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Full Prescribing Information
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 * Efficacy and Safety
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When symptom relief is consistent, each day has possibilities.*
LEARN MORE

*For patients with COPD who seek symptom relief, YUPELRI is the first and only
once-daily nebulized LAMA for a full 24 hours of lung function improvement.1

YUPELRI was studied in a two 12-week, randomized, double-blind,
placebo-controlled, parallel-group confirmatory studies of once-daily YUPELRI in
patients with moderate to very severe COPD. The primary endpoint was change from
baseline in trough (predose ) FEV1 at day 85 vs placebo: YUPELRI demonstrated a
statistically significant difference vs placebo in both studies. In addition, a
prespecified exploratory analysis was performed using serial spirometry on a
substudy population over 24 hours on days 84 /85, which showed consistent
improvement in FEV1 versus placebo over 24 hours. See results here.

Use the  icon to expand each subject area.

Why nebulization?

Who is the right patient?

Why YUPELRI?


HAVE YOU CONSIDERED THE ROLE OF NEBULIZATION IN COPD MAINTENANCE THERAPY?



Nebulizers: a user-friendly option for COPD patients2

 * Nebulizers require only normal tidal breathing and do not require generating
   adequate inspiratory force3-5
 * No hand-breath coordination is needed3,6
 * Today's nebulizers include compact, portable, and low cost options for most
   patients7,20



LEARN MORE


MANY OF YOUR PATIENTS MAY BE CANDIDATES FOR NEBULIZED THERAPY



Consider nebulized therapy for appropriate patients.



LEARN MORE

YUPELRI delivers consistent control* over 12 weeks.

YUPELRI demonstrated consistent improvements† in trough FEV1 vs placebo over the
12-week study period.1,11

*In Study 1, LS mean change from baseline in trough FEV1 on day 85 was 127 mL
(YUPELRI, n=189) and -19 mL (placebo, n=191), with a statistically significant
difference vs placebo of 146 mL (P<.0001). In Study 2, LS mean change from
baseline in trough FEV1 on day 85 was 102 mL (YUPELRI, n=181) and -45 mL
(placebo, n=187), with a statistically significant difference of 147 mL
(P<.0001).11 †The first measurement was taken at 2 weeks.



LEARN MORE

Why nebulization?

Who is the right patient?

Why YUPELRI?



PROVEN 24-HOUR CONTROL1

Responses as early as 30 minutes*

VIEW CLINICAL DATA

ONCE-DAILY DOSING1

Administered with any standard jet nebulizer with a mouthpiece

Learn About Dosing And Administration

DEMONSTRATED SAFETY PROFILE1

Fewer discontinuations with YUPELRI (13%) vs placebo (19%)1

VIEW SAFETY PROFILE DATA

*An exploratory analysis of the time to achieve a 100-mL increase in FEV1 on day
1 showed that the median time to achieve an increase in FEV1 of 100 mL was 30
minutes in Study 1 (30 to 60 minutes) and Study 2 (30 to 90 minutes).

UP TO 100% OF PATIENTS WITH MEDICARE PART B ARE COVERED.† J-CODE J7677 LEARN
MORE

†This is not a guarantee of coverage. Site of Care will determine coverage.
Check with your patient’s insurance provider for coverage rules and
restrictions. In certain limited instances, YUPELRI may be covered through a
patient’s Medicare Part D pharmacy benefit.

INDICATION

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YUPELRI® inhalation solution is indicated for the maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD).


IMPORTANT SAFETY INFORMATION

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

YUPELRI should not be initiated in patients during acutely deteriorating or
potentially life-threatening episodes of COPD, or for the relief of acute
symptoms, i.e., as rescue therapy for the treatment of acute episodes of
bronchospasm. Acute symptoms should be treated with an inhaled short-acting
beta2-agonist.

YUPELRI® inhalation solution is indicated for the maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD).


IMPORTANT SAFETY INFORMATION

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

YUPELRI should not be initiated in patients during acutely deteriorating or
potentially life-threatening episodes of COPD, or for the relief of acute
symptoms, i.e., as rescue therapy for the treatment of acute episodes of
bronchospasm. Acute symptoms should be treated with an inhaled short-acting
beta2-agonist.

As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm
that may be life-threatening. If paradoxical bronchospasm occurs following
dosing with YUPELRI, it should be treated immediately with an inhaled,
short-acting bronchodilator. YUPELRI should be discontinued immediately and
alternative therapy should be instituted.

YUPELRI should be used with caution in patients with narrow-angle glaucoma.
Patients should be instructed to immediately consult their healthcare provider
if they develop any signs and symptoms of acute narrow-angle glaucoma, including
eye pain or discomfort, blurred vision, visual halos or colored images in
association with red eyes from conjunctival congestion and corneal edema.

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 after administration of YUPELRI.
If a reaction occurs, YUPELRI should be stopped at once and alternative
treatments considered.

The most common adverse reactions occurring in clinical trials at an incidence
greater than or equal to 2% in the YUPELRI group, and higher than placebo,
included cough, nasopharyngitis, upper respiratory infection, headache and back
pain.

Coadministration of anticholinergic medicines or OATP1B1 and OATP1B3 inhibitors
with YUPELRI is not recommended.

YUPELRI is not recommended in patients with any degree of hepatic impairment.

For additional information please contact us at 1-800-395-3376.

INDICATION

YUPELRI® inhalation solution is indicated for the maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD).

IMPORTANT SAFETY INFORMATION

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

YUPELRI should not be initiated in patients during acutely deteriorating or
potentially life-threatening episodes of COPD, or for the relief of acute
symptoms, i.e., as rescue therapy for the treatment of acute episodes of
bronchospasm. Acute symptoms should be treated with an inhaled short-acting
beta2-agonist.

As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm
that may be life-threatening. If paradoxical bronchospasm occurs following
dosing with YUPELRI, it should be treated immediately with an inhaled,
short-acting bronchodilator. YUPELRI should be discontinued immediately and
alternative therapy should be instituted.

YUPELRI should be used with caution in patients with narrow-angle glaucoma.
Patients should be instructed to immediately consult their healthcare provider
if they develop any signs and symptoms of acute narrow-angle glaucoma, including
eye pain or discomfort, blurred vision, visual halos or colored images in
association with red eyes from conjunctival congestion and corneal edema.

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 after administration of YUPELRI.
If a reaction occurs, YUPELRI should be stopped at once and alternative
treatments considered.

The most common adverse reactions occurring in clinical trials at an incidence
greater than or equal to 2% in the YUPELRI group, and higher than placebo,
included cough, nasopharyngitis, upper respiratory infection, headache and back
pain.

Coadministration of anticholinergic medicines or OATP1B1 and OATP1B3 inhibitors
with YUPELRI is not recommended.

YUPELRI is not recommended in patients with any degree of hepatic impairment.

For additional information please contact us at 1-800-395-3376.


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YUPELRI and the Yupelri Logo are registered trademarks of Mylan Specialty L.P.,
a Viatris Company. VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a
Viatris Company.
THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered
trademarks of the Theravance Biopharma group of companies (in the U.S. and
certain other countries).
PARI TREK and PARI LC SPRINT are registered trademarks of PARI GmbH.

© 2022 Viatris Inc. All Rights Reserved. REV-2021-0101 v3



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