Fluticasone/Vilanterol, Inhalation

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KEY POINTS

• This medicine is inhaled through the mouth to help control symptoms and prevent wheezing in people with asthma or COPD. It does not stop asthma attacks that have already started. 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; long-acting beta-agonist; bronchodilator

Generic and brand names: fluticasone/vilanterol, inhalation; Breo Ellipta

What is this medicine used for?

This medicine is inhaled through the mouth. It helps control symptoms and prevent wheezing in people with asthma or COPD. It does not stop asthma attacks that have already started.

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 cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• Eye problems such as cataracts or glaucoma
• Heart disease or irregular heartbeat
• High blood pressure
• Liver disease
• Osteoporosis
• Problems with potassium levels in the blood
• Seizures
• Thyroid disorder

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: Tell 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?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

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.

Use this medicine exactly as your healthcare provider prescribes. Do not use more or less than prescribed. Use it every day at the same time. You may feel better in a day or two after you start using this medicine, but you will probably need to use the medicine for 2 weeks to feel its full benefit. Do not stop taking this medicine without your healthcare provider's approval. Suddenly stopping this medicine may make your symptoms worse.

Check with your healthcare provider before using this medicine in children under age 18.

If your healthcare provider prescribes another medicine to be inhaled, ask how long you should wait between doses of the different medicines.

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).

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use two doses on the same day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: chest pain, fast or irregular heartbeat, seizures, tremors, nervousness, muscle cramps or weakness, headache, dry mouth, nausea, vomiting, dizziness, fainting.

What should I watch out for?

This medicine must not be the only medicine you use to treat COPD. 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. Talk with your healthcare provider if you have any questions.

In people with asthma, long-acting beta2-adrenergic agonists increase the risk of asthma-related hospitalization or death. Talk with your healthcare provider about this. If you have any of these symptoms, call your healthcare provider right away:

• You need to use more puffs than usual of your short-acting inhaler or use it more often.
• You have severe breathing trouble that does not improve, such as persistent wheezing, coughing, or shortness of breath.
• You have a bluish color in your lips or fingernails or cannot speak.
• You have any breathing symptoms that are getting worse.

If you have switched from steroid tablets taken by mouth to this medicine, you may need extra doses of steroid tablets during periods of stress such as injury, surgery, infection, or severe asthma attacks. Talk with your healthcare provider about this.

Treatment with this medicine may affect bone density. Your healthcare provider may order tests to determine if this medicine is affecting your bones.

Rarely, this medicine may cause vision problems. You need to have regular eye exams while taking this medicine.

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

If you use this medicine for a long time, you will need to have checkups regularly to see how this medicine affects you. Keep all appointments.

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

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.): Increased trouble breathing or coughing, increased sputum or change in sputum color, chest pain, fast or irregular heartbeat, unexplained bruising or sores, unusual tiredness or weakness, severe dizziness or fainting, fever, sore throat, joint or muscle pain, painful red or white patches in your mouth, changes in vision, severe nervousness, tremors, seizures.

Other: Headache, runny or stuffy nose, nausea, vomiting, dry mouth, dizziness, hoarseness, diarrhea, shakiness, trouble sleeping.

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:

• Aldesleukin (Proleukin)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), linezolid (Zyvox), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, trazodone, and sertraline (Zoloft)
• Antifungal medicines such as amphotericin b (Abelcet, AmBisome, Amphotec), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Artemether/lumefantrine (Coartem)
• Atomoxetine (Strattera)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), dasatinib (Sprycel), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), procarbazine (Matulane), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as acarbose (Precose), glipizide (Glucotrol), glyburide (Glynase), metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), chlorthalidone, ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), hydroflumethiazide (Saluron), and torsemide (Demadex)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Ephedrine, epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen), phenylephrine (Neo-Synephrine, Sudafed PE), or pseudoephedrine (Sudafed)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), flecainide, nicardipine (Cardene), propafenone (Rythmol), procainamide, quinidine, 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), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Natalizumab (Tysabri)
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), and ondansetron (Zofran)
• Other medicines to treat breathing or lung problems such as arformoterol (Brovana), budesonide/formoterol (Symbicort), formoterol (Perforomist), indacaterol (Arcapta), mometasone/formoterol (Dulera), olodaterol (Striverdi Respimat), and salmeterol (Serevent)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Rasagiline (Azilect)
• Tetrabenazine (Xenazine)
• Tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), and nortriptyline (Pamelor) (Do not take this medicine and a tricyclic antidepressant within 14 days of each other.)

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. Tell all healthcare providers who treat you about any other medicines you are taking by mouth, inhalation, or shots.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light. Do not open the cover of the inhaler until you are ready to use it. If you open and close the cover without inhaling the medicine, you will lose the dose.

Write the date you open the foil tray on the label on the inhaler. Discard the medicine 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.