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Molecule

Revefenacin

Anticholinergic
Available on request
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Revefenacin is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is available as inhalation solution. MedsAcross supplies Revefenacin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Anticholinergic, Cholinergic Antagonists
US FDA first approval
9 November 2018
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Inhalation
Dosage forms
Inhalation solution
Identifiers
UNII G2AE2VE07OCAS 864750-70-9DrugBank DB11855Q27278649

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Source: US FDA prescribing information

How it works

Revefenacin is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo models, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of revefenacin is predominantly a site-specific effect.

Source: US FDA prescribing information

Dosing overview

The recommended dosage is 175 mcg YUPELRI (one 175 mcg unit‑dose vial) administered by oral inhalation once daily by nebulizer using a mouthpiece. Administration Overview YUPELRI should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of YUPELRI have been established in clinical trials when administered using the PARI LC ® Sprint nebulizer with a mouthpiece and the PARI Trek ® S compressor. The safety and efficacy of YUPELRI delivered from non‑compressor based nebulizer systems have not been established. The YUPELRI unit-dose vial should only be removed from the foil pouch and opened IMMEDIATELY BEFORE USE. The vial and any residual content should be discarded after use. No dosage adjustment is required for geriatric patients, or patients with renal impairment.

Source: US FDA prescribing information

Contraindications

YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.

Source: US FDA prescribing information

Warnings and precautions

• Do not initiate YUPELRI in acutely deteriorating COPD or to treat acute symptoms. • If paradoxical bronchospasm occurs, discontinue YUPELRI and institute alternative therapy. • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. • Immediate hypersensitivity reactions may occur. If such a reaction occurs, therapy with YUPELRI should be stopped at once and alternative treatments should be considered.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in labeling: • Paradoxical bronchospasm • Worsening of narrow-angle glaucoma • Worsening of urinary retention • Immediate hypersensitivity reactions Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.

Source: US FDA prescribing information

Interactions

• Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of YUPELRI with other anticholinergic-containing drugs. • Transporter-related drug interactions: Coadministration of YUPELRI with OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.) may lead to an increase in exposure of the active metabolite. Therefore, coadministration with YUPELRI is not recommended.

Source: US FDA prescribing information

Storage

• Store YUPELRI in the protective foil pouch. • Store at room temperature from 68°F to 77°F (20°C to 25°C), excursions permitted from 59°F to 86°F (15°C to 30°C). Protect from direct sunlight and excessive heat.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Revefenacin, sorted by availability.

MedicineManufacturerRegisterAvailability
Yupelri 175 mcg/3 mL inhalation solutionInhalationViatris SpecialtyUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 9 November 2018Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Revefenacin available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Revefenacin and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Revefenacin have?

The catalogue lists 1 brand names for Revefenacin, including Yupelri.

Is Revefenacin approved by the US FDA?

Yes. The US FDA first approved Revefenacin on 9 November 2018, according to Drugs@FDA.

Does Revefenacin need cold chain shipping?

No listed presentation of Revefenacin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. YUPELRI prescribing information (Viatris Specialty). U.S. National Library of Medicine, DailyMed. Retrieved 3 May 2022

Request Revefenacin for export supply

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