What is Yentreve?
Yentreve is a medicine that contains duloxetine as the active substance. It is available as blue (20 mg) or orange (40 mg) capsules.
What is Yentreve used for?
Yentreve is used to treat moderate and severe stress urinary incontinence (SUI) in women. This disorder causes involuntary loss of urine during physical exertion or as a result of coughing, laughing, sneezing, lifting or exercising). it can only be obtained with a prescription.
How is Yentreve used?
The recommended dosage of Yentreve is 40 mg twice a day. It may be beneficial for some patients to start treatment at 20 mg twice daily for two weeks before moving to 40 mg twice daily to reduce nausea and dizziness. The benefit of the treatment should be re-evaluated at regular intervals.
The association of Yentreve with a pelvic floor muscle exercise program may be of further benefit.
How does Yentreve work?
The active substance in Yentreve is duloxetine, a combined serotonin and norepinephrine reuptake inhibitor (SNRI). Duloxetine works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrernaline from being reabsorbed by nerve cells in the brain and spinal cord. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. By blocking their reabsorption, duloxetine increases the number of neurotransmitters in the space between nerve cells, increasing the level of communication between these cells. Its mode of action in SUI is unclear, but it is believed that by increasing the concentrations of 5-hydroxytryptamine and norepinephrine at the nerves that control the muscles of the urethra (the channel that connects the bladder to the outside), the duloxetine causes a stronger urethral closure when filling urine.Through this mechanism, Yentreve prevents involuntary loss of urine during physical exertion such as a cough or a laugh.
How has Yentreve been studied?
Yentreve has been studied in a total of 2,850 women with SUI. The four main studies involving 1,913 patients spanned 12 weeks and compared Yentreve (mostly given at a dose of 40 mg twice a day) with placebo (a dummy treatment). The main measures of efficacy were the frequency of incontinence episodes (IEF, that is, the number of incontinence episodes per week) reported in a diary by patients and the scores in a quality of life questionnaire specific for incontinence (I -QOL).
What benefit has Yentreve shown during the studies?
In all four studies, patients treated with Yentreve had fewer incontinence episodes after 12 weeks, about four or five fewer episodes per week than the frequency prior to the start of the study.IEF decreased by 52% in the Yentreve group compared to the 33% decrease seen in the placebo group. The scoring questionnaire improved in the Yentreve group compared to the placebo group. Yentreve was more effective than placebo only in patients with "stress incontinence greater than 14 episodes of incontinence per week (moderate to severe SUI) at the start of the study."
What is the risk associated with Yentreve?
The most commonly reported side effects with Yentreve (seen in more than 1 in 10 patients) are nausea, dry mouth, constipation and tiredness. For the full list of side effects reported with Yentreve, see the package leaflet. Yentreve must not be used in people who are hypersensitive (allergic) to duloxetine or any of the other ingredients. In addition, the medicine must not be used by patients with certain types. liver disease or severe kidney disease. Yentreve must not be taken together with monoamine oxidase inhibitor medicines (a type of antidepressant), fluvoxamine (another antidepressant) and ciprofloxacin or enoxacin (antibiotics). Treatment with Yentreve must not be started in patients with uncontrolled hypertension due to the risk of hypertensive crisis (sudden and sometimes dangerous rise in blood pressure).
Why has Yentreve been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Yentreve's benefits are greater than its risks for the treatment of moderate to severe stress urinary incontinence. The CHMP therefore recommended that it be given a "marketing authorization". trade for this medicine.
Other information about Yentreve:
On 11 August 2004, the European Commission granted Eli Lilly Nedreland B.V. a "Marketing Authorization" for Yentreve, valid throughout the European Union.
For the full version of Yentreve's EPAR, click here.
Last update of this summary: 05-2008.
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