Brand Name

Yupelri

Generic Name
Revefenacin
View Brand Information
FDA approval date: December 03, 2018
Classification: Anticholinergic
Form: Solution

What is Yupelri (Revefenacin)?

Chronic Obstructive Pulmonary Disease (COPD) can make something as simple as breathing feel like a constant effort. Patients often describe it as living with a tight chest or struggling to catch their breath even at rest. To help ease these symptoms and improve daily comfort, long-acting bronchodilators play a central role in COPD management. Yupelri (revefenacin) is one such medication designed to provide sustained relief by helping the airways stay open for easier breathing.

Yupelri is a long-acting muscarinic antagonist (LAMA), a type of bronchodilator. It is administered through a nebulizer once daily, making it especially suitable for patients who prefer or require nebulized treatments instead of handheld inhalers. Approved by the U.S. Food and Drug Administration (FDA) in 2018, Yupelri offers a convenient, once-daily option to support long-term COPD symptom control.

What does Yupelri do?

Yupelri is prescribed to help adults with chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema, breathe more easily. COPD causes inflammation and narrowing of the airways, leading to persistent coughing, wheezing, and shortness of breath.

By relaxing the airway muscles, Yupelri helps keep the airways open, reducing symptoms like breathlessness and improving lung function over time. Patients using Yupelri as part of a daily maintenance plan often notice better stamina and reduced need for rescue inhalers.

In clinical trials, Yupelri demonstrated significant improvements in lung function, as measured by forced expiratory volume (FEV₁), compared to placebo (FDA, 2024). Many patients report being able to walk farther or perform everyday tasks with less effort when taking this medication consistently.

How does Yupelri work?

Yupelri works by blocking muscarinic (M3) receptors in the smooth muscle of the airways. These receptors are part of the parasympathetic nervous system, which can cause the muscles around the airways to tighten, a process known as bronchoconstriction.

By preventing this tightening, Yupelri allows the muscles to relax, which helps air move more freely in and out of the lungs. This mechanism provides long-lasting bronchodilation that typically lasts for 24 hours after a single dose.

Clinically, this means patients can maintain more stable lung function throughout the day and night, reducing the frequency of flare-ups or hospitalizations related to COPD exacerbations (NIH, 2024).

Yupelri side effects

Like most prescription medications, Yupelri can cause side effects, though not everyone experiences them. Most are mild and manageable, while serious reactions are rare.

Common side effects include:

  • Cough or throat irritation after inhalation
  • Headache
  • Runny or stuffy nose
  • Dry mouth

Less common or serious side effects:

  • Urinary retention (trouble urinating)
  • Fast or irregular heartbeat
  • Eye pain or blurred vision
  • Allergic reactions such as rash or swelling of the face or tongue

Patients with glaucoma, enlarged prostate, or bladder obstruction should use Yupelri with caution, as it may worsen these conditions.

Seek immediate medical attention if you experience sudden difficulty breathing, severe dizziness, or signs of an allergic reaction. However, most patients tolerate Yupelri well when used as prescribed under medical supervision (Mayo Clinic, 2024).

Yupelri dosage

Yupelri is supplied as a nebulized solution and is taken once daily using a standard jet nebulizer connected to an air compressor. Each dose should be inhaled slowly and deeply through the mouthpiece to ensure proper delivery to the lungs.

It is important not to mix Yupelri with other nebulized medications unless advised by your doctor. Patients should continue other COPD maintenance therapies such as inhaled corticosteroids or long-acting beta-agonists, if prescribed, as Yupelri is not a substitute for those drugs.

Because Yupelri acts locally in the lungs, routine blood tests are not usually required. However, your doctor may monitor lung function, heart rate, and overall symptom control during follow-up visits to ensure the medication is working effectively.

Older adults and those with kidney or liver impairment may require additional monitoring to avoid drug accumulation or side effects.

Does Yupelri have a generic version?

As of 2025, no generic version of Yupelri (revefenacin) is available in the United States. It is currently manufactured by Theravance Biopharma and Viatris.

Since it is still under patent protection, only the branded formulation is sold. However, Yupelri’s manufacturers often offer patient assistance programs or savings cards to help reduce out-of-pocket costs for eligible individuals.

Once a generic version becomes available, it will be held to the same FDA standards of safety, quality, and effectiveness as the brand-name product. Patients can discuss cost-saving options with their healthcare provider or pharmacist.

Conclusion

Yupelri represents a modern advancement in COPD management, offering a convenient, once-daily nebulized option for long-acting symptom control. By helping the airways stay open, it allows patients to breathe more freely, engage in daily activities, and experience a better quality of life.

Although it is not a cure for COPD, Yupelri can significantly reduce breathlessness and improve lung function when used consistently as part of a comprehensive treatment plan that includes lifestyle modifications and pulmonary rehabilitation.

As with all COPD therapies, regular follow-up with your healthcare provider is essential to ensure treatment remains safe and effective. Yupelri is a proven and well-tolerated medication when prescribed and monitored by a qualified medical professional, giving patients confidence in managing their condition and maintaining independence for the long term.

References

  1. U.S. Food and Drug Administration (FDA). (2024). Yupelri (revefenacin) Prescribing Information. https://www.fda.gov/
  2. Mayo Clinic. (2024). Chronic Obstructive Pulmonary Disease (COPD): Treatment Overview. https://www.mayoclinic.org/
  3. MedlinePlus. (2024). Revefenacin Inhalation: Drug Information. https://medlineplus.gov/
  4. National Institutes of Health (NIH). (2024). COPD: Current Pharmacologic Management. https://www.nih.gov/
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Brand Information

YUPELRI (revefenacin)
1INDICATIONS AND USAGE
YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
2DOSAGE AND ADMINISTRATION
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 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
The drug compatibility (physical and chemical), efficacy, and safety of YUPELRI when mixed with other drugs in a nebulizer have not been established.
3DOSAGE FORMS AND STRENGTHS
Inhalation solution: 175 mcg of revefenacin in 3 mL of sterile, clear, colorless, aqueous solution in unit dose vials.
4CONTRAINDICATIONS
YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.
5ADVERSE REACTIONS
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 [
5.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The YUPELRI safety database included 2,285 subjects with COPD in two 12-week efficacy studies and one 52-week long-term safety study. A total of 730 subjects received treatment with YUPELRI 175 mcg once daily. The safety data described below are based on the two 12-week trials and the one 52-week trial.
12-Week Trials
YUPELRI was studied in two 12-week replicate placebo-controlled trials in patients with moderate to very severe COPD (Trials 1 and 2). In these trials, 395 patients were treated with YUPELRI at the recommended dose of 175 mcg once daily.
The population had a mean age of 64 years (range from 41 to 88 years), with 50% males, 90% Caucasian, and had COPD with a mean post-bronchodilator forced expiratory volume in one second (FEV
Table 1 shows the most common adverse reactions that occurred with a frequency of greater than or equal to 2% in the YUPELRI group and higher than placebo in the two 12‑week placebo-controlled trials.
The proportion of subjects who discontinued treatment due to adverse reactions was 13% for the YUPELRI-treated subjects and 19% for placebo-treated subjects.
Other adverse reactions defined as events with an incidence of ≥1.0%, less than 2.0%, and more common than with placebo included the following: hypertension, dizziness, oropharyngeal pain, and bronchitis.
52-Week Trial
YUPELRI was studied in one 52-week, open-label, active-control (tiotropium 18 mcg once daily) trial in 1,055 patients with COPD. In this trial, 335 patients were treated with YUPELRI 175 mcg once daily and 356 patients with tiotropium. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled 12-week studies described, with the exception that concurrent LABA or LABA/ICS therapy was used in 50% of patients. The adverse reactions reported in the long-term safety trial for YUPELRI were consistent with those observed in the placebo-controlled studies of 12-weeks.
5.2Postmarketing Experience
The following adverse reaction has been reported during post-approval use of YUPELRI. Because this reaction was reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Dry mouth
6OVERDOSAGE
An overdosage of YUPELRI may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances, or reddening of the eye), obstipation or difficulties in voiding.
Treatment of overdosage consists of discontinuation of YUPELRI along with institution of appropriate symptomatic and/or supportive therapy.
7DESCRIPTION
YUPELRI is a sterile, clear, colorless, aqueous solution of revefenacin. Revefenacin, the active component of YUPELRI, is an anticholinergic. The chemical name for revefenacin is 1-(2-{4-[(4-carbamoylpiperidin-1-yl)methyl]-
Revefenacin Structural Formula
Revefenacin has a molecular weight of 597.76 and its empirical formula is C
YUPELRI is supplied as 3 mL of revefenacin solution packaged in a unit-dose low-density polyethylene vial overwrapped in a foil pouch. Each vial contains 175 mcg of revefenacin in 3 mL of an isotonic, sterile aqueous solution containing citric acid, sodium chloride, sodium citrate, and water for injection at pH 5.0. Hydrochloric acid or sodium hydroxide may be used to adjust the pH.
YUPELRI does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the nebulization system used, and compressor performance.
Using the PARI LC
8CLINICAL STUDIES
The safety and efficacy of YUPELRI 175 mcg once daily were evaluated in two dose‑ranging trials, two replicate 12-week, Phase 3 confirmatory clinical trials, and a 52-week safety trial. The efficacy of YUPELRI is primarily based on the two replicate 12-week, Phase 3 placebo-controlled trials in 1,229 subjects with COPD.
8.1Dose-Ranging Trials
Dose selection for YUPELRI was supported by a 28-day, randomized, double-blind, placebo-controlled, parallel-group trial of 355 subjects diagnosed with moderate to severe COPD, which was conducted to evaluate four doses of YUPELRI. YUPELRI 44, 88, 175, and 350 mcg, or matching placebo were taken once daily in the morning via a standard jet nebulizer (PARI LC
Evaluations of the dosing interval by comparing once- and twice-daily dosing of YUPELRI in a 7-day, randomized, double-blind, placebo-controlled, crossover trial in 64 patients supported selection of the once-daily dosing interval for further evaluation in the confirmatory COPD trials.
The dose-ranging results supported the evaluation of two doses of YUPELRI, 88 mcg and 175 mcg once daily, in the confirmatory COPD trials.
8.2Confirmatory Trials
The clinical development program for YUPELRI included two 12-week, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group, confirmatory trials in subjects with moderate to very severe COPD designed to evaluate the efficacy of once-daily YUPELRI’s effect on lung function (Trial 1: NCT02459080 and Trial 2: NCT02512510). To be enrolled, subjects needed to be 40 years of age or older, have a clinical diagnosis of COPD, a history of smoking greater than or equal to 10 pack-years, moderate to very severe COPD (post‑ipratropium FEV
Trials 1 and 2 evaluated YUPELRI 175 mcg once daily and placebo once daily. The primary endpoint was change from baseline in trough (predose) FEV
Table 2 presents the results from Trial 1 and Trial 2. The change from baseline in trough FEV
Figure 1: LS Mean Change from Baseline in Trough FEV1 (mL) over 12 weeks (Trial 1)
In Trial 1, serial spirometry over 24 hours was performed in a subset of patients (n=44 placebo, n=45 YUPELRI 175 mcg) on Day 84. In Trial 2, similar testing was also performed (n=39 placebo, n=44 YUPELRI 175 mcg). That data for Trial 1 is shown in Figure 2.
Figure 2: LS Mean Change from Baseline FEV1 (mL) over 24 Hours Day 84 (Trial 1 subset)
Peak FEV
The St. Georges Respiratory Questionnaire (SGRQ) was assessed in Trials 1 and 2. In Trial 1, the SGRQ responder rate (defined as an improvement in score of 4 or more as threshold) for the YUPELRI treatment arm on Day 85 was 49% compared to 34% for placebo [Odds Ratio: 2.11; 95% CI: 1.14, 3.92]. In Trial 2, the SGRQ responder rate for the YUPELRI treatment arm was 45% compared to 39% for placebo [Odds Ratio: 1.31; 95% CI: 0.72, 2.38].
9HOW SUPPLIED/STORAGE AND HANDLING
Inhalation solution: YUPELRI is supplied as a 175 mcg/3 mL sterile, clear, colorless, aqueous solution in unit-dose low‑density polyethylene vials. Each vial is overwrapped in a foil pouch and supplied in cartons containing either 30 individually pouched unit‑dose vials (NDC 49502-806-93) or 7 individually pouched unit-dose vials (NDC 49502-806-77).
Storage and Handling
  • 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) [See USP Controlled Room Temperature]. Protect from direct sunlight and excessive heat.
The YUPELRI solution 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.
  • Discard any solution that is not clear and colorless.
  • YUPELRI should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow, and equipped with a mouthpiece.
  • Do not swallow or inject YUPELRI.
10PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Not for Acute Symptoms
Inform patients that YUPELRI is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta
Instruct patients to seek medical attention immediately if they experience any of the following:
  • Decreasing effectiveness of inhaled, short-acting beta
  • Need for more inhalations than usual of inhaled, short-acting beta
  • Significant decrease in lung function as outlined by the physician
Tell patients they should not stop therapy with YUPELRI without healthcare provider guidance since symptoms may recur after discontinuation.
Paradoxical Bronchospasm
As with other inhaled medicines, YUPELRI can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue YUPELRI
Worsening of Narrow-Angle Glaucoma
Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g. eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develops
Worsening of Urinary Retention
Instruct patients to be alert for signs and symptoms of urinary retention (e.g. difficulty passing urine, painful urination). Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develops
Instructions for Administering YUPELRI
It is important for patients to understand how to correctly administer YUPELRI using a standard jet nebulizer
Patients should not inhale more than one dose at any one time. The daily dosage of YUPELRI should not exceed one unit-dose vial. Inform patients to use the contents of one vial of YUPELRI orally inhaled daily at the same time every day. Patients should throw the plastic dispensing vials away immediately after use. Due to their small size, the vials pose a danger of choking to young children.
The brands listed are trademarks of their respective owners.
Licensed from:
Manufactured for:
Made in USA
© 2021 Viatris Inc.
YUPELRI
Patented. See YUPELRI.com/ patents
11PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration.    Revised: 11/2021
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Licensed from:
Manufactured for:
Made in USA
© 2021 Viatris Inc.

YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris Company.
Patented.  See YUPELRI.com/patents
Revised: 5/2022
RPINXXXX
12PRINCIPAL DISPLAY PANEL – 175mcg/3 mL
NDC 49502-806-93
Rx only
YUPELRI
(revefenacin) inhalation solution
175 mcg/3 mL
For Oral Inhalation Only
30 sterile
unit-dose vials
Contents:
Each vial contains 175 mcg of revefenacin in an isotonic, sterile aqueous solution containing sodium chloride, citric acid and sodium citrate. Hydrochloric acid or sodium hydroxide may be used to adjust the pH.
Storage:
Store YUPELRI (revefenacin) inhalation solution 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) [See USP Controlled Room Temperature]. Protect from direct sunlight and excessive heat. 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. Discard any solution that is not clear and colorless. Use only as directed by your healthcare provider.
Keep out of reach of children. Not a child-resistant package.
Manufactured for:
Licensed from:
TRC:806:30C:R3
© 2021 Viatris Inc.
YUPELRI and the YUPELRI logo are registered trademarks of Mylan Specialty L.P., a Viatris Company.
THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies.
Patented. See YUPELRI.com/patents
Yupelri Inhalation Solution 175 mcg/3 mL Carton Label