Revefenacin (rev-e-FEN-a-sin)

Treats chronic obstructive pulmonary disease (COPD).

Brand Name(s):

Yupelri

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Your doctor or other health caregiver should show you how to use this medicine. Use it at the same time every day. Do not use more medicine or use it more often than instructed.
• To use this medicine:
  • Use the vials only in a standard jet nebulizer machine with a mouthpiece connected to an air compressor. Do not swallow or inject the liquid in the vial. Do not mix this medicine with any other medicine in your nebulizer.
  • Do not remove the vial from the sealed pouch until you are ready to use it. Use the vial right away once you have opened the pouch.
  • Check the liquid in the vial. It should be clear and colorless. Do not use it if it is discolored.
  • Squeeze all of the medicine from the vial into the nebulizer cup.
  • Connect the mouthpiece to the nebulizer cup with the expiratory valve facing up.
  • Insert one end of the tubing to the compressor and the other end to the bottom of the nebulizer cup.
  • Sit in an upright position. Place the mouthpiece in your mouth and close your lips around it. Turn on the compressor.
  • Take one long, steady, deep breath in through your mouth until no more mist is seen in the nebulizer cup. Your treatment will take about 8 minutes and will end when you do not see any mist in the nebulizer anymore. Turn the compressor off.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not use more than 1 vial per day.
• Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how revefenacin works. Tell your doctor if you are using atropine, cyclosporine, or rifampicin. Also tell your doctor if you take other medicines that can cause dry mouth or constipation (including aclidinium, glycopyrrolate, ipratropium, tiotropium, or umeclidinium).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, kidney disease, glaucoma, an enlarged prostate, bladder problems, or trouble urinating.
• This medicine may cause paradoxical bronchospasm (increased trouble breathing), which can be life-threatening.
• Do not use this medicine for a sudden COPD attack. Make sure you always have your rescue medicine with you to treat sudden symptoms. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, eye pain, seeing halos around objects
• Change in how much or how often you urinate, difficult or painful urination
• Increased trouble breathing

If you notice other side effects that you think are caused by this medicine, tell your doctor

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