Arnuity Ellipta (fluticasone) is a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Arnuity Ellipta is used to prevent asthma attacks. This medicine will not treat an asthma attack that has already begun.

Arnuity Ellipta is sometimes used together with steroid medicine taken by mouth.

Arnuity Ellipta is for use in adults and children who are at least 5 years old.

Arnuity Ellipta is not a rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

You should not use the inhalation powder if you are allergic to milk proteins.

Before taking this medicine

You should not use Arnuity Ellipta if you are allergic to fluticasone or to milk proteins.

Do not use Arnuity Ellipta to treat an asthma attack that has already begun.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• any type of infection (bacterial, viral, or fungal);

• glaucoma or cataracts;

• an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);

• tuberculosis;

• herpes infection of the eyes;

• liver disease;

• low bone mineral density; or

• a weak immune system.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether fluticasone will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using fluticasone inhalation. Ask your doctor about any risk.

Arnuity Ellipta is not approved for anyone younger than 5 years old.

Use Arnuity Ellipta exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Arnuity Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or stop using Arnuity Ellipta without your doctor's advice.

Arnuity Ellipta is a powder form of fluticasone that come with a special inhaler device preloaded with blister packs containing measured doses of fluticasone. The device opens and loads a blister of fluticasone each time you use the inhaler. The disk device is not to be used with a spacer. Follow the patient instructions provided with your medicine.

To prevent a yeast infection, rinse your mouth with water (do not swallow) after using this medicine. Pay close attention to your dental hygiene. Fluticasone can cause cavities or tooth discoloration.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

You should not stop using Arnuity Ellipta suddenly or your asthma could get worse.

If you stop taking any steroid medicine, you may need to stop gradually. Follow your doctor's instructions.

If you switched to Arnuity Ellipta from an oral (taken by mouth) steroid, you should not stop using the steroid suddenly. Follow your doctor's instructions about tapering your dose. You may need to restart the oral steroid medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

Seek medical attention if you think any of your asthma medications are not working as well as usual.

Your doctor will need to check your progress while you are using Arnuity Ellipta. Your vision may also need to be checked at regular intervals.

Call your doctor if your symptoms do not improve after 2 weeks of treatment, or if symptoms get worse. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

Store at room temperature away from moisture, light, and extreme heat or cold.

Store Arnuity Ellipta in the unopened foil tray until ready to use. Throw away any unused medicine 6 weeks after you open the foil tray or when the counter on your inhaler device shows "0", whichever comes first.

You should not use Arnuity Ellipta if you are allergic to fluticasone or to milk proteins.

Do not use Arnuity Ellipta to treat an asthma attack that has already begun.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• any type of infection (bacterial, viral, or fungal);

• glaucoma or cataracts;

• an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);

• tuberculosis;

• herpes infection of the eyes;

• liver disease;

• low bone mineral density; or

• a weak immune system.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether fluticasone will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using fluticasone inhalation. Ask your doctor about any risk.

Arnuity Ellipta is not approved for anyone younger than 5 years old.

Skip the missed dose and use the next dose of Arnuity Ellipta at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Do not use more than 1 inhalation per day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of fluticasone is not expected to produce life threatening symptoms. Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Get emergency medical help if you have signs of an allergic reaction to Arnuity Ellipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• weakness, tired feeling, nausea, vomiting, feeling like you might pass out;

• wheezing, choking, or other breathing problems after using this medicine;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• worsening of your asthma symptoms;

• blood vessel inflammation - fever, cough, stomach pain, weight loss, skin rash, severe tingling, numbness, chest pain; or

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Fluticasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Arnuity Ellipta side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat, sinus pain;

• low fever, cough, wheezing, chest tightness;

• hoarseness or deepened voice;

• white patches or sores inside your mouth or on your lips;

• headache; or

• nausea, vomiting, upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antibiotic;

• antifungal medicine;

• antiviral medicine to treat HIV or AIDS; or

• steroid medicine.

This list is not complete. Other drugs may interact with fluticasone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.