Yupelri

What is Yupelri?

• Yupelri is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
• Yupelri is an anticholinergic medicine. Anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.
• Yupelri 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.
• Yupelri is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine.
• Yupelri should not be used in children. It is not known if Yupelri is safe and effective in children.

What is the most important information I should know about Yupelri?

Yupelri is for oral inhalation only. Do not swallow or inject Yupelri.

Who should not use Yupelri?

Do not use Yupelri if you have had an allergic reaction to revefenacin or any of the ingredients in Yupelri. Ask your healthcare provider if you are not sure. See below for a complete list of ingredients in Yupelri.

What should I tell my healthcare provider before using Yupelri?

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. See “What are the ingredients in Yupelri?” below for a complete list of ingredients.
• are pregnant or plan 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 anticholinergic medicines (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.

How should I use Yupelri?

Read the step-by-step instructions for using Yupelri below.

• Yupelri is only for use with a nebulizer.
• Do not use Yupelri unless your healthcare provider has taught you how to use it with your nebulizer and you understand how to use it correctly.
• Use Yupelri exactly as your healthcare provider tells you to use it. Do not use Yupelri more often than prescribed.
• Yupelri is taken as a breathing treatment (by oral inhalation) and should be used with a standard jet nebulizer with a mouthpiece connected to an air compressor.
• Do not mix Yupelri with other medicines in your nebulizer.
• Use 1 vial of Yupelri, 1 time each day. Do not use more than 1 vial of Yupelri a day.
• Use Yupelri at the same time each day.
• If you use too much Yupelri, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, or increased heart rate.
• Do not use other medicines that contain an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are anticholinergic medicines.
• Yupelri does not relieve sudden symptoms of COPD and you should not use extra doses of Yupelri to relieve these sudden symptoms. Always have an inhaled rescue medicine with you to treat sudden symptoms. If you do not have an inhaled rescue medicine, call your healthcare provider to have one prescribed for you.
• 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 inhaled rescue medicine more often than usual.
  • your inhaled rescue medicine does not relieve your symptoms.

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 of acute narrow-angle glaucoma may include:
  • red eyes
  • blurred vision
  • seeing halos or bright colors around lights
  • eye pain or discomfort
  • nausea or vomiting
    If you have any of these symptoms, call your healthcare provider right away before using another dose of Yupelri.
• Urinary retention. People who use 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 using another dose of Yupelri.
• Serious allergic reactions. See “Who should not use Yupelri?”
  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

Common side effects of Yupelri include:

• cough
• runny nose
• upper respiratory tract infection
• headache
• back pain

These are not all the possible side effects of Yupelri.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088.

General Information about the safe and effective use of Yupelri

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Yupelri for a condition for which it was not prescribed. Do not give Yupelri to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Yupelri that is written for health professionals.

How should I store Yupelri?

• Store Yupelri at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Yupelri in the unopened protective foil pouch and only open the foil pouch right before you are ready to use Yupelri.
• Keep Yupelri away from light and heat.
• Throw away the vial of Yupelri and any leftover medicine after use.
• Throw away the vial of Yupelri if the solution is not clear and colorless.
• Do not use Yupelri after the expiration date provided on the foil pouch and vial.
• Keep Yupelri and all medicines out of the reach of children.

What are the ingredients in Yupelri?

Active ingredient: revefenacin

Inactive ingredients: sodium chloride, citric acid, sodium citrate, and water for injection. Hydrochloric acid or sodium hydroxide may be used to adjust the pH.

For more information about Yupelri, go to WWW.YUPELRI.COM or call 1-877-446-3679 (1-877-4-INFO-RX).

Instructions for use for Yupelri

Yupelri (you-PELL-ree)
(revefenacin)
inhalation solution, for oral inhalation

Yupelri is used only in a standard jet nebulizer machine with a mouthpiece connected to an air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in Yupelri or other medicines.

Important Information:

• Do not mix Yupelri with other medicines in your nebulizer.
• 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.

Using Yupelri:

Read the following Steps before using Yupelri. If you have any questions, ask your healthcare provider or pharmacist.

Step 1. Open Pouch: Open the foil pouch by tearing along the seam of the pouch. Remove the vial of Yupelri from the foil pouch (Figure 1).

Step 2. Open Vial: Carefully twist open the top of the vial and use it right away (Figure 2).

Step 3. Add Medicine: Squeeze all of the medicine from the vial into the nebulizer cup (reservoir) (Figure 3).

Step 4. Attach Mouthpiece: Connect the mouthpiece to the nebulizer cup (reservoir) with the expiratory valve facing up (Figure 4).

Step 5. Connect the Nebulizer to the Compressor: Firmly insert one end of the tubing to the compressor. Insert the other end of the tubing to the bottom of the nebulizer cup (reservoir) (Figure 5).

Step 6. Prepare for Treatment: Sit in a comfortable, upright position. Place the mouthpiece in your mouth and close your lips around the mouthpiece.

Step 7. Begin Treatment: Turn on the compressor to begin your treatment (Figure 6).

Step 8. Breathe in Medicine: 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.

Step 9. Clean Nebulizer: Clean and store your nebulizer. See the manufacturer’s instructions that come with your nebulizer for how to clean and store your nebulizer.

Instructions for use revised 05/2022.