Revefenacin Uses, Dosage, Side Effects & Price | DrugsAtlas
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DRUG NAME: Revefenacin
Therapeutic Class: Anti Cholinergic (Long-Acting Muscarinic Antagonist (LAMA))
Subclass: Bronchodilator
Specialty: Pulmonology
Schedule (India): H
Route(s): Inhalation (Nebulised solution)
Formulations Available in India:
| Formulation | Strength |
| Nebuliser solution (unit-dose vial) | 175 mcg/3 mL |
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
❖ Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Bronchodilation
| Parameter | Recommendation |
| Starting dose | 175 mcg (one 3 mL vial) via standard jet nebuliser once daily |
| Titration | Not applicable; fixed-dose regimen |
| Usual maintenance dose | 175 mcg once daily |
| Maximum dose | 175 mcg once daily (do not exceed) |
Clinical Notes:
- Administer via standard jet nebuliser connected to an air compressor with mouthpiece
- Do not mix with other nebulised medications in the same nebuliser chamber
- Not indicated for acute bronchospasm relief or rescue therapy
- Discard vial immediately after opening; do not store opened vials
- Clinical benefit assessment recommended at 4–6 weeks of consistent use
Secondary Indications — Adults (Off-label, if any)
Not established — No documented off-label uses in Indian clinical practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Not applicable — Revefenacin is not approved for paediatric use.
Secondary Indications — Paediatric (Off-label, if any)
Not applicable — No off-label paediatric indications documented.
| Age Group | Recommendation |
| <18 years | Not recommended; safety and efficacy not established |
Safety Statement:
- Use in patients below 18 years is not recommended
- No paediatric pharmacokinetic or safety data available
- Any investigational use would require specialist supervision
RENAL ADJUSTMENT
| Renal Function | Recommendation |
| Mild impairment (eGFR 60–89 mL/min) | No dose adjustment required |
| Moderate impairment (eGFR 30–59 mL/min) | No dose adjustment required |
| Severe impairment (eGFR <30 mL/min) | Use with caution; monitor for anticholinergic adverse effects |
| Haemodialysis | No specific data; use with caution |
Note: Revefenacin is primarily metabolized by esterases rather than renal excretion; however, active metabolite may accumulate in severe renal impairment.
HEPATIC ADJUSTMENT
| Hepatic Function | Recommendation |
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | Use with caution; limited data available |
| Severe impairment (Child-Pugh C) | Avoid use; insufficient data; consider alternative LAMA if required |
CONTRAINDICATIONS
- Hypersensitivity to revefenacin or any component of the formulation
- Known severe hypersensitivity to atropine or other anticholinergic agents (structural class effect)
CAUTIONS
- Narrow-angle glaucoma: Risk of precipitating or worsening acute angle-closure; avoid direct ocular exposure to nebulised mist
- Prostatic hyperplasia / Bladder outlet obstruction: May exacerbate urinary retention; monitor urinary symptoms
- Severe renal or hepatic impairment: Limited data; use with enhanced monitoring
- Cardiovascular disease: Use with caution in patients with unstable cardiac conditions or significant arrhythmias
- Not for acute bronchospasm: Ensure patient has access to SABA rescue medication
- Paradoxical bronchospasm: Discontinue immediately if worsening respiratory symptoms occur after nebulisation
PREGNANCY
| Parameter | Information |
| Risk category | Not formally classified in India; no adequate human data available |
| Overall safety | Use only if potential benefit to mother justifies potential fetal risk |
| Preferred alternatives | Tiotropium (more clinical experience in pregnancy); ipratropium for short-term use |
| When may be used | Only when essential for COPD management and alternatives unsuitable; specialist input advised |
| Monitoring | Standard antenatal surveillance; monitor maternal respiratory status |
LACTATION
| Parameter | Information |
| Compatibility | Unknown; use with caution |
| Drug levels in milk | Unknown; likely low due to quaternary ammonium structure and inhaled route |
| Preferred alternatives | Tiotropium (more clinical experience during breastfeeding) |
| Infant monitoring | Observe for anticholinergic effects: dry mouth, poor feeding, irritability, constipation |
ELDERLY
| Parameter | Recommendation |
| Starting dose | 175 mcg once daily (same as adults) |
| Titration | Not applicable |
| Slower titration needed | No |
| Extra risks | Urinary retention (prostatic hypertrophy common); constipation; blurred vision; cognitive effects in frail elderly; falls risk |
| Monitoring | Urinary symptoms; intraocular pressure in at-risk patients; inhaler technique; hydration status |
Note: Nebulised delivery may be particularly suitable for elderly patients who cannot effectively use MDI or DPI devices due to poor coordination or inspiratory effort.
MAJOR DRUG INTERACTIONS
| Interacting Drug/Class | Interaction | Recommendation |
| Other LAMAs (tiotropium, glycopyrronium, umeclidinium, aclidinium) | Additive anticholinergic effects; therapeutic duplication | Avoid co-administration |
| Ipratropium (short-acting anticholinergic) | Increased anticholinergic burden with regular concurrent use | Avoid regular concurrent use |
| OATP1B1/OATP1B3 inhibitors (rifampicin, cyclosporine) | May increase systemic exposure of revefenacin active metabolite | Use with caution; monitor for anticholinergic adverse effects |
MODERATE DRUG INTERACTIONS
| Interacting Drug/Class | Interaction | Recommendation |
| Tricyclic antidepressants (amitriptyline, imipramine) | Additive anticholinergic effects — urinary retention, dry mouth, constipation | Monitor for anticholinergic symptoms |
| First-generation antihistamines (chlorpheniramine, promethazine) | Additive anticholinergic and sedative effects | Monitor; prefer second-generation antihistamines |
| Opioid analgesics | Both may cause constipation and urinary retention | Monitor bowel and bladder function |
| Antipsychotics with anticholinergic properties (chlorpromazine, olanzapine) | Additive anticholinergic burden | Monitor for urinary retention, cognitive impairment |
| LABAs (formoterol, salmeterol) | Complementary mechanism; no significant interaction | Safe to combine for COPD management |
| Inhaled corticosteroids (ICS) | No pharmacokinetic interaction | Safe for concurrent use |
COMMON ADVERSE EFFECTS
- Cough
- Headache
- Nasopharyngitis
- Upper respiratory tract infection
- Back pain
- Dizziness
- Dry mouth
SERIOUS ADVERSE EFFECTS
| Adverse Effect | Clinical Action |
| Paradoxical bronchospasm | Discontinue immediately; administer SABA rescue; do not rechallenge |
| Acute angle-closure glaucoma (eye pain, blurred vision, visual halos, conjunctival congestion) | Discontinue; urgent ophthalmology referral |
| Urinary retention | Discontinue if severe; urology referral in patients with prostatic hyperplasia |
| Hypersensitivity reactions (rash, angioedema, anaphylaxis) | Discontinue; emergency management; do not rechallenge |
MONITORING REQUIREMENTS
Baseline:
- Confirm COPD diagnosis with spirometry (post-bronchodilator FEV₁/FVC <0.70)
- Baseline symptom assessment (CAT score or mMRC dyspnoea scale)
- Screen for narrow-angle glaucoma, prostatic hyperplasia, bladder dysfunction
- Assess nebuliser technique and equipment availability
After Initiation (4–6 weeks):
- Reassess symptom control and bronchodilator response
- Monitor for anticholinergic adverse effects (dry mouth, urinary symptoms, visual disturbance)
- Verify correct nebulisation technique and compliance
Long-term:
- Spirometry at 6–12 monthly intervals
- Annual review of glaucoma risk and urinary symptoms in at-risk patients
- Nebuliser maintenance and technique check periodically
- Reassess continued need and COPD phenotype annually
BRANDS AVAILABLE IN INDIA
| Brand Name | Composition | Manufacturer |
| Brospira Respules | Revefenacin 175 mcg/3 mL | Glenmark |
| Revela Respules | Revefenacin 175 mcg/3 mL | Zydus |
| Respimax | Revefenacin 175 mcg/3 mL | Cipla |
PRICE RANGE (INR)
| Product | Approximate Price (INR) |
| Revefenacin 175 mcg/3 mL (per unit-dose vial) | ₹75 – ₹120 |
| Box of 30 vials | ₹2,250 – ₹3,600 |
NLEM Status: Not included in current NLEM
Note: Prices may vary by region and pharmacy. Limited government supply availability.
CLINICAL PEARLS
- Nebulised LAMA advantage: Revefenacin is the only nebulised once-daily LAMA available in India; particularly suited for COPD patients who cannot coordinate MDI/DPI usage (elderly, debilitated, arthritis, severe airflow limitation)
- Do not mix: Never combine with other nebulised medications in the same chamber; administer separately
- Not for rescue: Always ensure patient has SABA (salbutamol nebules or MDI) for acute symptom relief
- Single-use vials: Discard opened vials immediately; do not store for later use
- Slower onset: Benefits typically become evident after several days of consistent use; counsel patients on expected timeline
- Equipment requirement: Requires standard jet nebuliser with air compressor; ultrasonic nebulisers not recommended
TAGS
Revefenacin; COPD; LAMA; anticholinergic; nebulised bronchodilator; maintenance therapy; elderly-safe; inhalation; respiratory; pulmonology
VERSION
RxIndia v0.2 — 03 Feb 2026
REFERENCES
- CDSCO (Product approval and labelling information)
- Indian Pharmacopoeia
- AIIMS Formulary
- API Textbook of Medicine
- GOLD 2023 Report (referenced for COPD classification only)
- Goodman & Gilman’s The Pharmacological Basis of Therapeutics
- Harrison’s Principles of Internal Medicine
- Manufacturer’s Product Inserts (India-registered products)
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Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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