Umeclidinium and Vilanterol

Umeclidinium/vilanterol is a prescription medication used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).

This medication is a combination of umeclidinium, an inhaled anticholinergic that affects the muscles around the large airways and stops the muscles from tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) that improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs.

Umeclidinium/vilanterol comes as an inhaler to be inhaled into the lungs, once daily.

The most common side effects reported include sore throat, sinus infection, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of umeclidinium/vilanterol is 1 inhalation once daily inhaled orally.

• People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol, have an increased risk of death from asthma problems. 
• It is not known if LABA medicines, such as vilanterol, increase the risk of death in people with COPD. 
• Call your healthcare provider if breathing problems worsen over time while using umeclidinium/vilanterol. You may need different treatment.

• Sudden breathing problems immediately after inhaling your medicine 
• 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 
  • swelling of the face, mouth, and tongue 
  • breathing problems 
• Effects on your heart
  • increased blood pressure 
  • a fast and/or irregular heartbeat 
  • chest pain 
• Effects on your nervous system 
  • tremor 
  • nervousness 
• 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: 
  • eye pain or discomfort 
  • nausea or vomiting 
  • blurred vision 
  • seeing halos or bright colors around lights 
  • red eyes 
• Urinary retention. People who take umeclidinium/vilanterol may develop new or worse urinary retention. Symptoms of urinary retention may include: 
  • difficulty urinating 
  • painful urination 
  • urinating frequently 
  • urination in a weak stream or drips 
• Changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) 

Get emergency medical care if: 

• your breathing problems worsen quickly 
• you use your rescue inhaler, but it does not relieve you

Do not use umeclidinium/vilanterol if you: 

• have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure. 
• are allergic to umeclidinium, vilanterol, or any of the ingredients in this medication

Serious side effects have been reported. See "Precautions".

• sore throat 
• sinus infection   
• lower respiratory infection 
• common cold symptoms 
• constipation 
• diarrhea 
• pain in your arms or legs 
• muscle spasms 
• neck pain 
• chest pain 

Tell your healthcare provider about any side effect that bothers you or that does not go away. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

• anticholinergics (including tiotropium, ipratropium, aclidinium) 
• atropine 

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no good studies that have been done in humans with umeclidinium/vilanterol. However, animal reproduction studies demonstrated no evidence of adverse effects. Because animal reproduction studies are not always predictive of human response, this medication should be used during pregnancy only if the potential benefit justifies the potential risk.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if umeclidinium/vilanterol passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking this medication.

Call your healthcare provider if breathing problems worsen over time while using umeclidinium/vilanterol. You may need different treatment.

Umeclidinium/vilanterol does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

Umeclidinium/vilanterol may cause a change in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).

Safely throw away umeclidinium/vilanterol in the trash 6 weeks after you open the foil tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler.