• Trelegy Ellipta is a once-daily therapy that combines three medicines into one inhaler. It combines an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA).
• ICS medicines work by decreasing lung inflammation (swelling) that can cause breathing problems.
• LAMA and LABA medicines are anticholinergic drugs that help to relax the muscles around the airways in the lungs. This helps to lessen symptoms like wheezing, coughing, chest tightness or shortness of breath, all of which make it hard to breath.

• Trelegy Ellipta can be taken once a day as it is a long-acting medicine that contains three medicines in one inhaler.
• It is approved by the FDA for three uses: for the long-term maintenance of chronic obstructive pulmonary disease (COPD); for the daily maintenance treatment of airflow obstruction in patients with COPD; and for the maintenance treatment of asthma in adults.
• COPD is a long-term lung disease that includes chronic bronchitis, emphysema, or both. It can improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms).
• Because it contains three medicines, it may be useful for those on a fixed-dose combination of fluticasone / vilanterol (Breo Ellipta) who need added bronchodilation, or those who are already using Breo Ellipta and Incruse Ellipta (umeclidinium) as 2 separate medicines.
• Trelegy Ellipta is approved in two different strengths for asthma, both given once daily.
• 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.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• In COPD patients: Upper respiratory tract infection, a runny nose and sore throat, pneumonia, taste disturbances, bronchitis, constipation, thrush (yeast infection) in your mouth and throat, 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, and inflammation of the sinuses.
• In asthma patients: common cold symptoms (13% to 15%), rhinitis (runny or stuffy nose), painful and frequent urination (signs of a urinary tract infection), upper respiratory tract infection (3% to 6%), bronchitis (3% to 5%), flu, respiratory tract infection, headache (5% to 9%), inflammation of the sinuses, and back pain.
• Trelegy Ellipta is NOT a fast-acting rescue medicine to be used during a sudden breathing attack in COPD or asthma. It does not work fast enough to treat a bronchospasm attack. Seek emergency treatment or call 911 if your breathing problems get worse quickly.
• It is not known if this medicine is safe and effective in children younger than 18 years of age.
• If you have glaucoma, Trelegy Ellipta may worsen your disease. Tell your doctor if you have glaucoma or elevated eye pressure before you start treatment.
• It is not known if the medicines in Trelegy Ellipta will harm your unborn baby or pass into your breast milk and harm your baby. Tell your doctor if you are pregnant, planning a pregnancy, breastfeeding or planning to breastfeed before you start treatment.
• Do not use Trelegy Ellipta if you have a severe allergy to milk proteins (like lactose). Ask your healthcare provider if you are not sure if this applies to you.

This is not a complete list of side effects, precautions or warnings, and others may occur. Call your doctor for medical advice about side effects, precautions or warnings.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Do not use Trelegy Ellipta to treat sudden, severe symptoms of COPD or asthma. If you need a fast-acting inhaler like albuterol, contact your health care provider right away, as you should always have one on hand.
• Do not use this medicine if you are allergic to any active ingredients (fluticasone furoate, umeclidinium, vilanterol) or inactive ingredients (lactose monohydrate [contains milk proteins], magnesium stearate). Ingredients may change. You can find an updated list of ingredients at the end of the manufacturer’s patient information.
• Before you start treatment, tell your doctor if you have: heart or liver problems, high blood pressure, diabetes, seizures or epilepsy, thyroid problems, osteoporosis (weak or brittle bones), an immune system problem, or glaucoma (including increased pressure in your eye, cataracts, blurred vision, or other changes in vision).
• If you have been using an oral steroid (corticosteroid) medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.
• You can take Trelegy Ellipta in the morning or the evening, but do not take more than one inhalation per day. You should use Trelegy Ellipta at the same time each day. This will help to keep you free of symptoms for about 24 hours.
• If you miss a dose of Trelegy Ellipta, take it as soon as you remember, and then take your next dose at your usual time. Do NOT take two doses at the same time.
• Rinse your mouth with water without swallowing after use to help prevent thrush (a yeast infection in your mouth and throat area).
• Store Trelegy Ellipta at room temperature between 68°F and 77°F (20°C and 25°C). Keep the inhaler dry and away from heat and sunlight. Only remove the inhaler from the unopened tray when ready to use.
• To keep track of how long you have been using this medicine, write the date of when you open the tray on inhaler label. Trelegy Ellipta should be discarded in the trash 6 weeks after first use OR when the counter reads “0” (which means you are out of medicine), whichever occurs first.
• Keep all medicines out of the reach of children and pets.

The FDA-approved strength for treatment of both COPD and asthma in adults is fluticasone furoate 100 mcg / umeclidinium 62.5 mcg / vilanterol 25mcg. There is an additional strength for asthma only (not for COPD) which is fluticasone furoate 200 mcg / umeclidinium 62.5 mcg / vilanterol 25mcg.

COPD:

• In September 2017, the FDA approved Trelegy Ellipta for the long-term maintenance of chronic obstructive pulmonary disease (COPD). In 2018, this use was expanded to include the daily maintenance treatment of airflow obstruction in patients with COPD.
• A one-year long clinical study with over 10,000 patients showed that Trelegy was more effective for reducing moderate-to-severe flare-ups (exacerbations) and improving lung function compared to using Breo 100 (an ICS/LABA) or Anora (a LAMA/LABA). Results showed a 25% reduction in the annual rate of flare-ups vs. Anoro, and a 15% reduction in the annual rate of flare-ups vs. Breo.
• Lung function improvements (change from baseline in trough forced expiratory volume over one second [FEV1] at month 12) were also significant in the study. With Trelegy Ellipta, there was a 97 mL improvement vs Breo and 54 mL improvement vs Anoro. Trelegy was also shown to reduce the annual rate of hospitalizations due to severe flare-ups (34% reduction vs. Anoro and 13% reduction vs. Breo).
• Patients taking Trelegy also reported a significant improvement in their health-related quality of life based on an FDA-recognized questionnaire that measures activities, impact on daily life, and symptoms.

Asthma:

• In 2020, the FDA approved a third indication for Trelegy Ellipta for maintenance treatment of asthma in adults.
• Clinical studies with over 2,400 patients evaluated improvement in lung function as measured by the change from baseline in trough forced expiratory volume over one second (FEV1) at 24 weeks of treatment.
• Compared to Breo (fluticasone furoate 100 mcg / vilanterol 25 mcg), Trelegy Ellipta 100/62.5/25 mcg once daily showed a 110 mL significant improvement in FEV1 at 24 weeks.
• When the higher dose Trelegy Ellipta 200/62.5/25 mcg once daily was compared to Breo 200/25 mcg dual therapy, a significant improvement of 92 mL in trough FEV1 was seen for Trelegy.

Medicines that interact with Trelegy Ellipta may either decrease its effect, increase its side effects, or change how other medicines work. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor or pharmacist about how drug interactions should be managed.

Trelegy Ellipta interacts with about 500 medications, and most of these interactions are moderate in severity, but may still have an important clinical impact. Common medications that may interact with Trelegy Ellipta include:

• Strong cytochrome P450 3A4 inhibitors, like ketoconazole, an antifungal medicine
• Monoamine oxidase inhibitors, a class of antidepressants
• Tricyclic antidepressants
• Beta-blockers, a heart medicine class
• Diuretics, often called “water pills”
• Anticholinergics, for example, cold or allergy medicines (Benadryl and others)

Always tell your doctor and pharmacist about all the medicines you take, including prescription medicines, over-the-counter drugs, vitamins, and herbal dietary supplements. They can review any possible drug interactions for you. Tell them each time you start a new medication.

Note: This list is not all-inclusive and includes only common medications that may interact with Trelegy Ellipta. Refer to the prescribing information for Trelegy Ellipta for a complete list of interactions.