Brand Name(s):
  • Breo Ellipta®
IMPORTANT WARNING

In a large clinical study, more people who used an asthma medication similar to vilanterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients who did not use the medication. Use of vilanterol inhalation may increase the risk of serious asthma problems or death in people who have asthma. Fluticasone and vilanterol inhalation has not been approved by the Food and Drug Administration (FDA) for the treatment of asthma. There is not enough information to tell whether inhaling fluticasone and vilanterol increases the risk of death in people who have chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema).

Talk to your doctor about the risks of using this medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluticasone and vilanterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

The combination of fluticasone and vilanterol is used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Vilanterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

HOW should this medicine be used?

The combination of fluticasone and vilanterol comes as a powder to inhale by mouth using a special inhaler. It is usually inhaled once a day. Inhale fluticasone and vilanterol at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part that you do not understand. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use fluticasone and vilanterol inhalation during a sudden COPD attack. Your doctor will prescribe a short acting (rescue) inhaler to use during COPD attacks.

Fluticasone and vilanterol inhalation controls COPD but does not cure it. Continue to use fluticasone and vilanterol even if you feel well. Do not stop using fluticasone and vilanterol without talking to your doctor. If you stop using fluticasone and vilanterol inhalation, your symptoms may return.

Before you use fluticasone and vilanterol inhalation for the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches.

To use the inhaler, follow these steps:

  • If you will be using a new inhaler for the first time, remove it from the box and the foil wrapper. Fill in the "Tray opened" and "Discard" blanks on the inhaler label with the date that you opened the pouch and the date 6 weeks later when you must replace the inhaler.
  • When you are ready to inhale your dose, slide the cover down to expose the mouthpiece until it clicks. If you open and close the inhaler without using your dose, you will waste the medication.
  • The counter will count down by 1 each time you open the cover. If the counter does not count down, your inhaler will not provide the medicine. If your inhaler does not count down, call your pharmacist or doctor.
  • Hold the inhaler away from your mouth and breathe out as far as you comfortably can. Do not breathe out into the mouthpiece.
  • Put the mouthpiece between your lips, and close your lips firmly around it. Take a long, steady, deep breath in through your mouth. Do not breathe in through your nose. Be careful not block the air vent with your fingers.
  • Remove the inhaler from your mouth, and hold your breath for about 3 to 4 seconds or as long as you comfortably can. Breathe out slowly.
  • You may or may not taste or feel the medicine released by the inhaler. Even if you do not, do not inhale another dose. If you are not sure you are getting your dose of fluticasone and vilanterol, call your doctor or pharmacist.
  • You may clean the mouthpiece with a dry tissue, if needed. Slide the cover up over the mouthpiece as far as it will go to close the inhaler.
  • Rinse your mouth with water, but do not swallow.
Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using fluticasone and vilanterol,

  • tell your doctor and pharmacist if you are allergic to fluticasone (Flonase, Flovent), vilanterol, any other medications, milk protein, or any of the ingredients in fluticasone and vilanterol inhalation. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor if you use another LABA such as formoterol (Foradil, in Symbicort) or salmeterol (in Advair, Serevent). These medications should not be used with fluticasone and vilanterol inhalation. Your doctor will tell you which medication you should use and which medication you should stop using.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clarithromycin (Biaxin); conivaptan (Vaprisol); diuretics ('water pills'); HIV protease inhibitors such as indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); other medications for COPD; metronidazole (Flagyl); nefazodone (Serzone); telithromycin (Ketek); and troleandomycin (TAO) Also tell your doctor and pharmacist if you are taking the following medications or have stopped taking them during the past 2 weeks: antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate). Many other medications may also interact with fluticasone and vilanterol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become weak and fragile), and if you have or have ever had high blood pressure, irregular heartbeat, seizures, hyperthyroidism (condition in which there is too much thyroid hormone in the body), diabetes, tuberculosis (TB), glaucoma (an eye disease), cataracts (clouding of the lens of the eyes), any condition that affects your immune system, or heart or liver disease. Also tell your doctor if you have a herpes eye infection, pneumonia, or any other type of infection.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluticasone and vilanterol, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fluticasone and vilanterol.
  • tell your doctor if you have never had chickenpox or measles and have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to these infections or if you develop symptoms of these infections, call your doctor immediately. You may need to get a vaccine (shot) to protect you from these infections.
What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inhale the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use more than one dose in a day and do not inhale a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Fluticasone and vilanterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • nervousness
  • shaking of a part of your body that you cannot control
  • joint pain
  • runny nose, sore throat

Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately or get emergency medical treatment:

  • hives
  • rash
  • swelling of the face, throat, tongue
  • pounding fast, or irregular heartbeat
  • chest pain
  • coughing, wheezing, or chest tightness that begins after you inhale fluticasone and vilanterol.
  • blurred vision
  • white patches in the mouth or throat
  • fever, chills, or other signs of infection
  • cough, difficulty breathing, or change in the color of sputum (the mucus you may cough up)

Fluticasone and vilanterol may increase the risk that you will develop glaucoma, cataracts, or osteoporosis. You will probably need to have regular eye exams and bone tests during your treatment with fluticasone and vilanterol.

Fluticasone and vilanterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the foil tray it came in, tightly closed, and out of reach of children. Store it at room temperature and away from sunlight, excess heat and moisture (not in the bathroom). Throw away the inhaler 6 weeks after you remove it from the foil overwrap or after every blister has been used (when the dose indicator reads 0), whichever comes first. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • seizures
  • chest pain
  • shortness of breath
  • dizziness
  • fast, pounding, or irregular heartbeat
  • nervousness
  • headache
  • shaking of a part of your body that you cannot control
  • muscle cramps or weakness
  • dry mouth
  • nausea
  • excessive tiredness
  • difficulty falling asleep or staying asleep
What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2013.