Fluticasone Furoate, Inhalation

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KEY POINTS

• This medicine is inhaled through the mouth to prevent asthma attacks. Use it exactly as directed.
• Do not use this medicine for sudden breathing problems. Your healthcare provider can prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: corticosteroid

Generic and brand names: fluticasone furoate, inhalation; Arnuity Ellipta

What is this medicine used for?

This medicine is a steroid that is inhaled through the mouth as long-term treatment to prevent asthma attacks. You may be able to reduce the dose of other steroids that you take in pill form to treat asthma.

This medicine will not stop asthma attacks that have already started. Your healthcare provider will prescribe another medicine to be used during an attack.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to milk proteins
• A weakened immune system from diseases such as HIV/AIDS or from cancer chemotherapy, or radiation therapy
• Diabetes
• Glaucoma or cataracts
• Liver disease
• Osteoporosis or brittle bones

Tell your provider if you currently have any kind of infection or fever, especially tuberculosis or herpes. Also tell your provider if you are taking any other corticosteroid medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 12. An adult should supervise the use of this medicine by a child.

This medicine must be inhaled regularly to be effective, once a day. This medicine is made in 2 different strengths. Your healthcare provider will determine which strength is best for you. Do not stop using this medicine without your healthcare provider’s approval.

After each use, rinse your mouth with water and spit the water out. This helps prevent thrush (a fungal infection that shows up as white spots on your tongue and in your mouth).

Do not increase or decrease the dosage on your own. Use this medicine exactly as your healthcare provider prescribes. Continue to take any other medicines that your healthcare provider has prescribed for you. If you are using other inhaled medicines, ask your healthcare provider or pharmacist which you should use first and how long you should wait between doses of the different medicines.

What if I miss a dose?

Use the medicine on the schedule your healthcare provider prescribes for you. If you miss a dose, 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 double doses. If you are not sure about what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

This medicine may cause an increase in wheezing or trouble breathing right after you use it. You should always have a fast-acting inhaled medicine with you to treat sudden wheezing.

Do not use this medicine for sudden breathing problems. Your healthcare provider may also prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem. Use all medicines as directed by your healthcare provider.

Contact your healthcare provider if your symptoms do not improve in 2 weeks or if they get worse.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. If you are exposed to an infectious disease, or have signs of infection, contact your healthcare provider right away. Chickenpox or measles may be more serious than usual while you are using this medicine. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you use this medicine for a long time, your healthcare provider will want to see you regularly to see how this medicine is affecting you. Keep all appointments for checkups and eye exams.

If you have any injury, surgery, infection, severe asthma attacks, or periods of stress, you may need to take steroid medicines by mouth. This is more likely if you have switched from steroid tablets to this medicine. Talk with your healthcare provider about this.

This medicine may limit growth in children. Your child will need regular checkups while taking this medicine. Talk with your provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing or catching your breath; wheezing; unusual tiredness or weakness; severe nausea or vomiting; severe dizziness or fainting; vision changes; unexplained fever, sore throat, or cough.

Other: Headache, dizziness, throat irritation, dry mouth, hoarseness, runny or stuffy nose, mild cough, white patches in your mouth, diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and telithromycin (Ketek)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), crizotinib (Xalkori), idelalisib (Zydelig), and imatinib (Gleevec)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• Hepatitis C medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Mifepristone (Korlym, Mifeprex)
• Natalizumab (Tysabri)
• Nefazodone
• Other corticosteroids such as cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), and prednisone (Prednisone Intensol)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat and direct sunlight. Store in the unopened foil tray and only open when ready for use. Discard 6 weeks after you open the foil tray or when the counter reads “0”, whichever comes first.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.