APPROVED USE •ARNUITY ELLIPTA is a prescription inhaled corticosteroid (ICS) medicine taken as 1 inhalation, once daily, for the control and prevention of asthma in adults and children aged 5 years and older. •ARNUITY helps to prevent and control symptoms of asthma. •ARNUITY is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Always have a rescue inhaler, such as albuterol, with you to treat sudden breathing problems.
Important Safety Information •Do not use ARNUITY to treat sudden symptoms of asthma. •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 (hypotension) •sudden breathing problems immediately after inhaling ARNUITY. If this happens, stop taking ARNUITY 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: rash hives swelling of your face, mouth, and tongue breathing problems •bone thinning or weakness (osteoporosis). •slow growth in children and adolescents. A child’s or adolescent’s growth should be checked often. •eye problems, including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. 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