About ANORO ELLIPTA

Why ANORO

Once-daily ANORO is a prescription medicine used long term to treat COPD for better breathing. ANORO is not used to treat sudden COPD symptoms and won't replace a rescue inhaler. ANORO is not for asthma.

  1. ANORO contains two medicines that work together to significantly improve lung function all day and all night. Results may vary.
  2. ANORO is a one inhalation, once-daily medication that helps keep airways open to improve COPD symptoms for better breathing.
  3. ANORO helped more COPD patients experience a meaningful improvement in health-related quality of life. In clinical studies, patients completed a disease-specific questionnaire called the St. George's Respiratory Questionnaire. They answered questions about their symptoms, activities, and impact on daily life. More patients taking ANORO had an improvement in total score on the questionnaire than those who were not taking ANORO (received placebo). Results may vary.
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ANORO improved lung function more than SPIRIVA and more than ADVAIR.

Results shown in 2 of 3 clinical trials with SPIRIVA HANDIHALER. Individual results may vary. SPIRIVA contains 1 long-acting bronchodilator and is used to treat COPD and reduce COPD flare-ups. ANORO is not approved to reduce COPD flare-ups. Each product has its own risks and benefits. Please see full Important Safety Information for ANORO ELLIPTA below.

SPIRIVA and HANDIHALER are registered trademarks owned by Boehringer lngelheim.

Results shown in 2 clinical trials with ADVAIR DISKUS 250/50. Individual results may vary. ADVAIR contains an inhaled corticosteroid and a long-acting bronchodilator, and it is used to treat COPD and reduce COPD flare-ups. ANORO is not approved to reduce COPD flare-ups. Each product has its own risks and benefits.

If you have COPD, talk to your doctor to see if ANORO is right for you.

Important Safety Information for ADVAIR DISKUS® 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) below

APPROVED USES FOR ADVAIR DISKUS 250/50 FOR COPD

Twice-daily ADVAIR DISKUS 250/50 is a prescription medicine used long term to treat COPD for better breathing and fewer flare-ups. ADVAIR is not used to relieve sudden breathing problems and won't replace a rescue inhaler.

IMPORTANT SAFETY INFORMATION FOR ADVAIR DISKUS 250/50

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with LABA medicines, such as salmeterol.
  • It is not known if LABA medicines, such as salmeterol, increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly
    • you use your rescue inhaler, but it does not relieve your breathing problems.
  • Do not use ADVAIR DISKUS to treat sudden breathing problems from asthma or COPD. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use ADVAIR DISKUS if you have a severe allergy to milk proteins or are allergic to any of the ingredients in ADVAIR DISKUS. Ask your healthcare provider if you are not sure.
  • Do not use ADVAIR DISKUS more often than prescribed.
  • Do not take ADVAIR DISKUS with other medicines that contain a LABA for any reason.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • ADVAIR DISKUS can cause serious side effects, including:
    • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.
    • pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
      • increase in mucus (sputum) production
      • change in mucus color
      • fever
      • chills
      • increased cough
      • increased breathing problems
    • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
    • reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as ADVAIR DISKUS). During this transition period, when your body is under stress, such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
      • feeling tired
      • lack of energy
      • weakness
      • nausea and vomiting
      • low blood pressure
    • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ADVAIR DISKUS and call your healthcare provider right away.
    • 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 your face, mouth, and tongue
      • breathing problems
    • effects on heart
      • increased blood pressure
      • a fast or irregular heartbeat
      • chest pain
    • effects on nervous system
      • tremor
      • nervousness
    • bone thinning or weakness (osteoporosis)
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
    • changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
  • Common side effects of ADVAIR DISKUS 250/50 for COPD include:
    • thrush in your mouth or throat
    • throat irritation
    • hoarseness and voice changes
    • viral respiratory infections
    • headache
    • muscle and bone pain
  • Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.

IMPORTANT SAFETY INFORMATION FOR ANORO ELLIPTA

  • ANORO is only approved for use in COPD. ANORO is NOT approved for use in asthma.
  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in ANORO), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.

IMPORTANT SAFETY INFORMATION FOR ANORO ELLIPTA

  • ANORO is only approved for use in COPD. ANORO is NOT approved for use in asthma.
  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in ANORO), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using ANORO.
  • Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems.
  • Do not use ANORO to treat sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • ANORO is not for the treatment of asthma. It is not known if ANORO is safe and effective in people with asthma.
  • Do not use ANORO if you have a severe allergy to milk proteins or any of the ingredients in ANORO. Ask your healthcare provider if you are not sure.
  • Do not use ANORO more often than prescribed.
  • Do not take ANORO with other medicines that contain a LABA or an anticholinergic for any reason. Tell your healthcare provider about all the medicines you take and about all of your health conditions. Especially tell your healthcare provider if you take anticholinergics, including tiotropium, ipratropium, aclidinium, or atropine.
  • ANORO 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 ANORO and call your healthcare provider right away.
    • 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 your face, mouth, and tongue
      • breathing problems
    • effects on heart
      • increased blood pressure
      • a fast or irregular heartbeat, awareness of heartbeat
      • chest pain
    • effects on 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

      If you have these symptoms, call your healthcare provider right away before taking another dose.
    • urinary retention. People who take ANORO 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

      If you have these symptoms of urinary retention, stop taking ANORO and call your healthcare provider right away before taking another dose.
    • changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)
  • Common side effects of ANORO include:
    • sore throat
    • sinus infection
    • lower respiratory infection
    • common cold symptoms
    • constipation
    • diarrhea
    • pain in your arms or legs
    • muscle spasms
    • neck pain
    • chest pain
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.