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

Please review this safety information for ARNUITY.

Below you can learn about the risks and side effects of ARNUITY ELLIPTA. This, however, is not all the safety information, and does not replace talking to your healthcare professional about your medical condition or treatment. Please see the full Prescribing Information and Patient Information Leaflet for ARNUITY ELLIPTA for more information, or ask your healthcare provider or pharmacist.

Who should not use ARNUITY ELLIPTA?

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 below for "What are the ingredients in ARNUITY ELLIPTA?"

What should I tell my healthcare provider before using ARNUITY ELLIPTA?

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. See below for "What are the ingredients in ARNUITY ELLIPTA?"
  • 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.

What are the possible side effects with ARNUITY ELLIPTA?

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.

How do I store ARNUITY ELLIPTA?

  • 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.

What are the ingredients in ARNUITY ELLIPTA?

Active ingredients: fluticasone furoate Inactive ingredients: lactose monohydrate (contains milk proteins)

APPROVED USE

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

  • ARNUITY helps to prevent and control symptoms of asthma.
  • ARNUITY is not for use to treat sudden symptoms of an asthma attack, wheezing, cough, shortness of breath, and chest pain or tightness. ARNUITY won't replace a rescue inhaler.

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