Trelegy Ellipta

The active ingredients in the Trelegy Ellipta inhaler are fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate. This triple therapy is indicated for the long-term treatment of asthma and chronic obstructive pulmonary disease (COPD).

Fluticasone furoate is an inhaled corticosteroid (ICS) that works by reducing swelling in the lining of your lungs. Umeclidinium bromide is an anticholinergic (long-acting muscarinic antagonist or LAMA) which reduces smooth muscle contractions, helps to relax the muscles in your lungs, and causes bronchodilation. Finally, vilanterol trifenatate is a long-acting beta agonist (LABA) which also acts on the smooth muscles in your lungs to help them relax and open up your airways (bronchodilation).

This medication is intended for maintenance treatment for asthma or COPD patients over the age of 18, not as a rescue inhaler like albuterol for acute bronchospasm.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Trelegy Ellipta. However, the following is a synopsis of the general guidelines for the use of Trelegy Ellipta:

Important information:

• If you open and close the cover without inhaling the medication, the dose will be lost and no longer available to be inhaled.

Instructions for use:

1. Peel back the lid to open the tray, and dispose of the desiccant and tray.

2. Write the date you opened the tray on the inhaler, and ensure you don’t use it past 6 weeks after this date.

3. The counter on the inhaler should show 30.

4. Open the inhaler by sliding down the cover to reveal the mouthpiece. The reader should now show 29. If it does not, call your physician or pharmacist, as the inhaler will not deliver the medicine.

5. Breathe out away from the inhaler, then place the mouthpiece between your lips and form a seal. Ensure your fingers are not covering the vent.

6. Take a long, deep breath in through your mouth, then remove the inhaler and hold your breath for 3-4 seconds, or as long as possible.

7. Breathe out slowly and gently, and do not take another dose even if you don’t taste or feel the medication (this is normal).

8. Before closing the cover, you may wipe the mouthpiece with a dry tissue, but this is not required. Do not wash the inhaler in water.

9. Always rinse your mouth with water after using this inhaler, and spit out the water (do not swallow).

10. Keep an eye on the dose counter. Once you have nine doses left, you should see a red area on the counter, and it is time to get a refill.

11. Dispose of the inhaler in the garbage, out of reach of children and pets.

The most common side effects of Trelegy Ellipta include:

• Pneumonia (more common in COPD patients), upper respiratory tract infection, and bronchitis.
• Taste disturbances.
• Constipation.
• Oral thrush.
• Nausea and vomiting
• Diarrhea.
• Joint pain.
• Cough and hoarseness.
• Runny nose and sore throat.
• Painful/ frequent urination, urinary tract infection.
• Headache
• Back pain.

Some individuals may experience serious side effects while using Trelegy Ellipta. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Fungal infections of the mouth/ throat (thrush or candidiasis), which may present as white patches on the roof of your mouth - to avoid/ reduce this risk, always rinse your mouth after using this inhaler, and spit out the water (don’t swallow).

• Pneumonia, which may present with symptoms of cough, fever, chills, and increased breathing problems. This is more common in people with COPD who take this medication.

• Adrenal gland insufficiency, which may present with symptoms of fatigue, weakness, nausea, vomiting, and low blood pressure.

• Serious allergic reactions, which may present as rash, hives, swelling of the face, mouth, or tongue, and/ or trouble breathing.

• Effects on the heart (increased blood pressure, irregular heartbeat, heart rate or heart rhythm, chest pain) or the nervous system (tremor or nervousness).

• Thinning or weakness of the bones (osteoporosis).

• Eye problems such as glaucoma or cataracts - to manage this risk, you should have regular eye exams while using this medication. Symptoms may include eye pain/ discomfort, blurred vision, or red eyes.

• Urinary retention, which may present as difficulty urinating, urinating more frequently, or painful urination.

• Growth reduction in children and adolescents.

These are not all of the possible side effects of Trelegy Ellipta. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Trelegy Ellipta, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Cardiovascular disorders, such as high blood pressure.
• Low bone mineral density, such as osteoporosis.
• Eye problems, such as narrow-angle glaucoma or cataracts.
• Prostate or bladder problems, such as prostatic hyperplasia (BPH) or bladder-neck obstruction.
• Convulsive disorders.
• Thyrotoxicosis, type 2 diabetes, or ketoacidosis.
• Immune system problems, including viral, bacterial, and fungal infections.
• Liver dysfunction.
• Exposure to chickenpox or measles.

A severe hypersensitivity to milk proteins (lactose) or any ingredients in the Trelegy Ellipta inhaler.

Sudden, severe COPD or asthma attack.

When taken daily, Trelegy Ellipta can take several weeks before showing a marked effect on your symptoms.

When Trelegy Ellipta is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• CYP450 inhibitors such as ketoconazole should be used with caution due to an increased risk of corticosteroid and heart effects.

• Antidepressants such as amitriptyline, doxepin, and phenelzine should be used with caution due to the increased risk of heart problems.

• Beta-blockers should be used with caution due to the risk of severe bronchospasm.

• Diuretics, when combined with Trelegy Ellipta, can worsen/ cause severe cardiovascular effects, or a reduction in your potassium levels (hypokalemia).

• Anticholinergics, such as diphenhydramine (found in many allergy or cough/ cold products such as Benadryl) which can increase the anticholinergic effects of Trelegy Ellipta (dry mouth or eyes, blurred vision, fast heart rate, urinary retention).

Fluticasone furoate/ umeclidinium/ vilanterol: 100/62.5/25 mcg used for asthma and COPD.

Fluticasone furoate/ umeclidinium/ vilanterol: 200/62.5/25 mcg used for asthma only.

This inhaler should be stored at room temperature in a dry place away from heat and sunlight. Keep out of reach of children.

Trelegy Ellipta is manufactured by GlaxoSmithKline (GSK).

No, there is no generic version of Trelegy Ellipta, but similar triple therapy combinations are available from AstraZeneca -Breztri (budesonide/glycopyrrolate/formoterol).

If you find this medication is not improving your COPD or asthma symptoms after a 2-4 week trial, let your doctor know, and they can recommend the best options going forward.

Overall, as this drug is inhaled, it is expected that it does not reach high enough concentrations in the blood to cause harm to a growing fetus. However, talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

For all components, there is no human data on the exposure to a nursing infant, but the properties of the drugs suggest they pose minimal risk. However, talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.