IMPORTANT SAFETY INFORMATION

Do not use ARNUITY ELLIPTA to treat sudden symptoms of asthma. ARNUITY is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always have a rescue inhaler, such as albuterol, with you to treat sudden symptoms. See full Important Safety Information below

FAQs: Learn more about ARNUITY ELLIPTA and asthma

Here are answers to some frequently asked questions about ARNUITY ELLIPTA and asthma.

ARNUITY ELLIPTA is an inhaled corticosteroid (ICS) medicine taken as 1 inhalation, once daily, for the control and prevention of asthma in adults and children aged 12 years and older.

  • ARNUITY ELLIPTA helps to prevent and control symptoms of asthma.
  • ARNUITY ELLIPTA is not for use to treat sudden symptoms of an asthma attack, wheezing, cough, shortness of breath, and chest pain or tightness. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
  • It is not known if ARNUITY ELLIPTA is safe and effective in children younger than 12 years.

Do not use ARNUITY ELLIPTA:

  • to treat sudden symptoms of asthma. ARNUITY ELLIPTA is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler, such as albuterol, during a sudden asthma attack.
  • if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • if you are allergic to fluticasone furoate or any of the ingredients in ARNUITY ELLIPTA. See “What are the ingredients in ARNUITY ELLIPTA?” below for a complete list of ingredients.

In clinical studies, ARNUITY ELLIPTA once daily has been proven to improve breathing for a full 24 hours, based on lung function measurements taken over the course of 24 hours following the last dose of ARNUITY ELLIPTA. Your results may vary.

In clinical studies, patients using ARNUITY ELLIPTA had more days without the need for a rescue inhaler (albuterol). Your results may vary.

Active ingredients: fluticasone furoate

Inactive ingredients: lactose monohydrate (contains milk proteins)

Tell your healthcare provider about all of your health conditions, including if you:

  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in ARNUITY ELLIPTA, any other medicines, or food products.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if ARNUITY ELLIPTA may harm your unborn baby.
  • are breastfeeding. It is not known if the medicine in ARNUITY ELLIPTA passes into your 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. ARNUITY ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal, anti-HIV, or any other corticosteroid medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

ARNUITY ELLIPTA can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ARNUITY ELLIPTA to help reduce your chance of getting thrush.
  • weakened immune system and increased chance of getting infections (immunosuppression)
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as ARNUITY ELLIPTA). When your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse asthma 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
  • 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
  • bone thinning or weakness (osteoporosis)
  • slow growth in adolescents. An adolescent’s growth should be checked often.
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using ARNUITY ELLIPTA.

Common side effects of ARNUITY ELLIPTA include:

  • runny nose and sore throat
  • headache
  • breathing problems (bronchitis)
  • flu

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

These are not all the side effects with ARNUITY ELLIPTA. Ask your healthcare provider or pharmacist for more information.

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 ARNUITY ELLIPTA at the end of the Patient Information that comes with your medicine.

  • Do not use ARNUITY ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • ARNUITY ELLIPTA comes in 2 different strengths. Your healthcare provider prescribed the strength that is best for you.
  • Use ARNUITY ELLIPTA exactly as your healthcare provider tells you to use it. Do not use ARNUITY ELLIPTA more often than prescribed.
  • Adolescents may need help to use ARNUITY ELLIPTA.
  • Use 1 inhalation of ARNUITY ELLIPTA 1 time each day. Use ARNUITY ELLIPTA at the same time each day.
  • If you miss a dose of ARNUITY ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation each day. Take your next dose at your usual time. Do not take 2 doses at one time.
  • Do not stop using ARNUITY ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • ARNUITY ELLIPTA 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.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse
    • you need to use your rescue inhaler more often than usual
    • your rescue inhaler does not work as well to relieve your symptoms
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row
    • you use 1 whole canister of your rescue inhaler in 8 weeks
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • Store ARNUITY ELLIPTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store ARNUITY ELLIPTA in the unopened foil tray and only open when ready for use.
  • Safely throw away ARNUITY ELLIPTA 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.
  • Keep ARNUITY ELLIPTA and all medicines out of the reach of children.

Yes, you may be eligible to get your first 30-day prescription for free and/or pay no more than $10 a month on your prescription for ARNUITY ELLIPTA for 12 months. To find out if you qualify, read the Eligibility Requirements.

Asthma is a serious lung disease, and inflammation of your airways is a major factor. Inflammation can make your airways more sensitive and more narrow than usual, making it harder to breathe. If the inflammation caused by your asthma isn’t treated correctly, your symptoms may get worse. It is important to monitor your symptoms so that you can recognize when they are getting worse.

Some days you may feel great, with no symptoms at all. That doesn't mean your asthma has gone away. You can't cure asthma, but working along with your healthcare provider, you can learn to manage it. Learning how to manage your asthma may help you keep it under control.

IMPORTANT SAFETY INFORMATION

  • Do not use ARNUITY ELLIPTA to treat sudden symptoms of asthma. ARNUITY is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always have a rescue inhaler, such as albuterol, with you to treat sudden symptoms.
  • Do not use ARNUITY if you have a severe allergy to milk proteins or are allergic to any of the ingredients in ARNUITY. Ask your healthcare provider if you are not sure.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • Do not use ARNUITY more often than prescribed.
  • Do not stop using ARNUITY unless your healthcare provider tells you to. If you miss a dose of ARNUITY, take it as soon as you remember. Do not take more than 1 inhalation each day. Take your next dose at your usual time.
  • ARNUITY can cause serious side effects, including:
    • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ARNUITY to help reduce your chance of getting thrush.
    • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. 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 ARNUITY). When your body is under stress, such as from fever, trauma (such as a car accident), infection, surgery, or worse asthma 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
    • 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
    • bone thinning or weakness (osteoporosis)
    • slow growth in adolescents. An adolescent's growth should be checked often.
    • eye problems, including glaucoma and cataracts. You should have regular eye exams while using ARNUITY.
  • Common side effects of ARNUITY include:
    • runny nose and sore throat
    • headache
    • breathing problems (bronchitis)
    • flu

IMPORTANT SAFETY INFORMATION