Trelegy Ellipta

Chronic Obstructive Pulmonary Disease (COPD)

Trelegy Ellipta is used for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD. This includes chronic bronchitis and emphysema. In addition to improving lung function, it is used to reduce the frequency of COPD exacerbations, which are periods where symptoms suddenly worsen.

Asthma

This medication is approved for the maintenance treatment of asthma in adults 18 years of age and older. It is typically prescribed for patients who continue to experience symptoms despite using other long-term asthma control medications.

Important Limitations of Use

It is important to understand how this medication fits into a treatment plan:

• Not a rescue inhaler: Trelegy Ellipta will not replace a rescue inhaler for sudden breathing problems. It does not work fast enough to treat an acute asthma attack or a sudden COPD flare-up.
• Maintenance only: This drug must be used every day to be effective, even if you are not currently experiencing symptoms.
• Age restrictions: This medication is not approved for use in children or adolescents under the age of 18.

Healthcare providers prescribe this medication to provide three different types of medicine in a single inhaler to help keep airways open and reduce inflammation over a 24-hour period.

Three-Way Action

Trelegy Ellipta contains three active ingredients that target different aspects of lung disease to improve breathing:

• Fluticasone furoate: This is an inhaled corticosteroid that works by reducing inflammation and swelling in the airways. By calming the immune response in the lungs, it helps prevent the airways from becoming overly sensitive and narrow.
• Umeclidinium: This is a long-acting muscarinic antagonist (LAMA), also known as an anticholinergic. It blocks the action of a chemical called acetylcholine, which normally causes the muscles around the airways to tighten. By blocking this chemical, the muscles stay relaxed.
• Vilanterol: This is a long-acting beta2-adrenergic agonist (LABA). It works by stimulating specific receptors in the lungs that trigger the airway muscles to relax and stay open.

Maintenance vs. Rescue

The ingredients in Trelegy Ellipta are long-acting, meaning they provide a steady effect over a 24-hour period. This medication is designed to be used once every day to prevent symptoms from occurring. Because it takes time for the medication to work, it will not stop a sudden attack of breathlessness or wheezing. A separate fast-acting rescue inhaler is required for the immediate relief of sudden symptoms.

Common Side Effects

Many people using Trelegy Ellipta experience mild side effects. These may include:

• Upper respiratory tract infections, such as the common cold or sinus infections
• Headache
• Back or joint pain
• Cough or sore throat
• Changes in taste
• Nausea, vomiting, or diarrhea
• Bronchitis

Serious Side Effects

While less common, some side effects require immediate medical attention. These include:

• Oral Thrush: A fungal infection in the mouth or throat. Rinsing your mouth with water without swallowing after each dose can help prevent this.
• Pneumonia: People with COPD may have a higher risk of developing pneumonia while using this medication. Symptoms include fever, chills, or increased mucus production.
• Heart Problems: Increased blood pressure, fast or irregular heartbeat, and chest pain.
• Vision Changes: New or worsening glaucoma or cataracts, which may cause eye pain or blurred vision.
• Bone Weakening: Long-term use of inhaled corticosteroids may lead to decreased bone mineral density (osteoporosis).
• Paradoxical Bronchospasm: Sudden, unexpected breathing difficulty immediately after inhalation.
• Immune System Effects: Increased susceptibility to infections and a weakened response to viruses like chickenpox or measles.
• Hormonal Changes: Adrenal insufficiency, which can cause tiredness, weakness, and low blood pressure.
• Metabolic Changes: High blood sugar levels (hyperglycemia) or low potassium levels (hypokalemia).

Acute Symptoms and Deterioration

Trelegy Ellipta should not be used to treat sudden or acute symptoms of asthma or COPD. A rescue inhaler is necessary for sudden breathing problems. If breathing problems worsen quickly or if the rescue inhaler does not provide relief, medical attention is required.

Infection Risks

Because this medication contains a corticosteroid, it can weaken the immune system and increase the risk of certain infections:

• Oral Candidiasis: Fungal infections (thrush) can develop in the mouth and throat. Rinsing the mouth with water without swallowing after use may help reduce this risk.
• Pneumonia: Patients with COPD have an increased risk of developing pneumonia when using inhaled corticosteroids.
• Existing Infections: This medication may worsen existing tuberculosis, fungal, bacterial, viral, or parasitic infections.

Cardiovascular and Nervous System Effects

The long-acting beta-agonist (LABA) component can cause significant cardiovascular effects in some people, including increased pulse rate, elevated blood pressure, and abnormal heart rhythms. Caution is advised for individuals with pre-existing heart conditions or high blood pressure.

Eye and Urinary Problems

Trelegy Ellipta may worsen certain conditions, including:

• Glaucoma and Cataracts: Increased eye pressure, glaucoma, and cataracts have been reported. Regular eye exams may be necessary.
• Urinary Retention: This medication can cause or worsen urinary retention, particularly in individuals with prostate problems or bladder-neck obstructions.

Other Serious Precautions

• Paradoxical Bronchospasm: In some cases, inhaled medicines can cause an immediate increase in wheezing after dosing. If this occurs, the medication should be stopped immediately.
• Bone Density: Long-term use of inhaled corticosteroids may lead to a decrease in bone mineral density.
• Adrenal Suppression: Switching from oral steroids to inhaled steroids can cause signs of adrenal insufficiency.
• Milk Protein Allergy: This product contains lactose and should not be used by individuals with a severe hypersensitivity to milk proteins.

Pregnancy

There are no adequate or well-controlled studies of Trelegy Ellipta in pregnant women. Because human data are limited, the risk of birth defects or miscarriage is not fully known. In animal studies, the individual components of this medication showed some adverse effects on fetal development, but these typically occurred at doses much higher than those used by humans.

If you are pregnant or planning to become pregnant, discuss the risks and benefits of continuing treatment with your doctor. It is important to keep asthma or COPD well-controlled during pregnancy, as poorly managed respiratory conditions can pose risks to both the parent and the fetus.

Labor and Delivery

Trelegy Ellipta contains vilanterol, a long-acting beta2-agonist. These types of medications may interfere with uterine contractions during labor. Use during labor and delivery should be limited to cases where the benefit clearly justifies the risk to the mother.

Breastfeeding

It is not known whether the components of Trelegy Ellipta pass into human breast milk, affect the breastfed child, or impact milk production. While some corticosteroids can be found in breast milk, the amount absorbed into the body after inhalation is typically very low. Consult with a healthcare provider to weigh the benefits of breastfeeding against any potential risks to the infant.

Dosage Forms

Trelegy Ellipta is provided as a dry powder for oral inhalation. The medication is contained within a plastic inhaler device that houses foil blister strips.

• Inhalation Powder: A dry powder formulation intended for oral inhalation using the provided inhaler.

The inhaler is a disposable device that delivers the medication when the user inhales through the mouthpiece. It is designed to be used without a spacer.

FDA Approval Status

Trelegy Ellipta is approved by the U.S. Food and Drug Administration (FDA) as a combination inhalation powder. It contains three active ingredients: fluticasone furoate (an inhaled corticosteroid), umeclidinium (an anticholinergic), and vilanterol (a long-acting beta2-adrenergic agonist).

Approved Indications

The medication is indicated for the following uses in patients 18 years of age and older:

• Chronic Obstructive Pulmonary Disease (COPD): It is used for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It is also approved to help reduce the frequency of COPD exacerbations.
• Asthma: It is used for the long-term, once-daily maintenance treatment of asthma.

Limitations of Use

Trelegy Ellipta is not approved for the relief of acute bronchospasm. It is not a rescue medication and should not be used to treat sudden breathing problems.

Regulatory Safety Information

There is currently no Boxed Warning or Risk Evaluation and Mitigation Strategy (REMS) required by the FDA for Trelegy Ellipta. While long-acting beta2-adrenergic agonists (LABA) were previously subject to specific safety warnings when used alone for asthma, the FDA has determined that these risks are significantly reduced when a LABA is used in a fixed-dose combination with an inhaled corticosteroid.

Generic Status

Trelegy Ellipta is currently available only as a brand-name medication. There are no FDA-approved generic versions of the fluticasone, umeclidinium, and vilanterol combination inhaler at this time. Generic versions typically become available only after the brand-name manufacturer's patents expire.

Insurance and Coverage

The amount you pay for Trelegy Ellipta often depends on your insurance plan. Most Medicare Part D and private insurance plans provide coverage, though the medication may be placed on a specific tier in the plan's formulary, which determines the copay or coinsurance amount.

Financial Assistance

For individuals without insurance or those with high out-of-pocket costs, there may be options to reduce the price:

• Manufacturer Savings: The manufacturer may offer savings cards or coupons for patients with commercial insurance.
• Patient Assistance Programs: Programs may be available for eligible patients who meet specific income requirements or are uninsured.
• Pharmacy Discounts: Some retail pharmacies offer discount programs that may lower the cash price of the medication.

Patients are encouraged to contact their insurance provider or pharmacist to determine the exact out-of-pocket cost based on their specific coverage.