EPAR summary for the public
This document is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
What is Yentreve?
Yentreve is a medicine containing the active substance duloxetine. It is available as blue (20 mg) and orange (40 mg) capsules.
What is Yentreve used for?
Yentreve is used to treat moderate to severe stress urinary incontinence (SUI) in women. SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising.
The medicine can only be obtained with a prescription.
How is Yentreve used?
The recommended dose of Yentreve is 40 mg twice a day. Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness. The benefit of treatment should be
How does Yentreve work?
The active substance in Yentreve, duloxetine, is a
How has Yentreve been studied?
Yentreve has been studied in a total of 2,850 women with SUI. The four main studies involved 1,913 women and lasted 12 weeks, comparing Yentreve (mostly as 40 mg twice daily) with placebo (a
dummy treatment). The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients’ scores on an
What benefit has Yentreve shown during the studies?
In all four studies, the patients treated with Yentreve had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study. The IEF decreased by 52% in the Yentreve group, compared with a decrease of 33% in the
What is the risk associated with Yentreve?
The most common side effects with Yentreve (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness). For the full list of all side effects reported with Yentreve, see the Package Leaflet.
Yentreve should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients. Yentreve should not be used in patients with certain types of liver disease or with severe kidney disease. Yentreve should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic). Treatment with Yentreve should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Why has Yentreve been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Yentreve’s benefits are greater than its risks for the treatment of moderate to severe SUI. The Committee recommended that Yentreve be given marketing authorisation.
Other information about Yentreve:
The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B.V. on 11 August 2004.
The full EPAR for Yentreve is available here.
This summary was last updated in