Taking YUPELRI

RUTHIE:
I don’t have time for my COPD—or my COPD treatment—to interrupt my day. I have things to do, from start to finish. So I treat my COPD once a day, every day, with YUPELRI.

NARRATOR:
YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term chronic lung disease that includes chronic bronchitis, emphysema, or both.

RUTHIE:
With YUPELRI, I can get back to a full 24 hours of better breathing.

NARRATOR:
Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you. Do not use YUPELRI if you have had an allergic reaction to revefenacin or any of the other ingredients in YUPELRI.

Do not use in children. It is not known if YUPELRI is safe and effective in children.

YUPELRI is the first and only once-daily, nebulized treatment for COPD. Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you have glaucoma or prostate or bladder problems, including problems passing urine. YUPELRI can make these problems worse.

Tell your doctor if you have liver problems or have ever had an allergic reaction to revefenacin or any of its ingredients.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Each treatment is taken in a single dose to conveniently fit into your daily routine.

Tell your doctor about all of the medicines you take including over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other and cause serious side effects. It is important to tell your doctor if you take other anticholinergic medications or atropine.

In this video, we will demonstrate how to use YUPELRI with any standard jet nebulizer with a mouthpiece, like the PARI LC SPRINT^® nebulizer you see here. Before you start your first treatment, watch this video and remember to read the Instructions For Use in the Full Prescribing Information.

YUPELRI is used only in a standard jet nebulizer with a mouthpiece connected to an air compressor. Make sure you know how to use your nebulizer before you use it to breathe in YUPELRI or other medicines. Do not mix YUPELRI with other medicines in your nebulizer. Do not stop using YUPELRI, even if you are feeling better, unless instructed by your healthcare provider.

YUPELRI comes in a vial that is sealed in a foil pouch. Do not open the sealed pouch until you are ready to use a dose of YUPELRI. Use your YUPELRI right away after opening.

Ready to start?

First, open the sealed foil pouch along the seam and take out the vial of YUPELRI.

Carefully twist off the top of the vial and squeeze all the medicine from the vial into the nebulizer cup, also called a reservoir.

Then connect the mouthpiece to the nebulizer reservoir with the expiratory valve facing up. Like this.

Now you’re ready to connect the nebulizer to the air compressor. Firmly insert one end of the tubing into the compressor and the other end of the tubing into the bottom of the nebulizer cup.

Sit in an upright position. Place the mouthpiece in your mouth and turn the compressor on to begin your treatment.

Now, breathe as calmly, deeply, and evenly as possible until no more mist is seen in the nebulizer reservoir. Your treatment will take about 8 minutes. When you do not see any mist in the nebulizer, your treatment is finished. Turn the compressor off.

Just breathe as calmly, deeply, and evenly as possible and your nebulizer will get the medicine into your lungs, where it needs to go. YUPELRI requires about 8 minutes of nebulization time, which equals 24 hours of better breathing. Setup and cleanup time is also required.

When you are finished, turn the compressor off.

Cleaning the nebulizer is easy. Just wash the nebulizer parts with warm water and liquid dish soap, then rinse. Some pieces can also be placed on the top rack of the dishwasher. Just follow the manufacturer’s instructions.

That’s it! You’re done for the day.

RUTHIE:
Now I’m ready to go on with my day.

NARRATOR:
We hope this video made it easy to understand how to use YUPELRI with your nebulizer. With a once-daily treatment option, you may enjoy fewer interruptions in your day. Speak to your doctor to see if YUPELRI is right for you.

Remember to use YUPELRI as instructed and follow up with your doctor with any additional questions.

Please stay tuned for more important information about YUPELRI.

What is YUPELRI?

• YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
• It is an anticholinergic medicine which helps the muscles around the airway in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.
• It is used long-term as 1 vial of YUPELRI, 1 time each day inhaled through your nebulizer to improve symptoms of COPD for better breathing.

Who should not use YUPELRI?

• Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you.
• Do not use YUPELRI if you have had an allergic reaction to revefenacin, or any of the other ingredients in YUPELRI (sodium chloride, citric acid, sodium citrate).
• Do not use in children. It is not known if YUPELRI is safe and effective in children.

Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you:

• have eye problems such as glaucoma. YUPELRI may make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. YUPELRI may make these problems worse.
• have liver problems.
• are allergic to any of the ingredients in YUPELRI, or any other medicines.
• are pregnant or planning to become pregnant. It is not known if YUPELRI may harm your unborn baby.
• are breastfeeding. It is not known if the medicine in YUPELRI passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take:

• Other anticholinergics (including tiotropium, ipratropium, aclidinium, umeclidinium, glycopyrrolate)
• Atropine

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

What are the possible side effects with YUPELRI?

YUPELRI can cause serious side effects, including:

• Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away.
• New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include:
  • Red eyes
  • Blurred vision
  • Seeing halos or bright colors around lights
  • Eye pain or discomfort
  • Nausea or vomiting
• Urinary retention. People who take YUPELRI may develop new or worse urinary retention. Symptoms of urinary retention may include:
  • difficulty urinating
  • urinating frequently
  • urination in a weak stream or drips
  • painful urination

If you have any of these symptoms, call your healthcare provider right away before taking another dose.

• Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • severe itching
  • swelling of your face, mouth, and tongue
  • difficulty breathing or swallowing

If you have any of these symptoms, stop taking YUPELRI, and call your healthcare provider right away before taking another dose.

Common side effects of YUPELRI include:

• Cough
• Runny nose
• Upper respiratory tract infection
• Headache
• Back pain

Tell your healthcare provider if you get any side effects that bother you or that do not go away. These are not all the possible side effects with YUPELRI. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I use YUPELRI?

Read the step-by-step instructions for using YUPELRI at the end of this Patient Information Leaflet.

• YUPELRI is only for use with a nebulizer.
• Do not use YUPELRI more often than prescribed.
• Do not mix YUPELRI with other medicines in your nebulizer.
• Do not use other medicines that contain an anticholinergic for any reason.
• Do not stop using YUPELRI, even if you are feeling better, unless your healthcare provider tells you to because your symptoms might get worse.
• Call your healthcare provider or get emergency medical care right away if
  • your breathing problems get worse.
  • you need to use your rescue inhaler medicine more often than usual.
  • your rescue inhaler medicine does not relieve your symptoms.

This summary does not include all the information about YUPELRI and is not meant to take the place of a discussion with your healthcare provider about your treatment.

Once-daily YUPELRI. Because every moment matters.