Yentreve
Authorised
This medicine is authorised for use in the European Union
duloxetine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This 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 its 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).
Yentreve is a medicine containing the active substance duloxetine. It is available as blue (20 mg) and orange (40 mg) capsules.
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.
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 re-assessed at regular intervals. Combining Yentreve with pelvic-floor-muscle training may provide additional benefit.
The active substance in Yentreve, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor (SNRI). It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells. How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage. By closing the urethra more powerfully, Yentreve prevents the unwanted loss of urine during physical stress such as coughing or laughing.
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 incontinence-specific quality-of-life questionnaire (I-QOL).
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 placebo-treated group. The I-QOL questionnaire scores were also improved in the Yentreve group compared with the placebo group. Yentreve was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
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).
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.
The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B.V. on 11 August 2004.
Product information
Latest procedure affecting product information:
PSUSA/00001187/202308
17/06/2024
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
- Yentreve
- Active substance
- duloxetine hydrochloride
- International non-proprietary name (INN) or common name
- duloxetine
- Therapeutic area (MeSH)
- Urinary Incontinence, Stress
- Anatomical therapeutic chemical (ATC) code
- N06AX21
Pharmacotherapeutic group
PsychoanalepticsTherapeutic indication
Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
Topics
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