INCREASED RISK OF HOSPITALIZATIONS AND DEATH FROM ASTHMA-RELATED EVENTS: Trelegy Ellipta contains vilanterol which is a long-acting beta-2 adrenergic agonist (LABA). Data from clinical studies has shown that LABA monotherapy (use of LABAs alone without inhaled corticosteroids or ICS) is associated with a higher risk of asthma-related hospitalization and asthma-related death in pediatric and adolescent patients. However, large clinical trials have not shown a significant increase in risk with use of LABA/ICS fixed dose combination. 

NOT FOR ACUTE EPISODES OR RAPIDLY DETERIORATING DISEASE: Taking Trelegy Ellipta is not recommended for relief of acute symptoms (sudden trouble breathing). Your doctor will prescribe a rescue inhaler (short-acting beta-2 agonist) for this purpose. If you have been using a rescue inhaler regularly (more than 4 times a day), your doctor will ask you to only use a rescue inhaler only when needed after you start using Trelegy Ellipta.

Trelegy Ellipta use has not been studied in patients experiencing a rapid deterioration in COPD or life-threatening episodes of asthma or COPD. Treatment with this inhaler should not be started in patients experiencing sudden worsening or severe episodes of COPD or asthma. Tell your doctor if you notice the 100/62.5/25 mcg dose of Trelegy Ellipta is no longer able to control your symptoms or if you need to use a rescue inhaler (short-acting beta2-agonist) more frequently. These can be signs of deteriorating disease. Do not use Trelegy Ellipta more frequently (more than 1 actuation in 24 hours) if you have worsening symptom control. 

RISK OF OVERDOSE: Do not use Trelegy Ellipta more than once in 24 hours or at higher doses than prescribed. Also, do not take other long-acting beta agonists (LABAs) while using Trelegy Ellipta because this can result in an overdose. Examples of LABAs include salmeterol, formoterol, arformoterol, and indacaterol.

ORAL CANDIDIASIS: Trelegy Ellipta contains an inhaled corticosteroid (ICS), fluticasone furoate. Using Trelegy Ellipta can increase the risk of local fungal infections in the mouth and throat with Candida albicans (oral candidiasis). Rinsing your mouth with water (without swallowing) after each dose of Trelegy Ellipta can lower the risk of oropharyngeal candidiasis. If you develop a fungal infection, you may need to take topical (local) or systemic (oral) antifungal drugs. Some patients may even need to interrupt Trelegy Ellipta treatment until the fungal infection clears. 

PNEUMONIA: There are reports of lower respiratory tract infections, including pneumonia, in patients treated with inhaled corticosteroids such as fluticasone, which is one of Trelegy Ellipta’s active drugs. Your doctor will monitor you carefully for signs and symptoms of pneumonia as they can be similar to COPD exacerbations (flares). Seek immediate medical care for cough, changes in sputum color, fever, shortness of breath, or chest pain.

IMMUNOSUPPRESSION AND INCREASED RISK OF INFECTIONS: Corticosteroids suppress the immune system and can increase the risk of getting infections and having more severe infections. For instance, infections such as chickenpox and measles can be more serious, even fatal, in patients taking corticosteroids. It is unclear if corticosteroid administration in an inhaler form affects this risk.

To lower your risk, ensure you have taken all the recommended immunizations. Avoid contact with people who are sick with chickenpox or measles. Tell your doctor if you are exposed to someone with chickenpox or measles during Trelegy Ellipta treatment. Your doctor may recommend prophylaxis (prevention) with varicella zoster immune globulin (VZIG) for chickenpox or pooled intramuscular immunoglobulin (IG) for measles. 

In addition, inhaled corticosteroids should be used with caution in people with ocular herpes simplex, active or quiescent tuberculosis, respiratory tract infections, and other fungal, viral, bacterial, or parasitic infections.

TRANSITION FROM SYSTEMIC CORTICOSTEROID THERAPY: The hypothalamic-pituitary-adrenal (HPA) axis controls cortisol levels and the stress response in the body. When you take systemic corticosteroids (for example, oral corticosteroids), these drugs suppress the HPA axis. It can take several months for HPA function to return to normal after withdrawal from corticosteroids. Caution is therefore necessary when patients are transitioned from systemic (oral) corticosteroids to inhaled corticosteroids that provide lower doses of steroids to the body. Transitioning too quickly can result in HPA axis suppression and adrenal insufficiency, which can be fatal. 

Signs and symptoms of adrenal insufficiency include tiredness, weakness, low energy, low blood pressure, nausea, and vomiting.

Risk factors for HPA axis suppression and adrenal insufficiency include long-term use of steroids, high doses of oral corticosteroids, and complete withdrawal from oral steroids when starting inhaled corticosteroids. To lower the risk, your doctor will gradually lower the dose of oral steroids when they prescribe Trelegy Ellipta.

People who have been withdrawn from systemic corticosteroids need to resume large doses of oral steroids immediately during severe exacerbations of COPD, severe asthma attacks, or periods of stress. Such individuals should carry a warning card indicating the need for supplementary systemic corticosteroids for sudden symptoms.

In addition, stopping treatment with systemic corticosteroids can unmask symptoms that were suppressed by the steroid medicine, such as rhinitis, conjunctivitis, arthritis, and eczema.

Patients coming off systemic corticosteroids may experience systemic symptoms such as joint pain, muscle pain, low energy, and depression despite improvement in lung function. 

HYPERCORTICISM AND ADRENAL SUPPRESSION: The use of Trelegy Ellipta, which contains an inhaled corticosteroid (fluticasone furoate), has not been found to affect the HPA axis at therapeutic doses, even though the steroid medicine is absorbed into the circulation and can have systemic effects. However, taking more than the recommended dosage or taking certain other medicines that can cause HPA dysfunction can increase the risk. 

In addition, some sensitive patients can develop systemic corticosteroid effects after Trelegy Ellipta use, especially during periods of stress or postoperatively. If such effects occur, healthcare providers may recommend reducing the dose of Trelegy Ellipta or switching to some other medicine for COPD and asthma symptoms. 

DRUG INTERACTIONS: Trelegy Ellipta can interact with other medications called CYP3A4 inhibitors (for example, certain antifungal drugs, HIV medicines, and antibiotics). This can lead to increased levels of corticosteroids in the body and an increased risk of cardiovascular adverse effects. 

PARADOXICAL BRONCHOSPASM: Inhaled treatments, including Trelegy Ellipta, can lead to potentially life-threatening paradoxical bronchospasm (narrowing of the airways). If you develop sudden trouble breathing after taking Trelegy Ellipta, use a rescue inhaler immediately. Tell your doctor so they can switch you over to some other medicine for COPD or asthma symptoms.

SEVERE HYPERSENSITIVITY REACTIONS: There are reports of hypersensitivity reactions, including a mild allergic reaction (skin rash, hives, itching) and a more severe allergic reaction such as anaphylaxis (throat closing) or angioedema (swelling) after taking Trelegy Ellipta. Stop using Trelegy Ellipta and seek emergency medical care if this happens. 

Anaphylactic reactions have also been reported in people with severe milk protein allergy after use of Trelegy Ellipta and other powder medications that contain milk proteins like lactose. Tell your doctor if you have a severe milk protein allergy - your provider will not prescribe Trelegy Ellipta in that case. 

CARDIOVASCULAR RISKS: One of Trelegy Ellpita’s active drugs, vilanterol, and other beta2-agonists, can cause serious cardiovascular effects in some people, including increased pulse rate, increased blood pressure, and cardiac arrhythmias (heart rhythm abnormalities) such as supraventricular tachycardia and extrasystoles. You will need to stop Trelegy Ellipta treatment if you develop these complications. 

Beta agonists can also cause ECG changes such as ST segment depression, T wave flattening, and prolongation of the QTc interval. High doses of inhaled beta agonists can be fatal. 

Tell your doctor if you have a history of high blood pressure, coronary artery disease, or heart arrhythmias before starting maintenance treatment with Trelegy Ellipta. 

DECREASED BONE MINERAL DENSITY: Long-term use of inhaled corticosteroids such as fluticasone can lead to a decrease in bone mineral density, which can lead to osteoporosis and a higher risk of bone fractures. Other risk factors for decreased bone mineral density include a family history of osteoporosis, older age, postmenopausal status, smoking, prolonged immobilization, poor nutrition, and chronic use of drugs that decrease bone mass (oral steroids, anticonvulsant drugs). 

Your doctor may measure bone mineral density (BMD) before prescribing Trelegy Ellipta and periodically while you are on it. You may need to start treatment for osteoporosis if a significant decrease in BMD occurs. 

EYE PROBLEMS: Long-term use of inhaled corticosteroids and inhaled anticholinergics (two of the active ingredients in Trelegy Ellipta) has been linked to eye problems including cataracts and glaucoma (increased intraocular pressure). Tell your doctor if you have a history of narrow-angle glaucoma. Seek immediate medical care for eye pain, blurred vision, images with halos, changes in color vision, eye redness, or swelling. You will likely need to see an ophthalmologist (eye doctor) if you develop eye problems.

WORSENING URINARY RETENTION: One of the ingredients in Trelegy Ellipta, umeclidinium, belongs to a group called anticholinergic medicines. Anticholinergic medications should be used with caution in people with urinary retention. Seek immediate medical care if you develop pain with urination or difficulty passing urine. Tell your doctor if you have a history of benign prostatic hyperplasia (prostate enlargement) or bladder neck obstruction. 

WORSENING OF OTHER MEDICAL CONDITIONS: Sympathomimetic amines, which are one of the ingredients in Trelegy Ellipta, can cause worsening of health conditions such as seizure disorders, thyrotoxicosis (dangerously high thyroid hormone levels), ketoacidosis, and diabetes mellitus. Give your doctor a complete medical history before starting treatment with Trelegy Ellpita. 

METABOLIC AND ELECTROLYTE ABNORMALITIES: Beta-adrenergic agonists, which are one of the ingredients in Trelegy Ellipta, can cause hypokalemia (low potassium), which can lead to cardiovascular adverse effects. In addition, these drugs can lead to temporary hyperglycemia (increased blood sugar levels) in some people.

EFFECTS ON GROWTH: Inhaled corticosteroids can lead to decreased growth rates in children and adolescents. However, Trelegy Ellipta is not approved for use in children and adolescents.