European public assessment report (EPAR) for Edurant. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Edurant.
What is Edurant?
Edurant is a medicine that contains the active substance rilpivirine. It is available as tablets (25 mg).
What is Edurant used for?
Edurant is used in combination with other antiviral medicines to treat adults and adolescents from the age of 12 years who are infected with human immunodeficiency virus type 1
The medicine can only be obtained with a prescription.
How is Edurant used?
Treatment with Edurant should be started by a doctor experienced in treating HIV infection. The recommended dose of Edurant is one tablet once a day. If Edurant is given together with rifabutin, the doctor should increase the dose of Edurant to two tablets once a day during rifabutin treatment. Edurant must be taken with a meal.
How does Edurant work?
Edurant is an antiviral medicine. The active substance in Edurant, rilpivirine, is a
How has Edurant been studied?
Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with
In all studies, the main measure of effectiveness was based on the reduction in viral load. Patients who attained a viral load of less than 50
What benefit has Edurant shown during the studies?
- Eviplera - emtricitabine / rilpivirine hydrochloride /tenofovir disoproxil fumarate
- Odefsey - emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide
Prescription drugs listed. Substance: "Rilpivirine hydrochloride"
In adults, Edurant in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of
What is the risk associated with Edurant?
The most frequent side effects with Edurant (seen in more than 1 patient in 10) are headache, insomnia, dizziness, nausea (feeling sick), and increased levels of total cholesterol,
Edurant must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Edurant:
•carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
•rifampicin, rifapentine (antibiotics);
•omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
•systemic dexamethasone (a steroid
•St John’s wort (a herbal antidepressant medicine).
For the full list of restrictions, see the package leaflet.
Why has Edurant been approved?
The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the
What measures are being taken to ensure the safe and effective use of Edurant?
A risk management plan has been developed to ensure that Edurant is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edurant, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Edurant
The European Commission granted a marketing authorisation valid throughout the European Union for Edurant on 28 November 2011.
The full EPAR for Edurant can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Edurant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in