Generic Name: fluticasone furoate inhalation powder
Date of Approval: August 20, 2014
Treatment for: Asthma
FDA Approves Arnuity Ellipta
The United States Food and Drug Administration (FDA) has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid for maintenance treatment of asthma. It is not indicated for relief of acute symptoms of asthma, which should be treated with a rescue inhaler.
Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used in three other approved respiratory medicines: Anoro Ellipta, Breo Ellipta and Incruse Ellipta.
Arnuity Ellipta should not be used if you have a severe milk allergy.
Like other inhaled corticosteroids, patients may develop a yeast infection called Candida albicans in the mouth and throat during treatment.Patients should be monitored for glaucoma and cataracts.
Common side effects include upper respiratory tract infection, nasopharyngitis, headache, and bronchitis.
Read the Patient Information that comes with this medicine before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is Arnuity Ellipta?
- Arnuity Ellipta is an inhaled corticosteroid (ICS) medicine used for the control and prevention of asthma in adults and children aged 12 years and older.
- It helps to prevent and control symptoms of asthma.
- It 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 provid er to have one prescribed for you.
- It is not known if it is safe and effective in children younger than 12 years.
Who should not use Arnuity Ellipta?
Do not use Arnuity Ellipta:
- to treat sudden symptoms of asthma. It 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.
- are allergic to fluticasone furoate or any of the ingredients listed below.
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, 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 this medicine may harm your unborn baby.
- are breastfeeding. It is not known if the active ingredient 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. Interactions 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.
How should I use Arnuity Ellipta?
Read the step-by-step instructions included in the packaging.
- Do not use this medicine unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
- Arnuity Ellipta comes in two different strengths. Your healthcare provider prescribed the strength that is best for you.
- Use the inhaler exactly as your healthcare provider tells you to use it.
- Do not exceed the recommended dosage.
- Adolescents may need help to use the inhaler.
- Use one inhalation once a day at the same time each day.
- If you miss a dose, take it as soon as you remember. Do not take more than one inhalation each day. Take your next dose at your usual time. Do not take two doses at one time.
- Do not stop using this medicine 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 of asthma. 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 four or more inhalations of your rescue inhaler in 24 hours for two or more days in a row
- you use one 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.
Arnuity Ellipta side effects
Serious side effects can inclue:
- fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after each dose 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, 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
- 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:
- 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 during treatment.
Common side effects include:
- runny nose and sore throat
- breathing problems (bronchitis)
Tell your healthcare provider about any side effect that bothers you or that does not go away.
This is not a complete list of side effects. 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.
See also: Side effects (in more detail)
How do I store Arnuity Ellipta?
- Store 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 in the unopened foil tray and only open when ready for use.
- Safely throw away 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 all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition that you have. It may harm them.
This Patient Information leaflet summarizes the most important information. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information that was written for healthcare professionals.
Active ingredients: fluticasone furoate
Inactive ingredients: lactose monohydrate (contains milk proteins)