Trelegy Ellipta is a combination inhaled medication used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma in adults. The medication works by combining an inhaled corticosteroid (fluticasone), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta2-adrenergic agonist (vilanterol) to reduce inflammation, relax the airway muscles, and keep the airways open. While highly effective for managing symptoms, patients should be aware of the potential side effects, which can vary in frequency and severity.
Common Side Effects
In clinical trials, several adverse reactions were reported with an incidence rate greater than or equal to 1%, and these varied slightly depending on whether the medication was used for COPD or asthma.
- Upper Respiratory Tract Infections: This was a frequently reported side effect for both COPD and asthma patients, often presenting as common cold symptoms like a runny nose, stuffy nose, or sore throat.
- Headache: Headaches were commonly reported by patients using Trelegy for either condition.
- Back Pain: Another common musculoskeletal issue identified in trials was back pain.
- Oral Thrush: A fungal infection of the mouth and throat, known as oral candidiasis, was reported. To help prevent this, patients are advised to rinse their mouths with water and spit it out after each dose.
- Cough: Some patients experience a cough as a side effect.
- Other common effects: Additional common side effects include changes in taste (dysgeusia), diarrhea, and influenza. For asthma patients, pharyngitis (sore throat) and sinusitis (sinus infection) were also noted.
Managing common side effects
For mild, temporary side effects like a sore throat or hoarseness, simple measures can help. Staying hydrated by drinking plenty of fluids is often beneficial. To prevent oral thrush, the single most important action is to rinse your mouth thoroughly with water and spit it out immediately after each use of the inhaler. If symptoms persist or become bothersome, discuss them with your healthcare provider.
Serious and Less Common Side Effects
While most side effects are manageable, some rare but serious issues can occur, requiring immediate medical attention.
- Pneumonia: Studies have shown an increased risk of pneumonia in COPD patients taking Trelegy. Symptoms to watch for include fever, chills, increased mucus production or a change in its color, and increased breathing difficulty.
- Cardiovascular Effects: As with other beta-agonists, the vilanterol component can cause clinically significant cardiovascular effects in some individuals. This includes increased blood pressure and heart rate, chest pain, and irregular heartbeats. Patients with pre-existing heart conditions should be monitored closely.
- Paradoxical Bronchospasm: This is a severe, life-threatening reaction where the airways suddenly tighten immediately after inhaling the medication. If this occurs, stop the medication immediately and seek emergency medical help.
- Weakened Immune System: The corticosteroid component (fluticasone) can weaken the immune system, increasing susceptibility to infections like chickenpox and measles. Patients should be cautious around people who are sick.
- Osteoporosis: Long-term use of inhaled corticosteroids can lead to decreased bone mineral density, increasing the risk of osteoporosis and fractures. Patients with existing risk factors should be monitored.
- Eye Problems: Use of Trelegy can increase the risk of eye issues such as glaucoma or cataracts. Symptoms include blurred vision, eye pain, seeing halos around lights, and red eyes. Regular eye exams are recommended for long-term users.
- Adrenal Insufficiency: In some cases, prolonged use can suppress the body's natural steroid hormone production. This is especially relevant when transferring from oral steroids. Symptoms include weakness, fatigue, and nausea.
- Urinary Retention: The umeclidinium component can cause or worsen urinary retention, particularly in men with an enlarged prostate. Symptoms include difficulty or pain when urinating.
- Allergic Reactions: Severe allergic reactions are possible, with symptoms including hives, rash, and swelling of the face, tongue, or throat. Patients with severe milk protein allergy should not use Trelegy due to the lactose content in the inhaler.
Comparison of Common Side Effects by Condition
While many side effects overlap, the incidence can vary between COPD and asthma patients, as shown in clinical trial data.
| Side Effect | Incidence in COPD Patients | Incidence in Asthma Patients |
|---|---|---|
| Upper Respiratory Tract Infections | Common (approx. 5-7%) | Very Common (up to 17%) |
| Pneumonia | More Common | Less Common (around 1-2%) |
| Oral Thrush | Common | Common |
| Headache | Common | Common |
| Back Pain | Common | Common |
| Pharyngitis / Sore Throat | Common | Very Common (up to 17%) |
| Bronchitis | Common | Common |
| Sinusitis / Sinus Infection | Common | Common |
| Urinary Tract Infection (UTI) | Common | Common |
Conclusion
Trelegy Ellipta is an effective long-term maintenance therapy for adults with COPD and asthma. While many people tolerate it well, understanding potential side effects is essential. The most common side effects often include respiratory infections, headaches, and oral thrush, which can frequently be managed with simple preventative steps like rinsing the mouth. More serious side effects, such as pneumonia, cardiovascular issues, or osteoporosis, are less common but require vigilant monitoring and prompt communication with a healthcare provider. As with any prescription medication, the decision to use Trelegy involves weighing the potential benefits against the risks, and this should always be done in consultation with a qualified medical professional. For detailed prescribing information, consult the official FDA document for Trelegy Ellipta.
