Schedule H

Oral

• Vibegron 75 mg tablets

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Overactive Bladder Syndrome (OAB)

Indicated for treatment of overactive bladder with symptoms of urinary urgency, increased urinary frequency, and/or urge urinary incontinence in adults.

Parameter Recommendation

Starting dose 75 mg once daily orally

Titration Not required; fixed-dose regimen

Usual maintenance dose 75 mg once daily

Maximum dose 75 mg once daily

Clinical Notes:

• May be taken with or without food

• Tablets may be crushed and mixed with applesauce if swallowing difficulty exists

• Clinical benefit typically observed within 2–4 weeks; reassess response at 8–12 weeks

• Unlike mirabegron, vibegron does not cause clinically significant blood pressure elevation

• Can be considered as first-line option or when antimuscarinics are not tolerated

Secondary Indications — Adults (Off-label, if any):

Not applicable.

No established off-label indications documented in Indian clinical practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India):

Not approved for paediatric use in India.

Safety and efficacy have not been established in patients below 18 years of age.

Secondary Indications — Paediatrics (Off-label, if any):

Not applicable.

Statement: Use in patients below 18 years is NOT RECOMMENDED due to lack of safety and efficacy data.

• Known hypersensitivity to vibegron or any excipient

• Urinary retention

• Gastric retention

• Uncontrolled narrow-angle glaucoma

• Bladder outlet obstruction — increased risk of urinary retention; monitor post-void residual volume

• Patients with elevated post-void residual urine volume — assess before and during treatment

• Concurrent use with antimuscarinic agents — may increase risk of urinary retention; avoid combination if possible

• Severe renal impairment (eGFR <30 mL/min) — limited data; use with caution

• Severe hepatic impairment — avoid due to lack of data

• Concurrent strong CYP3A4 inducers — may reduce vibegron efficacy

• Elderly patients with multiple comorbidities — monitor renal function and urinary symptoms

Parameter Details

Risk assessment Limited human data; animal reproductive studies show no evidence of teratogenicity

Overall recommendation Not recommended during pregnancy; use only if potential benefit clearly outweighs risk

Preferred alternatives Behavioural therapies first-line; if pharmacotherapy essential, oxybutynin or tolterodine may be considered with caution

Specialist input Required — urogynaecologist/obstetrician coordination

Monitoring Maternal urinary symptoms; fetal growth monitoring if use unavoidable

Parameter Details

Breastfeeding compatibility Not recommended; unknown if excreted in human breast milk

Drug levels in milk Unknown; animal studies suggest excretion in milk

Preferred alternatives Behavioural modifications; oxybutynin may be considered (more data available)

Monitoring in infant If unavoidable use — monitor for feeding difficulties, irritability, dry mouth, or constipation signs

Recommendation Avoid during breastfeeding or discontinue breastfeeding if treatment essential

Parameter Recommendation

Starting dose 75 mg once daily (same as adult dose)

Titration Not required

Specific considerations No dose adjustment needed based on age alone

Advantages Does not cause clinically significant BP elevation (unlike mirabegron); minimal anticholinergic effects; does not affect cognition

Monitoring Renal function; post-void residual volume if symptoms of incomplete emptying; urinary retention signs

Clinical note Preferred beta-3 agonist option in elderly patients with hypertension due to neutral BP effect

Interacting Drug/Class Effect & Management

Digoxin Vibegron inhibits P-glycoprotein; may increase digoxin plasma concentrations — monitor serum digoxin levels; initiate digoxin at lowest dose when starting vibegron

Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital) May significantly reduce vibegron plasma concentrations and efficacy — avoid combination or monitor closely for reduced therapeutic effect

Interacting Drug/Class Effect & Management

Antimuscarinic agents (solifenacin, tolterodine, oxybutynin) Additive risk of urinary retention when combined — avoid combination if possible; if used together, monitor for urinary retention

CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) May modestly increase vibegron exposure — no dose adjustment needed but monitor for adverse effects

CYP2D6 substrates with narrow therapeutic index (metoprolol) Vibegron is a weak CYP2D6 inhibitor — monitor for increased effects of CYP2D6 substrates

Diuretics May theoretically alter urinary symptoms — monitor clinical response

• Headache

• Nasopharyngitis

• Diarrhoea

• Nausea

• Upper respiratory tract infection

• Urinary tract infection

• Constipation

• Urinary retention — particularly in patients with bladder outlet obstruction; requires immediate discontinuation; catheterisation may be necessary

• Hypersensitivity reactions (angioedema, urticaria) — rare; discontinue immediately and provide appropriate treatment

• Severe allergic reactions — rare; requires emergency management

Phase Parameters

Baseline (before initiation) Renal function (serum creatinine/eGFR); hepatic function if liver disease suspected; post-void residual volume in patients at risk of retention; confirm absence of urinary retention

At 8–12 weeks Clinical response assessment (urgency, frequency, incontinence episodes); tolerability evaluation

Long-term (every 6–12 months) Renal function in elderly; post-void residual if symptoms of incomplete emptying develop; blood pressure (though BP elevation is minimal with vibegron)

• Urovibe (Alembic Pharmaceuticals)

• Deavor (Sun Pharma)

Note: Limited brand availability as vibegron is relatively recently introduced in India; verify current market availability

Notes:

• Not included in National List of Essential Medicines (NLEM) 2022

• Not under NPPA price control

• Not available through government supply; private sector only

• Price may vary between brands

• BP-neutral advantage: Unlike mirabegron, vibegron does not cause clinically significant blood pressure elevation; preferred option in hypertensive patients requiring beta-3 agonist therapy

• Fixed-dose simplicity: No titration required; 75 mg once daily is both the starting and maintenance dose — simplifies prescribing

• Elderly-friendly: Lacks anticholinergic effects; does not affect cognition; no significant BP effects — makes it particularly suitable for elderly OAB patients

• Can be crushed: Unlike mirabegron extended-release tablets, vibegron tablets can be crushed and mixed with soft food for patients with swallowing difficulties

• Assess for retention risk: Always evaluate post-void residual volume before initiating therapy in patients with suspected bladder outlet obstruction or BPH

• Allow adequate trial: Clinical improvement may take 2–4 weeks; assess efficacy at 8–12 weeks before considering treatment failure or switch

vibegron; beta-3 agonist; overactive bladder; OAB; urinary urgency; urge incontinence; frequency; non-anticholinergic; elderly-safe; BP-neutral; Schedule H

RxIndia v1.0 — 02 Jun 2025

• CDSCO approved prescribing information (Vibegron)

• Indian manufacturer product inserts (Alembic, Sun Pharma)

• API Textbook of Medicine (Urology section)

• National Formulary of India (NFI)

• NLEM 2022 (Vibegron not listed)

• AIIMS Urology Department Formulary (comparative review of beta-3 agonists)