Trelegy Ellipta

Trelegy Ellipta is used to treat COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema, and is also used for asthma in adults as a maintenance treatment. Trelegy Ellipta is used daily to improve symptoms and prevent bronchospasm in adults with COPD, and for adults with asthma, it is used daily to prevent and control symptoms of asthma.

Trelegy Ellipta is an inhalation powder containing a combination of fluticasone, umeclidinium, and vilanterol.

Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Umeclidinium is an anticholinergic. Vilanterol is a long-acting bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.

Trelegy Ellipta is not for use in treating an asthma attack or bronchospasm attack.

Vilanterol, when used alone, may increase the risk of death in people with asthma. However, this risk is not increased when vilanterol is used in a combination product with fluticasone and umeclidinium.

Step 1. Open the trayTrelegy Ellipta comes in a tray. Peel back the lid to open the tray. The tray contains a desiccant to reduce moisture. Do not eat or inhale the desiccant. Throw it away in the household trash, out of reach of children and pets.

Step 2. Open the cover of the inhaler device.Slide the cover down to expose the mouthpiece. You should hear a “click.” The counter will count down by 1 number. You do not need to shake this kind of inhaler. Your inhaler is now ready to use.

Step 3. Breathe out.While holding the inhaler away from your mouth, breathe out (exhale) fully. Do not breathe out into the mouthpiece.

Step 4. Inhale your medicine.Put the mouthpiece between your lips, and close your lips firmly around it. Your lips should fit over the curved shape of the mouthpiece.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 (or as long as comfortable for you).

Step 5. Breathe out slowly and gently.You may not taste or feel the medicine, even when you are using the inhaler correctly.Do not take another dose from the inhaler even if you do not feel or taste the medicine.

Step 6. Close the inhaler.You can clean the mouthpiece if needed, using a dry tissue, before you close the cover. Routine cleaning is not required.Slide the cover up and over the mouthpiece as far as it will go.

Step 7. Rinse your mouth.Rinse your mouth with water after you have used the inhaler and spit the water out. Do not swallow the water.

Important Note: When should you get a refill?When you have fewer than 10 doses remaining in your inhaler, the left half of the counter shows red as a reminder to get a refill.After you have inhaled the last dose, the counter will show “0” and will be empty.

Discard Trelegy Ellipta 6 weeks after you have taken it out of the tray, or if the dose indicator shows a zero, whichever comes first.Throw the empty inhaler away in your household trash out of reach of children and pets.

General Trelegy Ellipta instructions

Use Trelegy Ellipta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Using this medicine improperly can cause death or serious side effects on the heart.

Use Trelegy Ellipta at the same time each day, and not more than once in a 24-hour period.

Read and follow all patient instructions provided with the inhaler device. Ask your doctor or pharmacist if you do not understand these instructions.

To prevent yeast infection in your mouth, rinse with water (but do not swallow) after using Trelegy Ellipta.

Trelegy Ellipta is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Your dose needs may change due to surgery, illness, stress, or worsened COPD. Do not change your dose or dosing schedule without your doctor's advice.

You may need frequent medical tests. Your vision and your bone mineral density may also need to be checked.

Throw the inhaler device away 6 weeks after you have taken it out of the tray, or if the dose indicator shows a zero, whichever comes first.

Trelegy Ellipta is not a rescue medicine for asthma or bronchospasm attacks. It will not work fast enough to treat a bronchospasm attack. Use only fast-acting inhalation medicine for an attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

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 this medication.

You should not use Trelegy Ellipta if you are allergic to fluticasone, umeclidinium, vilanterol, or milk proteins.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• a weak immune system;
• any type of bacterial, fungal, or viral infection or an infection caused by parasites;
• liver disease;
• glaucoma, cataracts, or other vision problems;
• diabetes (or ketoacidosis);
• osteoporosis;
• a thyroid disorder; or
• an enlarged prostate, bladder obstruction, or urination problems.

If you have been using an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

It is not known whether Trelegy Ellipta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using Trelegy Ellipta. Ask your doctor about any risks.

Trelegy Ellipta is not approved for use by anyone younger than 18 years old.

Common Trelegy Ellipta side effects may include:

• cold or flu symptoms such as runny or stuffy nose, sore throat, cough, chest tightness;
• a lung infection;
• nausea, vomiting, constipation, diarrhea;
• joint pain;
• mouth sores, hoarse voice;
• headache, back pain; or mouth pain, changes in your sense of taste.

Serious Trelegy Ellipta side effects

Get emergency medical help if you have signs of an allergic reaction to Trelegy Ellipta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• tremors, nervousness, chest pain, fast or pounding heartbeats;
• sores or white patches in your mouth and throat, pain when swallowing;
• wheezing, choking, or other breathing problems after using this medicine;
• painful or difficult urination;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• a lung infection - fever, chills, cough with mucus, feeling short of breath;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder - worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose of Trelegy Ellipta for Chronic Obstructive Pulmonary Disease - Maintenance

Maintenance:1 inhalation (100 mcg-62.5 mcg-25 mcg or 200 mcg-62.5 mcg-25 mcg) orally once a dayMaximum dose: 1 inhalation every 24 hoursComments:-More frequent administration or a greater number of inhalations than the recommended dose should not be used, as adverse effects are more likely to occur with higher doses.-Use with caution when transferring from systemically active corticosteroid therapy.-Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to this drug.Use:-Long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema-Reduce exacerbations of COPD in patients with a history of exacerbations.

Usual Adult Dose for Asthma - Maintenance

Maintenance: 1 inhalation (fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg or 200 mcg-62.5 mcg-25 mcg) orally once a dayMaximum dose: 1 inhalation (fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg) every 24 hoursComments:-When choosing a starting dose, consider disease severity, previous asthma therapy (including inhaled corticosteroid use), current symptom control, and risk of future exacerbations.-Patients with inadequate response to fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg may gain additional improvement with fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg.-Consider reevaluation and other therapies if the response to fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg is inadequate.-If asthma symptoms arise between doses, use an inhaled short-acting beta-2 agonist (e.g. albuterol) for immediate relief.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Do not use more than 1 inhalation in a single day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Do not use a second inhaled long-acting bronchodilator that contains vilanterol or a similar medicine, such as salmeterol, indacaterol, formoterol, or arformoterol, or other anticholinergic medicines.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a medicine that contains fluticasone (a steroid).

Tell your doctor about all your other medicines, especially:

• atropine;
• antifungal or antiviral medicine;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• other long-acting bronchodilator asthma medication.
• blood pressure or heart medications (including beta-blockers or diuretics).

This list is not complete. Other drugs may interact with fluticasone, umeclidinium, and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep in a dry place away from heat and sunlight.
• Store device 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.

Active ingredients: fluticasone furoate, umeclidinium, vilanterol.

Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate.

GlaxoSmithKline, Durham, NC 27701.