Vesomni

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Vesomni on Prescriptsy

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Vesomni is a prescription-only combination medicine containing solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg in a single modified-release tablet.

It is designed for adult men with benign prostatic hyperplasia (BPH) who experience both voiding symptoms (weak urinary stream, hesitancy, intermittency, incomplete emptying) and storage symptoms (urgency, frequency, nocturia, urge incontinence) that are not adequately controlled by tamsulosin monotherapy.

The combination addresses both the obstructive and irritative components of lower urinary tract symptoms (LUTS) associated with BPH.

Vesomni is manufactured by Astellas Pharma and is classified as a prescription-only medicine (POM) in the United Kingdom.

Benign prostatic hyperplasia is one of the most common conditions affecting men over the age of 50, with autopsy studies suggesting histological BPH is present in approximately 50% of men aged 51 to 60 and over 80% of men aged over 80.

LUTS associated with BPH significantly affect quality of life, disrupting sleep (nocturia), causing embarrassment (urgency and incontinence), and interfering with daily activities.

NICE guideline NG97 provides comprehensive recommendations for the assessment and management of LUTS in men.

This page provides a detailed clinical guide to Vesomni, covering its mechanism of action, dosage and administration, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Vesomni

Before reading further, note these essential safety points.

• Vesomni must not be crushed, chewed, or split. The tablet must be swallowed whole to maintain the modified-release properties of the tamsulosin component.
• Vesomni is contraindicated in patients with severe hepatic impairment, urinary retention, uncontrolled narrow-angle glaucoma, and myasthenia gravis.
• If you are having or planning cataract or glaucoma surgery, inform your ophthalmologist that you are taking or have taken Vesomni.
• Rise slowly from sitting or lying down, particularly in the first few days of treatment, as Vesomni can cause dizziness and postural hypotension.

Understanding BPH and lower urinary tract symptoms

Benign prostatic hyperplasia is a non-cancerous enlargement of the prostate gland resulting from proliferation of both stromal and epithelial cells in the transitional zone of the prostate.

As the prostate enlarges, it can compress the prostatic urethra, increasing urethral resistance and causing voiding (obstructive) symptoms including a weak or intermittent urinary stream, hesitancy, straining to void, prolonged micturition, terminal dribbling, and a sensation of incomplete bladder emptying.

The relationship between prostate size and symptom severity is not linear. Many men with significantly enlarged prostates have few symptoms, while others with modest enlargement have substantial LUTS.

This is because symptoms depend not only on the physical obstruction (static component) but also on the tone of smooth muscle in the prostate and bladder neck (dynamic component, mediated by alpha-1 adrenoceptors) and on secondary changes in the detrusor muscle caused by chronic obstruction.

Chronic bladder outlet obstruction from BPH leads to detrusor changes including hypertrophy, increased collagen deposition, and altered receptor expression.

These changes can cause secondary detrusor overactivity, which manifests as storage symptoms: urgency, frequency, nocturia, and urge incontinence.

Approximately 50% to 75% of men with BPH-LUTS have a significant storage symptom component.

This is why many men are not adequately treated by an alpha-blocker alone, which addresses the dynamic obstructive component but does not directly target detrusor overactivity.

How Vesomni works

Vesomni combines two complementary pharmacological mechanisms in a single tablet. Tamsulosin hydrochloride 0.4 mg is a selective alpha-1A adrenoceptor antagonist.

Alpha-1A adrenoceptors are the predominant subtype in the smooth muscle of the prostate, bladder neck, and prostatic urethra.

By blocking these receptors, tamsulosin relaxes prostatic and bladder neck smooth muscle, reducing the dynamic component of urethral obstruction and improving urine flow.

Tamsulosin is selective for alpha-1A over alpha-1B receptors (found predominantly in vascular smooth muscle), which reduces but does not eliminate the risk of blood pressure effects compared with non-selective alpha-blockers.

Solifenacin succinate 6 mg is a selective muscarinic M3 receptor antagonist.

By blocking M3 receptors on detrusor smooth muscle, solifenacin reduces the frequency and amplitude of involuntary detrusor contractions during the filling phase, increasing functional bladder capacity and reducing urgency, frequency, and urge incontinence.

The 6 mg dose is unique to Vesomni (solifenacin is available as 5 mg and 10 mg when prescribed separately as Vesicare) and was selected from dose-finding studies as providing a favourable balance of efficacy and tolerability in the combination setting.

Clinical evidence for Vesomni

The efficacy of the solifenacin-tamsulosin combination was established in the NEPTUNE study, a randomised, double-blind, placebo-controlled trial enrolling men with BPH-LUTS who had persistent storage symptoms despite tamsulosin monotherapy.

The study demonstrated statistically significant improvements in total International Prostate Symptom Score (IPSS), storage subscore, voiding subscore, quality of life score, and patient perception of bladder condition compared with tamsulosin alone.

The NEPTUNE II extension study confirmed sustained efficacy over 52 weeks.

Safety data from the NEPTUNE programme showed that the combination was generally well tolerated.

The most common adverse effects were dry mouth (6.9%) and constipation (2.9%), consistent with the antimuscarinic component.

Importantly, the rate of acute urinary retention was low (0.3%), similar to tamsulosin alone, suggesting that the addition of solifenacin to tamsulosin in appropriately selected patients does not significantly increase the risk of urinary retention.

NICE guideline NG97 recommends that men with bothersome LUTS should initially receive an alpha-blocker (or 5-alpha reductase inhibitor if the prostate is significantly enlarged).

If storage symptoms persist despite alpha-blocker therapy, an antimuscarinic (or mirabegron) can be added. Vesomni provides this combination in a single tablet, improving convenience and potentially adherence.

Dosage and administration

Take one Vesomni tablet once daily, swallowed whole with water. Do not crush, chew, or break the tablet.

Taking it at the same time each day, after breakfast, is recommended. If you miss a dose, take it as soon as you remember on the same day.

If you do not remember until the next day, skip the missed dose. Do not take two tablets in one day.

Vesomni is not a first-line treatment. It is intended for men already established on tamsulosin 0.4 mg daily who continue to have bothersome storage symptoms.

Before starting Vesomni, your prescriber should confirm that your voiding symptoms have improved on tamsulosin and that storage symptoms are the predominant remaining problem.

The clinical benefit of the solifenacin component may take 2 to 4 weeks to develop fully. Continue taking Vesomni as prescribed during this initial period.

If there is no meaningful improvement after 4 to 8 weeks, discuss alternative options with your prescriber.

Side effects of Vesomni

Common side effects

Dry mouth is the most common adverse effect, reported in approximately 7% of patients. It results from antimuscarinic blockade of salivary gland receptors.

Sipping water, sugar-free chewing gum, and good oral hygiene can help manage this. Constipation (approximately 3%) results from reduced gastrointestinal motility.

Dizziness (1% to 2%) may relate to either component and is more likely in the first few days of treatment.

Less common side effects

Dyspepsia, nausea, blurred vision, nasal congestion, ejaculatory disorders (retrograde ejaculation or reduced volume), postural hypotension, fatigue, drowsiness, and headache have been reported. Ejaculatory disorders are a class effect of alpha-1 blockers and are reversible on stopping treatment.

Rare but important side effects

Urinary retention, intraoperative floppy iris syndrome (IFIS) during cataract surgery, angioedema, and priapism (a prolonged painful erection, very rare with tamsulosin) have been reported.

Cognitive effects including confusion and memory impairment have been associated with antimuscarinic drugs as a class.

Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Cataract and glaucoma surgery

Inform your ophthalmologist if you are taking or have ever taken Vesomni (or tamsulosin), as intraoperative floppy iris syndrome (IFIS) can occur during cataract surgery.

IFIS can make surgery more complex but can be managed if the surgeon is aware in advance.

Do not stop Vesomni before surgery without discussing with both your prescriber and your ophthalmologist.

Postural hypotension

Tamsulosin can cause a drop in blood pressure, particularly on standing. This is most likely during the first few days of treatment and in combination with antihypertensive medicines.

Rise slowly from sitting or lying down. If you feel dizzy or lightheaded, sit or lie down until the feeling passes.

Anticholinergic burden

The solifenacin component contributes to the cumulative anticholinergic burden. In older men taking multiple medications with anticholinergic properties, the total burden should be assessed.

A high anticholinergic burden is associated with cognitive decline, falls, and hospitalisation. Consider mirabegron as an alternative to solifenacin if the anticholinergic burden is a concern.

Prostate cancer exclusion

BPH and prostate cancer can present with similar urinary symptoms. Before starting Vesomni, a digital rectal examination and PSA test should be considered to exclude prostate cancer. Vesomni does not treat or prevent prostate cancer.

Lifestyle measures alongside Vesomni

Pharmacological treatment with Vesomni should be combined with lifestyle measures to optimise symptom control.

NICE guideline NG97 recommends that all men with LUTS receive advice on fluid management, including avoiding excessive fluid intake (more than 2 litres per day unless medically indicated), reducing evening fluid intake to minimise nocturia, and limiting caffeine and alcohol consumption, both of which can irritate the bladder and worsen storage symptoms.

Bladder training techniques, including scheduled voiding and urge suppression strategies, can complement the antimuscarinic effect of solifenacin.

Regular physical activity and maintaining a healthy body weight are also recommended, as obesity is associated with worse LUTS outcomes.

Long-term management and monitoring

BPH is a progressive condition, and LUTS may change over time.

Regular review with your prescriber is important to assess treatment efficacy, monitor for side effects (particularly anticholinergic effects in older men), and detect any change in symptoms that might suggest disease progression or an alternative diagnosis.

Your prescriber may periodically reassess whether Vesomni remains the most appropriate treatment, particularly if your symptoms change or if new medications are added that interact with Vesomni components.

An annual review including a discussion of urinary symptoms, medication side effects, and prostate health is reasonable for most men on long-term treatment.

How to get Vesomni in the UK

Vesomni is available on NHS prescription from your GP, a urologist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Your prescriber will typically want to confirm that you have been taking tamsulosin with improvement in voiding symptoms before adding the solifenacin component via Vesomni.

Sources

• Vesomni, Summary of Product Characteristics (EMC)
• Tamsulosin with solifenacin, British National Formulary (BNF)
• Lower urinary tract symptoms in men: management, NICE NG97
• Benign prostate enlargement, NHS
• MHRA Yellow Card Scheme