Weight gain has not been reported as a side effect with Trelegy Ellipta when used to treat asthma or chronic obstructive pulmonary disease (COPD). The manufacturer conducted 12-week, 24-week and one-year long safety studies to evaluate side effects associated with Trelegy.

Use of inhaled corticosteroids (“steroids) over the long-term has rarely been associated with weight gain. There is a proven link between oral steroid use (for example: prednisone) and weight gain; however, fluticasone acts locally in the lung with minimal systemic absorption into the bloodstream.

• For example, Trelegy Ellipta contains fluticasone, an inhaled corticosteroid. As a single oral inhaler, fluticasone is known as Flovent.
• The product label for Flovent does warn of possible weight gain, but this has not been seen in studies with the Trelegy Ellipta product.
• In addition, the other 2 inhaled medicines in Trelegy, umeclidinium and vilanterol are not linked with weight gain.

Some patients may be fearful of exercising due to the risk of triggering COPD or asthma symptoms. Lack of exercise may lead to weight gain. If you feel your asthma or COPD symptoms are not well-controlled with your treatments or your breathing problems get worse quickly.

The most common side effects with Trelegy include:

• upper respiratory tract infection
• pneumonia
• flu
• bronchitis
• thrush fungal infections (oral candidiasis)
• headache
• back or joint pain
• inflammation of the sinuses
• runny nose, sore throat, cough
• taste disturbance
• constipation
• urinary tract infection
• nausea, vomiting, and diarrhea
• mouth and/or throat pain

These are not all of the side effects that can occur with Trelegy Ellipta. If you have questions or concerns about side effects while using Trelegy Ellipta, contact your health care provider.

• See more Trelegy side effects (in detail).

How do the medicines in Trelegy help with asthma or COPD?

Trelegy combines three orally-inhaled medicines for the once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for treatment of asthma in adult patients:

• fluticasone, a corticosteroid, lowers inflammation (swelling) in the lung airways
• vilanterol, a long-acting beta-agonist (LABA), relaxes the airway muscles
• umeclidinium, an anticholinergic drug, helps to widen the large airways and make breathing easier.

Trelegy Ellipta is not used as a fast-acting (rescue) inhaler for the relief of acute bronchospasm. If you do not have a fast-acting rescue inhaler, such as albuterol (brands include: Proventil HFA, Ventolin HFA, ProAir) contact your health care provider for a prescription.

Bottom Line

• Trelegy Ellipta is not associated with weight gain according to the manufacturer. Long-term clinical studies up to one year long did not identify this as a side effect with this treatment.
• In general, use of inhaled corticosteroids (“steroids”) over the long-term has rarely been associated with weight gain. Fluticasone is an inhaled corticosteroid found in Trelegy, but its use as a component of this medicine has not been linked with weight gain.
• Some of the most common side effects reported for Trelegy Ellipta when used for asthma or COPD include upper respiratory tract infection, bronchitis, sinusitis, sore throat, headache, back pain, and urinary tract infections, among others.

This is not all the information you need to know about Trelegy Ellipta for safe and effective use. Review the full Trelegy Ellipta information here, and discuss this information with your doctor or other health care provider.