Yupelri (revefenacin)

• 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.

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. 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.

• Read the step-by-step instructions for using Yupelri that comes with the product.
• 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.

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. 

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 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.