WARNINGS
Do not use TRELEGY ELLIPTA:
• to treat sudden, severe symptoms of COPD or asthma.
• if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
• if you are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the ingredients in TRELEGY ELLIPTA. See the section ADDITIONAL INFORMATION below, about the ingredients in TRELEGY ELLIPTA.
USES
o TRELEGY ELLIPTA combines 3 medicines in 1 inhaler, an inhaled corticosteroid (ICS) medicine (fluticasone furoate), an anticholinergic medicine (umeclidinium), and a long-acting beta2-adrenergic agonist (LABA) medicine (vilanterol).
o ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
o Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
o TRELEGY ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
o TRELEGY ELLIPTA is a prescription medicine used long term (chronic) to treat people with:
Chronic Obstructive Pulmonary Disease (COPD):
o TRELEGY ELLIPTA is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
o TRELEGY ELLIPTA is used to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Asthma:
o TRELEGY ELLIPTA is a prescription medicine used to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing.
o 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 should not be used in children younger than 18 years of age.
It is not known if TRELEGY ELLIPTA is safe and effective in children younger than 18 years of age.
HOW TO USE
How should I use TRELEGY ELLIPTA?
Read the step-by-step instructions for using TRELEGY ELLIPTA at the end of this 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.
• TRELEGY ELLIPTA comes in 2 different strengths. Your healthcare provider prescribed the strength that is best for you.
• 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
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:
o increase in mucus (sputum) production o chills
o change in mucus color o increased cough
o fever o 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 or asthma symptoms, adrenal insufficiency can get worse and may cause death.
Symptoms of adrenal insufficiency include:
o feeling tired o nausea and vomiting
o lack of energy o low blood pressure (hypotension)
o weakness
• sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using 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:
o rash o swelling of your face, mouth, and tongue
o hives o breathing problems
• effects on heart.
o increased blood pressure o chest pain
o a fast or irregular heartbeat, awareness of heartbeat
• effects on nervous system.
o tremor o nervousness
• bone thinning or weakness (osteoporosis).
• eye problems including glaucoma, increased pressure in your eye, cataracts, blurred vision, worsening of narrow-angle glaucoma, or other changes in vision. 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:
o eye pain or discomfort o seeing halos or bright colors around lights
o nausea or vomiting o red eyes
o blurred vision
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:
o difficulty urinating o urinating frequently
o painful urination o 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).
• slowed growth in children.
Common side effects of TRELEGY ELLIPTA include:
COPD:
• upper respiratory tract infection • runny nose and sore throat
• pneumonia • taste disturbance
• bronchitis • constipation
• thrush in your mouth and throat. Rinse your mouth with water without swallowing after use to help prevent this.
• painful and frequent urination (signs of a urinary tract infection)
• headache • nausea, vomiting, and diarrhea
• back pain • mouth and throat pain
• joint pain • cough
• flu
• hoarseness
• inflammation of the sinuses
Asthma:
• runny nose and sore throat • painful and frequent urination (signs
• upper respiratory tract infection of a urinary tract infection)
• bronchitis • flu
• respiratory tract infection • headache
• inflammation of the sinuses • back pain
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.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TRELEGY ELLIPTA for a condition for which it was not prescribed. Do not give TRELEGY ELLIPTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TRELEGY ELLIPTA that is written for health professionals.
What are the ingredients in TRELEGY ELLIPTA?
Active ingredients: fluticasone furoate, umeclidinium, vilanterol
Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate
OVERDOSE
• 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.
MISSED DOSE
• 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.
STORAGE
• Store TRELEGY ELLIPTA at room temperature between 68-degrees F and 77-degrees F (20-degrees C and 25-degrees C). Keep in a dry place away from heat and sunlight.
• Store TRELEGY ELLIPTA in the unopened tray and only open when ready for use.
• Safely throw away TRELEGY ELLIPTA in the trash 6 weeks after you open the tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler. Keep TRELEGY ELLIPTA and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 12/2022
Prescribing Information: revision date 06/2023
Inhibitors of Cytochrome P450 3A4
Fluticasone furoate and vilanterol are substrates of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol. Caution should be exercised when considering the coadministration of TRELEGY ELLIPTA with ketoconazole and other known strong CYP3A4.
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and QTc Prolonging
Vilanterol, like other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.
Beta-adrenergic Receptor Blocking Agents
Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, but may also produce severe bronchospasm in patients with COPD or asthma. Therefore, patients with COPD or asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.
Non–Potassium-Sparing Diuretics
The electrocardiographic changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics.
Anticholinergics
There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of TRELEGY ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
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, increased pressure in your eye, cataracts, blurred vision, or other changes in vision. 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 or plan to breastfeed. It is not known if the medicines in TRELEGY ELLIPTA pass into your breast 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
