Fluticasone Furoate (floo-TIK-a-sone FURE-oh-ate), Umeclidinium (ue-mek-li-DIN-ee-um), Vilanterol (vye-LAN-ter-ol)

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

Brand Name(s):

Trelegy Ellipta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder

• Your doctor will tell you how much medicine to use. Do not use more than directed. 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 until you have taken your dose. You will lose the dose if you open and close the cover without inhaling the medicine.
• To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible.
• Put the mouthpiece between your lips, and close your lips firmly around it. Take one long, steady, deep breath in through your mouth. Do not breathe in through your nose. Do not block the air vent with your fingers.
• Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds, then breathe out slowly.
• When you have finished all your inhalations, rinse your mouth out with water. Do not swallow.
• You may clean the mouthpiece using a dry tissue, if needed, before closing the cover.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The left half of the counter will turn red when there are less than 10 doses left, to remind you to refill your prescription.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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, formoterol, indacaterol, or salmeterol.
• Some medicines can affect how fluticasone/umeclidinium/vilanterol works. Tell your doctor if you are using any of the following:
  • Conivaptan, nefazodone
  • Beta-blocker
  • Diuretic (water pill)
  • Medicine to treat HIV/AIDS (including atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat infection (including clarithromycin, itraconazole, ketoconazole, telithromycin, troleandomycin, voriconazole)
  • 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, heart disease, asthma, high blood pressure, heart rhythm problems, any infection (including tuberculosis, herpes infection of the eye), seizures, thyroid problems, diabetes, trouble urinating, an enlarged prostate, bladder blockage, a recent exposure to measles or chickenpox, or a history of cataracts, glaucoma, or osteoporosis.
• This medicine may cause the following problems:
  • Increased risk of asthma-related hospital stays, intubations, and death
  • Increased risk of infections, including pneumonia
  • Adrenal gland problems
  • Increased risk of paradoxical bronchospasm (trouble breathing right after use) and asthma-related death
  • Changes in heart rhythm
  • 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.
• 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
• Bone pain
• Changes in skin color, dark freckles, weakness, tiredness, nausea, vomiting, weight loss
• Chest tightness, trouble breathing
• Difficulty passing urine, painful urination
• Dry mouth, increased thirst, muscle cramps
• Eye pain or vision changes
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Sores or white patches inside the mouth

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