Vesomni: Drug Composition, Indications, Administration, Warnings, Interactions and Studies

It is a medicine used to treat men with urinary problems.

Intended to relieve the urinary symptoms of an enlarged prostate gland ( benign prostatic hyperplasia or BPH), for example, you need to urinate frequently or urgently, but have a weak urine stream or cannot fully empty your bladder when you do.

Vesomni ingredients

Vesomni is a fixed-dose combination tablet containing 6.0 mg of solifenacin (antimuscarinic) and 0.4 mg of tamsulosin (alpha-blocker) used to treat lower urinary tract symptoms associated with benign prostatic hyperplasia.

These drugs have independent and complementary mechanisms of action in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia, with storage symptoms.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, fertility, embryo-fetal development, genotoxicity, and carcinogenic potential.

And they do not raise a concern for potentiation or synergy of adverse effects when solifenacin and tamsulosin are combined.

What is Vesomni used for?

Vesomni is prescribed to men with symptoms of storage or urination. Vesomni is often used when treatment with a mono product has not brought relief to the patient.

The patient should be examined to exclude the presence of other conditions, which can cause symptoms similar to benign prostatic hyperplasia.

Other causes of frequent urination (heart failure or kidney disease) should be evaluated before starting Vesomni. If there is a urinary tract infection, appropriate antibacterial therapy should be started.

Pharmacodynamic effects

Vesomni tablets consist of two active substances with independent and complementary effects on lower urinary tract symptoms associated with benign prostatic hyperplasia, with storage symptoms:

Solifenacin improves storage function problems related to non-neuronally released acetylcholine activating M3 receptors in the bladder.

Non-neuronally released acetylcholine sensitizes urothelial sensory function and manifests as urgency and urinary frequency.

Tamsulosin improves voiding symptoms (increases peak urinary flow rate) by relieving obstruction through relaxation of smooth muscle in the prostate, bladder neck, and urethra. It also improves storage symptoms.

How does the Vesomni work?

Vesomni tablets contain two active ingredients, solifenacin and tamsulosin.

The prostate gland, found only in men, is at the top of the tube that connects the bladder to the outside (urethra).

The prostate often enlarges with advanced age (benign prostatic hyperplasia), pressing on the urethra and obstructing the flow of urine from the bladder.

This can cause various urinary symptoms, such as difficulty urinating, not being able to fully empty the bladder, and the need to urinate more frequently or urgently.

Tamsulosin is a type of medicine called an alpha blocker. It works by blocking alpha receptors found in the muscle of the prostate gland.

This action causes the prostate muscle to relax, which relieves pressure on the urethra and allows urine to flow freely through the prostate gland. This makes it easier to pass urine and empty your bladder.

The different and combined actions of these drugs can help relieve symptoms of an enlarged prostate in men whose symptoms have not improved with tamsulosin alone.

Vesomni tablets are modified release tablets. They are designed to release medications gradually as they pass through the stomach and intestines, so that a constant amount of medication is absorbed into the bloodstream throughout the day.

The tablets should be swallowed whole and should not be chewed, broken or crushed as this would prevent the modified release action from stopping working.

How should I take Vesomni?

One Vesomni tablet should be taken once a day, preferably at the same time each day.

The tablet should be swallowed whole with a glass of water and should not be broken, chewed, or crushed. It can be taken with or without food.

If you forget to take a dose, don’t worry, just skip that dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

Keep taking this medicine every day unless your doctor tells you to stop. Discontinuation of treatment is likely to cause urinary symptoms to reappear.

Patients with kidney failure

The effect of renal impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active ingredients is well known.

Vesomni can be used in patients with mild to moderate renal impairment (creatinine clearance> 30 ml / min).

Patients with severe renal impairment (creatinine clearance ≤ 30 ml / min) should be treated with caution and the maximum daily dose in these patients is one Vesomni tablet (6 mg / 0.4 mg).

Patients with liver failure

The effect of hepatic impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active ingredients is well known.

Vesomni can be used in patients with mild hepatic impairment. Patients with moderate hepatic impairment should be treated with caution and the maximum daily dose in these patients is one Vesomni tablet (6 mg / 0.4 mg).

In patients with severe hepatic impairment, the use of Vesomni is contraindicated.

Moderate and strong cytochrome P450 3A4 inhibitors

The maximum daily dose of Vesomni should be limited to one tablet (6 mg / 0.4 mg). Vesomni should be used with caution in patients treated concurrently with moderate or strong CYP3A4 inhibitors, eg. Eg verapamil, ketoconazole, ritonavir, nelfinavir, itraconazole.

Pediatric population

There are no relevant indications for the use of Vesomni in children and adolescents.

Warnings

This medicine may cause dizziness, lightheadedness and, rarely, fainting. Be careful going from a lying or sitting position to sitting or standing, especially if you wake up at night, until you know how this medicine affects you.

If you feel dizzy or light-headed at any time during treatment, sit or lie down until symptoms pass.

This medicine may cause drowsiness, dizziness, or blurred vision and therefore may affect your ability to drive or operate machinery safely.

Do not drive or operate machinery until you know how this medicine affects you and you are sure it will not affect your performance.

This drug does not cause prostate cancer, but prostate cancer can be another cause of an enlarged prostate.

For this reason, tests for prostate cancer should be done before starting treatment with this medicine and at regular intervals thereafter.

One test that may be done is a digital rectal exam (DRE), to check if the prostate is enlarged. The other is to measure the level of prostate specific antigen (PSA) in the blood.

If you are scheduled to have cataract eye surgery, it is important that you tell your eye specialist if you are or have been taking this medication.

This is because tamsulosin can cause the pupil to dilate poorly and the iris (the colored circular part of the eye) to become flexible during the procedure.

The specialist should know if you have been taking this medicine so that they can take appropriate precautions with the medications and techniques they use during surgery.

You may be asked to stop taking this medicine for a period of time before cataract surgery. Check with your doctor.

You should use Vesomni with caution in

  • Men with decreased liver function. Men with decreased kidney function. Men at risk of being completely unable to urinate. Men with a blockage in the stomach or intestines.
  • Men who are constipated or at risk of decreased muscle contraction in the muscles of the stomach or intestines. Gastroesophageal reflux disease.
  • Men taking medications that can cause or worsen reflux esophagitis, for example bisphosphonates such as alendronate. Men with hiatal hernia.
  • Men with an involuntary nervous system disorder usually cause weakness and numbness (autonomic neuropathy).
  • Men with a slow heart rate. Men with a low level of potassium in the blood (hypokalaemia).

Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, Vesomni should be discontinued and appropriate therapy or measures taken.

As with other alpha1 adrenergic receptor antagonists, a reduction in blood pressure may occur in individual cases during treatment with tamsulosin, as a result of which, rarely, syncope may occur.

Patients starting Vesomni should be advised to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until symptoms disappear.

Intraoperative floppy iris syndrome (a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients who received prior tamsulosin hydrochloride treatment.

Intraoperative floppy iris syndrome can increase the risk of eye complications during and after the operation.

Therefore, initiation of Vesomni therapy is not recommended in patients for whom cataract or glaucoma surgery has been scheduled.

Discontinued treatment with Vesomni 1-2 weeks prior to cataract or glaucoma surgery is considered anecdotally helpful, but the benefit of discontinuation of therapy has not been established.

During the preoperative evaluation, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery receive or have been treated with Vesomni to ensure that appropriate measures are implemented to treat intraoperative floppy iris syndrome during surgery.

Vesomni should be used with caution in combination with moderate and strong CYP3A4 inhibitors and should not be used in combination with strong CYP3A4 inhibitors, for example ketoconazole, in patients with a CYP2D6 deficient metabolic phenotype or who are using strong CYP2D6 inhibitors, for example, paroxetine.

Vesomni should not be used in

  • Women.
  • Adolescents under 18 years of age.
  • People on hemodialysis for kidney failure.
  • People with severely decreased liver function.
  • People with severely decreased kidney function or moderately decreased liver function taking ketoconazole, itraconazole, ritonavir, or nelfinavir.
  • People with severe stomach or intestinal disorders, for example sudden expansion of the large intestine in advanced ulcerative colitis or Crohn’s disease (toxic megacolon).
  • People with a condition called myasthenia gravis in which there is abnormal muscle weakness. Angle closure glaucoma.
  • People with a history of drops in blood pressure that cause dizziness when getting up from sitting or lying down (postural hypotension).
  • This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you think you have experienced an allergic reaction, stop using this medicine and tell your doctor or pharmacist immediately.

Vesomni side effects

Medications and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this drug.

Just because a side effect is established here does not mean that all people using this drug will experience that or any side effect.

Common side effects (affects 1 to 10 in 100 men)

  • Dizziness
  • Blurry vision.
  • Fatigue.
  • Dry mouth.
  • Constipation .
  • Feeling sick
  • Indigestion.
  • Abdominal pain.
  • Abnormal ejaculation

Uncommon side effects (affects 1 to 10 in 1,000 men)

  • Drowsiness.
  • Feeling weak and tired
  • Drop in blood pressure when going from lying or sitting to sitting or standing, causing dizziness and lightheadedness (postural hypotension).
  • Awareness of your heartbeat (palpitations).
  • Urinary tract infection or cystitis.
  • Difficulty or inability to urinate.
  • Dry eyes, nose or throat.
  • Inflammation of the lining of the nose (rhinitis) that causes a blocked or runny nose.
  • Dry Skin.
  • Itching, rash, or hives .
  • Taste alteration
  • Gastroesophageal reflux (heartburn).
  • Diarrhea .
  • Ankle swelling due to fluid retention.
  • Headache.

Rare side effects (affects 1 to 10 in 10,000 men)

  • Hardened, compressed stools causing a blockage of the intestine (fecal impaction).
  • Fainting ( syncope ).
  • Swelling of the face, throat, and tongue ( angioedema ). Get medical help immediately if you experience this.

Very rare side effects (affects less than 1 in 10,000 men)

  • Confusion.
  • Hallucinations
  • Persistent and painful erection of the penis ( priapism ).
  • Severe skin rash (erythema multiforme).
  • Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat, and genitals (Stevens-Johnson syndrome).
  • Unknown frequency
  • Decreased appetite.
  • Glaucoma.
  • Vision problems.
  • Muscular weakness.
  • Abnormal heartbeat
  • Changes in voice
  • Nosebleeds
  • Abnormal liver or kidney function
  • Increased level of potassium in the blood.
  • Severe allergic reaction (anaphylactic shock).

The side effects listed above may not include all the side effects reported by the drug manufacturer.

For more information on other possible risks associated with this medicine, read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine (Vesomni) affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before starting treatment with this medicine.

Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure the combination is safe.

If this drug is taken with drugs that can lower blood pressure, this effect may be increased, with an increased likelihood of dizziness or fainting.

Other medications that can lower blood pressure include the following. If you take any of these with this medicine, tell your doctor if you feel very dizzy:

Anesthesia, baclofen, diuretics such as furosemide, medicines for high blood pressure, nitrates such as glyceryl trinitrate, other alpha blockers, for example prazosin.

Phosphodiesterase type 5 inhibitors for impotence, eg avanafil, sildenafil, vardenafil, tadalafil.

The following medications can increase the level of tamsulosin in the blood by interfering with its breakdown by the body.

If you take any of these drugs with this drug, tell your doctor if you experience new or major side effects from tamsulosin, for example dizziness:

  • Cimetidine.
  • Erythromycin.
  • Paroxetine.
  • Terbinafine.
  • Verapamil .

The following medications can reduce the breakdown of solifenacin and tamsulosin by the liver and therefore may increase the amount of medications in the blood.

You should not take them in combination with this medicine if you have severely decreased kidney function or moderately decreased liver function (your doctor will know):

  • Itraconazole.
  • Ketoconazole.
  • Nelfinavir.
  • Ritonavir.

The following drugs can potentially lower the blood level of this drug and make it less effective:

  • Carbamazepine.
  • Phenobarbital.
  • Phenytoin
  • Primidona.
  • Rifampicin

There may be an increased risk of side effects such as dry mouth, blurred vision, constipation, and difficulty urinating, if solifenacin is taken with other medications that have antimuscarinic effects, such as the following:

  • Amantadine, antihistamines, eg brompheniramine, chlorphenamine. Antimuscarinic drugs for Parkinson’s symptoms, eg procyclidine, orphenadrine, trihexyphenidyl.
  • Antimuscarinic drugs for urinary incontinence, eg tolterodine, oxybutynin, propiverine, antipsychotic drugs, eg haloperidol, chlorpromazine, clozapine, antispasmodic drugs, eg hyoscine, atropine and disopyramide.
  • Monoamine oxidase inhibitor antidepressants (MAOIs), eg phenelzine, tranylcypromine, tricyclic antidepressants, eg amitriptyline, clomipramine.
  • Medications like pilocarpine that work by stimulating muscarinic receptors can make solifenacin less effective.

Solifenacin can reduce the effects of the following medications in the intestine:

  • Cisaprida.
  • Domperidona.
  • Metoclopramide.

If you experience dry mouth as a side effect of this medication, it is possible that medications designed to dissolve and be absorbed from the lower part of the tongue, for example sublingual glyceryl trinitrate (GTN) tablets , are less effective.

This is because the tablets do not dissolve properly in dry mouth. To resolve this, have a drink of water before taking the sublingual tablets.

Studies carried out with Vesomni

A 1-year observational study evaluated the impact of Vesomni on quality of life and satisfaction with treatment in routine clinical practice.

Men with lower urinary tract symptoms / benign prostatic hyperplasia who did not respond adequately to monotherapy received Vesomni in clinical practice.

Clinical findings, medications for lower urinary tract symptoms / benign prostatic hyperplasia, and treatment emergent adverse events (TEAE) were collected for 1 year before and after the prescription of Vesomni.

Each tablet contains a 6 mg layer of solifenacin succinate, corresponding to 4.5 mg of solifenacin free base and a 0.4 mg layer of tamsulosin hydrochloride, corresponding to 0.37 mg of tamsulosin free base.

Patient-reported outcomes included:

  • The Overactive Bladder Questionnaire (OAB-q),
  • The International Prostate Symptom Score (IPSS),
  • The Visual Analogue Treatment Satisfaction Scale (TS-VAS) and
  • The European Five-Dimensional Quality of Life Questionnaire (EQ-5D-5L).

Vesomni treatment produced clinically significant improvements in the symptom discomfort score of the overactive bladder questionnaire at weeks 4–8 and 9–18.

The total subscale and coping, worry, and sleep scores at weeks 4–8, and the total subscale and coping and sleep scores at weeks 9-18.

This is the first report of the benefit of treatment and the safety / tolerability of Vesomni in routine clinical practice; demonstrated clinically significant improvements in health-related quality of life and satisfaction with treatment.

These results support Vesomni as a treatment option for men with urinary tract symptoms / benign prostatic hyperplasia that does not respond adequately to monotherapy.

Clinical efficacy and safety

Efficacy was demonstrated in a pivotal phase 3 study in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia with voiding (obstructive) symptoms and at least the next level of storage symptoms.

The Vesomni showed statistically significant improvements from the start to the end of the study. The Vesomni showed superior improvement compared to the tamsulosin-controlled oral absorption system, as well as in the frequency of urination.