Fluticasone Furoate (floo-TIK-a-sone FURE-oh-ate), Vilanterol Trifenatate (vye-LAN-ter-ol trye-FEN-a-tate)

Treats asthma and chronic obstructive pulmonary disease (COPD). Reduces the number of COPD flare-ups (worsening of symptoms for several days). This medicine contains a steroid.

Brand Name(s):

Breo Ellipta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Use this medicine at the same time each day.
• This medicine is a powder that is used with its own inhaler device. Keep the medicine in the foil tray until you are ready to use the inhaler.
• Each time you open the cover of the inhaler and hear a click, the inhaler is ready to use. Do not close the cover again until you have taken your dose. You will lose the dose if you open and close the cover without inhaling the medicine.
• When you take a dose, inhale through your mouth. Do not breathe in through your nose.
• Hold your breath for as long as you can up to 3 to 4 seconds, then breathe out slowly.
• You can clean the mouthpiece, if needed, using a dry tissue.
• The left half of the counter on the inhaler will turn red when there are less than 10 doses left. Refill your prescription as soon as possible. Throw the inhaler when it reaches 0, or if it has been 6 months since you last opened the foil tray.
• When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water after rinsing.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not take more than 1 inhalation per day.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away this medicine 6 weeks after it was opened or when the counter reads 0.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with similar inhaled medicines, including arformoterol, budesonide/formoterol, formoterol, indacaterol, or salmeterol.
• Some medicines can affect how fluticasone/vilanterol works. Tell your doctor if you are using any of the following:
  • Clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole
  • Beta-blocker
  • Diuretic (water pill)
  • Tricyclic antidepressant or MAO inhibitor within the past 2 weeks

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, diabetes, any kind of infection (including tuberculosis or herpes infection of the eye), eye problems (including cataracts or glaucoma), heart or blood vessel disease, high blood pressure, heart rhythm problems, osteoporosis, seizures, thyroid problems, or a weak immune system. Tell your doctor if you have ever been exposed to chickenpox or measles.
• This medicine may cause the following problems:
  • Increased risk of asthma-related hospital stays, intubations, and death
  • Increased risk of infection, including fungus infection in the mouth (thrush)
  • Increased risk of pneumonia in people who have COPD
  • Adrenal gland problems
  • Increased risk of paradoxical bronchospasm (trouble breathing right after use) and asthma-related death
  • Heart rhythm problems
  • Low bone mineral density, which may lead to osteoporosis
  • Glaucoma or cataracts
  • Slowed growth in children
• Do not use this medicine to treat acute attacks. You should have another medicine to use for an acute asthma attack or COPD flare-up. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in skin color, dark freckles, easy bruising, muscle weakness, round or puffy face
• Chest tightness, trouble breathing
• Dry mouth, increased thirst, or muscle cramps
• Eye pain, vision loss, seeing halos around lights
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Tiredness, weakness, nausea, vomiting

If you notice these less serious side effects, talk with your doctor:

• Headache
• Sores or white patches in your mouth or throat, pain when eating or swallowing

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088