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What is Trelegy Ellipta and how does it work?
What is Trelegy Ellipta and how is it used?
- Trelegy Ellipta 100/62.5/25 mcg is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma in patients aged 18 years and older.
- Trelegy Ellipta is NOT indicated for the relief of acute bronchospasm.
- 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).
- ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
- 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.
What are the side effects of Trelegy Ellipta?
Trelegy Ellipta can cause serious side effects, including:
If you have these symptoms, call your healthcare provider right away before taking another dose.
If you have these symptoms of urinary retention, stop taking Trelegy Ellipta, and call your healthcare provider right away before taking another dose.
- 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:
- 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:
- sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking 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:
- effects on heart.
- effects on nervous system.
- 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
Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
- urinary retention. People who take Trelegy Ellipta may develop new or worse urinary retention. Symptoms of urinary retention may include:
- 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:
- upper respiratory tract infection
- thrush in your mouth and throat. Rinse your mouth with water without swallowing after use to help prevent this.
- back pain
- joint pain
- inflammation of the sinuses
- runny nose and sore throat
- taste disturbance
- painful and frequent urination (signs of a urinary tract infection)
- nausea, vomiting, and diarrhea
- mouth and throat pain
- runny nose and sore throat
- upper respiratory tract infection
- respiratory tract infection
- inflammation of the sinuses
- painful and frequent urination (signs of a urinary tract infection)
- 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.
What is the dosage for Trelegy Ellipta?
Dosage And Administration Overview
- Administer 1 actuation of Trelegy Ellipta once daily by oral inhalation.
- After inhalation, rinse the mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
- Trelegy Ellipta should be used at the same time every day. Do not use Trelegy Ellipta more than 1 time every 24 hours.
- No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment.
Recommended Dosage For Maintenance Treatment Of Chronic Obstructive Pulmonary Disease
- The recommended dosage of Trelegy Ellipta for maintenance treatment of COPD is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 100/62.5/25 mcg) once daily by oral inhalation. Trelegy Ellipta 100/62.5/25 mcg is the only strength indicated for the treatment of COPD.
- If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.
Recommended Dosage For Maintenance Treatment Of Asthma
- The recommended starting dosage of Trelegy Ellipta for maintenance treatment of asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 100/62.5/25 mcg) or fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 200/62.5/25 mcg) once daily, by oral inhalation.
- When choosing the starting dosage strength of Trelegy Ellipta, consider the patients’ disease severity; their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage; as well as the patients’ current control of asthma symptoms and risk of future exacerbation.
- The maximum recommended dosage is 1 inhalation of Trelegy Ellipta 200/62.5/25 mcg once daily.
- For patients who do not respond adequately to Trelegy Ellipta 100/62.5/25 mcg once daily, increasing the dose to Trelegy Ellipta 200/62.5/25 mcg once daily may provide additional improvement in asthma control. For patients who do not respond adequately to Trelegy Ellipta 200/62.5/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options.
- If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.
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What drugs interact with Trelegy Ellipta?
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 inhibitors.
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, And QTc Prolonging Drugs
- 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.
- 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.
- 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.
Is Trelegy Ellipta safe to take when pregnant or breastfeeding?
- There are insufficient data on the use of Trelegy Ellipta or its individual components, fluticasone furoate, umeclidinium, and vilanterol, in pregnant women to inform a drug-associated risk.
- There is no information available on the presence of fluticasone furoate, umeclidinium, or vilanterol in human milk; the effects on the breastfed child; or the effects on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trelegy Ellipta and any potential adverse effects on the breastfed child from fluticasone furoate, umeclidinium, or vilanterol or from the underlying maternal condition.
Trelegy Ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma in patients aged 18 years and older. It NOT indicated for the relief of acute bronchospasm. 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).
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Related Disease Conditions
Asthma is a condition in which hyperreactive airways constrict and result in symptoms like wheezing, coughing, and shortness of breath. Causes of asthma include genetics, environmental factors, personal history of allergies, and other factors. Asthma is diagnosed by a physician based on a patient's family history and results from lung function tests and other exams. Inhaled corticosteroids (ICS) and long-acting bronchodilators (LABAs) are used in the treatment of asthma. Generally, the prognosis for a patient with asthma is good. Exposure to allergens found on farms may protect against asthma symptoms.
COPD (Chronic Obstructive Pulmonary Disease)
COPD or chronic obstructive pulmonary disease is a lung condition caused by smoking tobacco, exposure to secondhand smoke, and/or air pollutants. Conditions that accompany COPD include chronic bronchitis, chronic cough, and emphysema. Symptoms of COPD include shortness of breath, wheezing, and chronic cough. Treatment of COPD includes GOLD guidelines, smoking cessation, medications, and surgery. The life expectancy of a person with COPD depends on the stage of the disease.
Asthma: Over the Counter Treatment
Patients who have infrequent, mild bouts of asthma attacks may use over-the-counter (OTC) medications to treat their asthma symptoms. OTC asthma medicines are limited to epinephrine and ephedrine. These OTC drugs are best used with the guidance of a physician, as there may be side effects and the drugs may not be very effective.
There are many unusual symptoms of asthma, including sighing, difficulty sleeping, anxiety, chronic cough, recurrent walking pneumonia, and rapid breathing. These symptoms may vary from individual to individual. These asthma complexities make it difficult to accurately diagnose and treat asthma.
Asthma in Children
Asthma in children manifests with symptoms such as coughing and wheezing. Rates of asthma in children are increasing. Asthma in children is usually diagnosed based on the description of symptoms. Lung function tests may also be used. A variety of medications are used for the treatment of childhood asthma.
Adult-onset asthma is asthma that is diagnosed in people over 20 years of age. Symptoms include wheezing, coughing, shortness of breath and difficulty breathing. Treatment may involve anti-inflammatory medications or bronchodilators.
Exercise-induced asthma is asthma triggered by vigorous exercise. Symptoms include coughing, shortness of breath, chest tightness, wheezing, and fatigue while exercising. Preventing exercise-induced asthma attacks involves using inhaled medicines before exercising, performing warm-up exercises and cooling down afterward, avoiding exercising outdoors when pollen counts are high, restricting exercise when you have a viral infection, and wearing a mask over your nose and mouth when exercising in cold weather.
There are two types of asthma medications: long-term control with anti-inflammatory drugs and quick relief from bronchodilators. Asthma medicines may be inhaled using a metered-dose inhaler or nebulizer or they may be taken orally. People with high blood pressure, diabetes, thyroid disease, or heart disease shouldn't take OTC asthma drugs like Primatene Mist and Bronkaid.
Occupational asthma is a type of asthma caused by exposure to a substance in the workplace. Symptoms and signs include wheezing, chest tightness, and shortness of breath. The usual treatment for occupational asthma involves removal from exposure and the use of bronchodilators and inhaled anti-inflammatory medicines.
COPD vs. Asthma (Differences and Similarities)
COPD (chronic obstructive pulmonary disease) and asthma both have common symptoms like coughing, wheezing, shortness of breath, and a tight feeling in the chest. COPD is caused by tobacco smoking, while asthma is caused by your inherited genetic makeup and their interactions with the environment. Risk factors for asthma are obesity, exposure to cigarette smoke (even secondhand smoke), and personal history of hay fever. There is no cure for either disease, but symptoms can be managed with medication. A person with asthma has a better prognosis and life expectancy than someone with COPD.
COPD vs. Emphysema
COPD (chronic obstructive pulmonary disease) is the term doctors and other healthcare professionals use to describe a group of serious, progressive (worsens over time), chronic lung diseases that include emphysema, chronic bronchitis, and sometimes asthma. The number one cause of COPD or emphysema, is smoking, and smoking is the third leading cause of death in the US.
What are the Four Stages of COPD?
COPD (chronic obstructive pulmonary disease) is a group of diseases that cause an inflammatory reaction and irreversible damage in the lungs. The result is obstruction of normal airflow and breathing difficulties. COPD is a lifelong condition with periods of flare ups, and is not curable in any stage of the disease. Emphysema and chronic bronchitis are the most common diseases that make up COPD.
What Are the Four Types of Asthma?
Asthma is a chronic inflammatory disease of the airways (bronchi). Bronchi generally allow for the passage of air in and out of the lungs. In asthma, these airways develop hypersensitivity, inflammation, and narrowing. This causes difficulty in breathing. The four types are mild intermittent, mild persistent, moderate persistent and severe persistent.
Can asthma go away?
Asthma is a long-term condition for many people, particularly if it first develops when you're an adult. In children, it sometimes goes away or improves during the teenage years, but can come back later in life.
Can People With COPD Get Better?
Chronic obstructive pulmonary disease (COPD) is not curable in any stage of the disease. With early diagnosis and treatment, disease progression and flare-ups can be controlled.
End-Stage COPD: Signs, Symptoms, and Prognosis
Chronic obstructive pulmonary disease (COPD) is a group of diseases causing an inflammatory reaction and irreversible damage to the lungs. They cause obstruction of airflow and difficulty breathing.
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Medications & Supplements
- fluticasone (Flonase, Flonase Allergy Relief)
- fluticasone propionate oral inhaler (Flovent)
- fluticasone furoate nasal spray (Veramyst)
- fluticasone hfa inhaler - oral
- fluticasone disk inhaler - oral, Flovent Rotadisk
- fluticasone propionate (Cutivate)
- fluticasone furoate and vilanterol inhalation powder (Breo Ellipta)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.