RISKS & SIDE EFFECTS

Please review this safety information.

Below, you can learn about the risks and side effects of TRELEGY ELLIPTA. This, however, is not all the safety information and does not replace talking to your healthcare provider about your medical condition or treatment. Please see the complete Prescribing Information, including Patient Information, for TRELEGY ELLIPTA for more information, or ask your healthcare provider or pharmacist.

Things to know about TRELEGY ELLIPTA

  • TRELEGY ELLIPTA is not approved for the treatment of asthma. TRELEGY ELLIPTA contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. TRELEGY ELLIPTA contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
  • TRELEGY ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden breathing problems. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Do not use TRELEGY ELLIPTA if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the ingredients in TRELEGY ELLIPTA. See "What are the ingredients in TRELEGY ELLIPTA?" below for a complete list of ingredients.

Before using TRELEGY ELLIPTA, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems.
  • have high blood pressure.
  • have seizures.
  • have thyroid problems.
  • have diabetes.
  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts. TRELEGY ELLIPTA may make your glaucoma worse.
  • are allergic to milk proteins.
  • have prostate or bladder problems, or problems passing urine. TRELEGY ELLIPTA may make these problems worse.
  • have any type of viral, bacterial, parasitic, or fungal infection.
  • are exposed to chickenpox or measles.
  • are pregnant or plan to become pregnant. It is not known if TRELEGY ELLIPTA may harm your unborn baby.
  • are breastfeeding. It is not known if the medicines in TRELEGY ELLIPTA pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRELEGY ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects.

  • Especially tell your healthcare provider if you take:
    • anticholinergics (including tiotropium, ipratropium, aclidinium)
    • atropine
    • other LABA (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol)
    • antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use TRELEGY ELLIPTA?

Read the step-by-step instructions for using TRELEGY ELLIPTA in the Patient Information.

  • Do not use TRELEGY ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Use TRELEGY ELLIPTA exactly as your healthcare provider tells you to use it. Do not use TRELEGY ELLIPTA more often than prescribed.
  • Use 1 inhalation of TRELEGY ELLIPTA 1 time each day. Use TRELEGY ELLIPTA at the same time each day.
  • If you miss a dose of TRELEGY ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • If you take too much TRELEGY ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
  • Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
  • Do not stop using TRELEGY ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • TRELEGY ELLIPTA does not relieve sudden symptoms of COPD and you should not take extra doses of TRELEGY ELLIPTA to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.

What are the possible side effects of TRELEGY ELLIPTA?

TRELEGY ELLIPTA can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY ELLIPTA to help reduce your chance of getting thrush.
  • pneumonia. People with COPD have a higher chance of getting pneumonia. TRELEGY ELLIPTA may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
    • increase in mucus (sputum) production
    • change in mucus color
    • fever
    • chills
    • increased cough
    • increased breathing problems
  • weakened immune system and increased chance of getting infections (immunosuppression).
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as TRELEGY ELLIPTA). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.
  • Symptoms of adrenal insufficiency include:
    • feeling tired
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure
  • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking TRELEGY ELLIPTA and call your healthcare provider right away.
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of your face, mouth, and tongue
    • breathing problems
  • effects on heart.
    • increased blood pressure
    • a fast or irregular heartbeat, awareness of heartbeat
    • chest pain
  • effects on nervous system.
    • tremor
    • nervousness
  • bone thinning or weakness (osteoporosis).
  • new or worsening eye problems including glaucoma, narrow-angle glaucoma, and cataracts. You should have regular eye exams while using TRELEGY ELLIPTA. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
    • eye pain or discomfort
    • nausea or vomiting
    • blurred vision
    • seeing halos or bright colors around lights
    • red eyes
    If you have these symptoms, call your healthcare provider right away before taking another dose.
  • urinary retention. People who take TRELEGY ELLIPTA may develop new or worse urinary retention. Symptoms of urinary retention may include:
    • difficulty urinating
    • painful urination
    • urinating frequently
    • urination in a weak stream or drips

If you have these symptoms of urinary retention, stop taking TRELEGY ELLIPTA, and call your healthcare provider right away before taking another dose.

  • changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).

Common side effects of TRELEGY ELLIPTA include:

  • upper respiratory tract infection
  • pneumonia
  • bronchitis
  • thrush in your mouth and throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • headache
  • back pain
  • joint pain
  • flu
  • inflammation of the sinuses
  • runny nose and sore throat
  • taste disturbance
  • constipation
  • painful and frequent urination (signs of a urinary tract infection)
  • nausea, vomiting, and diarrhea
  • mouth and/or throat pain
  • cough
  • hoarseness

These are not all the possible side effects of TRELEGY ELLIPTA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in TRELEGY ELLIPTA?

Active ingredients: fluticasone furoate, umeclidinium, vilanterol
Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

Once-daily TRELEGY is a prescription medicine used long term to treat COPD, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. TRELEGY is not used to relieve sudden breathing problems and won't replace a rescue inhaler. TRELEGY is not for asthma.

Important Safety Information

  • TRELEGY is not for asthma. TRELEGY contains vilanterol. Long-acting beta2-adrenergic agonist (LABA) medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. TRELEGY contains an inhaled corticosteroid (ICS), an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

Important Safety Information

  • TRELEGY is not for asthma. TRELEGY contains vilanterol. Long-acting beta2-adrenergic agonist (LABA) medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. TRELEGY contains an inhaled corticosteroid (ICS), an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
  • Do not use TRELEGY to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use TRELEGY if you have a severe allergy to milk proteins or are allergic to any of the ingredients in TRELEGY. Ask your healthcare provider if you are not sure.
  • Do not use TRELEGY more often than prescribed.
  • Do not take TRELEGY with other medicines that contain a LABA or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take.
  • Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need your rescue inhaler more often than usual or it does not work as well to relieve your symptoms.
  • TRELEGY can cause serious side effects, including:
    • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY to help reduce your chance of getting thrush.
    • pneumonia. People with COPD have a higher chance of getting pneumonia. TRELEGY may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: change in amount or color of mucus; fever; chills; increased cough; increased breathing problems.
    • weakened immune system and increased chance of getting infections.
    • reduced adrenal function. This can happen when you stop taking oral corticosteroids and start taking inhaled corticosteroids.
    • sudden breathing problems immediately after inhaling TRELEGY. If this happens, stop taking TRELEGY and call your healthcare provider right away.
    • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms: rash; hives; swelling of your face, mouth, and tongue; breathing problems.
    • effects on heart: increased blood pressure; a fast or irregular heartbeat, awareness of heartbeat; chest pain.
    • effects on nervous system: tremor; nervousness.
    • bone thinning or weakness (osteoporosis).
    • new or worsened eye problems, including vision changes or eye pain. You should have regular eye exams while using TRELEGY. If you have symptoms including vision changes, eye pain, nausea, or vomiting, stop taking TRELEGY and call your healthcare provider right away.
    • new or worse urinary retention. Symptoms may include: difficult, painful, or frequent urination; urination in a weak stream or drips. If you have these symptoms, stop taking TRELEGY and call your healthcare provider right away.
    • changes in laboratory blood values, including high levels of blood sugar and low levels of potassium.
  • Common side effects of TRELEGY include: upper respiratory tract infection; pneumonia; bronchitis; thrush in your mouth and throat (rinse your mouth with water without swallowing after use to help prevent this); headache; back pain; joint pain; flu; inflammation of the sinuses; runny nose and sore throat; taste disturbance; constipation; painful and frequent urination (signs of a urinary tract infection); nausea, vomiting, and diarrhea; mouth and/or throat pain; cough; and hoarseness.

Please see the full Prescribing Information, including Patient Information, for TRELEGY.

You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.