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 5 years and older.
- Arnuity Ellipta helps to prevent and control symptoms of asthma.
- Arnuity Ellipta is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden breathing problems. 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 5 years.
Who should not use Arnuity Ellipta?
Do not use Arnuity Ellipta:
- to treat sudden symptoms of asthma.
- 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 the end of this Patient Information for a complete list of ingredients in Arnuity Ellipta.
What should I tell my healthcare provider before using Arnuity Ellipta?
Before using Arnuity Ellipta, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems.
- have weak bones (osteoporosis).
- have an immune system problem.
- have eye problems such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision.
- are allergic to milk proteins.
- have any type of viral, bacterial, fungal, or parasitic infection.
- are exposed to chickenpox or measles.
- are pregnant or plan 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 breast 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.
How should I use Arnuity Ellipta?
Read the step-by-step instructions that come with Arnuity Ellipta.
- 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 3 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.
- Children and 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 1 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 of asthma and you should not take extra doses of Arnuity Ellipta to relieve these 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.
- your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
What are the possible side effects of 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 ICS (such as Arnuity Ellipta). During this transition period, 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 (hypotension)
- sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Arnuity Ellipta 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:
- 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 Ellipta.
Common side effects of Arnuity Ellipta include:
- runny nose and sore throat
- breathing problems (bronchitis)
These are not all the possible side effects of Arnuity Ellipta.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Arnuity Ellipta
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Arnuity Ellipta for a condition for which it was not prescribed. Do not give Arnuity Ellipta to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about Arnuity Ellipta that is written for health professionals.
How should 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 tray and only open when ready for use.
- Safely throw away Arnuity Ellipta in the trash 6 weeks after you open the 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)
For more information about Arnuity Ellipta, call 1-888-825-5249 or visit our website at www.ARNUITY.com.