Safety

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
Facts checked by a personSourcesFull disclaimer

Breo Ellipta Inhaler: Uses, Dosage, Side Effects, Precautions and Alternates

· 6 min read

Breo Ellipta Inhaler: Uses, Dosage, Side Effects, Precautions and Alternates
Generic namefluticasone furoate/vilanterol trifenatate
Drug classInhaled corticosteroid (ICS) and long-acting beta2-adrenergic agonist (LABA) combination
FormsPowder for inhalation delivered via the Ellipta inhaler device
Breo Ellipta Inhaler: Uses, Dosage, Side Effects, Precautions and Alternates product

Quick overview

Breo Ellipta Inhaler contains fluticasone furoate and vilanterol trifenatate, combining an inhaled corticosteroid with a long-acting beta2-adrenergic agonist. It is a prescription inhaler used for long-term maintenance treatment of COPD and asthma, not for sudden breathing problems. It is used once daily and works by reducing airway inflammation and relaxing airway muscles to make breathing easier.

What is Breo Ellipta Inhaler

Breo Ellipta is a prescription inhaler that combines two medicines, fluticasone furoate and vilanterol trifenatate, used for long-term (maintenance) treatment of COPD and asthma. It is not a rescue inhaler for sudden breathing problems.

Breo Ellipta Inhaler uses

  • Symptomatic treatment of COPD in patients with reduced lung function who have had flare-ups despite regular bronchodilator therapy
  • Regular treatment of moderate to severe asthma in patients who need a medium to high dose inhaled corticosteroid combined with a long-acting beta2-agonist

Benefits of Breo Ellipta Inhaler

  • Asthma Maintenance: Helps control airway inflammation and breathing symptoms in adults with asthma.
  • COPD Maintenance: Helps improve airflow and reduce COPD exacerbations.
  • Airway Opening: Vilanterol relaxes airway muscles for easier breathing.
  • Inflammation Control: Fluticasone furoate reduces airway inflammation.
  • Once-Daily Therapy: Combines an inhaled corticosteroid and long-acting bronchodilator in one inhaler.

How Breo Ellipta Inhaler works

One ingredient, fluticasone furoate, is a corticosteroid that reduces inflammation in the airways. The other ingredient, vilanterol, is a long-acting medicine that relaxes the muscles around the airways, helping to keep them open and making breathing easier.

Breo Ellipta Inhaler dosage

This inhaler is used once daily, either in the morning or evening, but at the same time every day. It must be used regularly, even when you have no symptoms, and should not be used more often than recommended or at higher doses than recommended.

It is not to be used to treat sudden asthma symptoms or a sudden COPD flare-up; a short-acting inhaled bronchodilator should be used for immediate relief instead. After inhaling, rinse your mouth with water without swallowing. Do not shake the inhaler.

This inhaler should not be used in children younger than 12 years for asthma, and it is not approved for COPD in children. Adolescents may be more sensitive to the steroid component, so doctors look to use the lowest effective strength. This medicine should not be stopped without medical supervision, since symptoms may come back.

Age groupDose
18–64 Years1 inhalation once daily; strength depends on the condition
Older Adults (65+ Years)1 inhalation once daily; age alone generally does not require adjustment

Available forms and strengths

  • Powder for inhalation delivered via the Ellipta inhaler device

Side effects of Breo Ellipta Inhaler

Common

  • Headache
  • Nasopharyngitis (common cold symptoms)
  • Upper respiratory tract infection
  • Bronchitis
  • Oropharyngeal pain
  • Cough
  • Sinusitis
  • Back pain
  • Influenza
  • Pharyngitis
  • Hoarseness (dysphonia)
  • Allergic rhinitis
  • Upper abdominal pain
  • Fever
  • Oral thrush (candidiasis of mouth and throat)
  • Joint pain
  • Muscle spasms

Serious

  • Pneumonia, including cases requiring hospitalization and rare fatal cases
  • Heart rhythm changes such as extrasystoles, palpitations, or fast heartbeat
  • High blood pressure or other cardiovascular effects
  • Paradoxical bronchospasm (sudden worsening of wheezing right after a dose)
  • Decreased bone density and increased risk of fractures
  • Adrenal suppression or high cortisol levels (Cushing's syndrome)
  • High blood sugar (hyperglycaemia)
  • Low potassium levels (hypokalaemia)
  • Vision changes, including glaucoma, cataracts, or rare eye conditions like central serous chorioretinopathy
  • Severe allergic reactions including anaphylaxis, angioedema, rash, or hives
  • Slowed growth in children and adolescents
  • Psychological effects such as anxiety, depression, sleep problems, or aggression, particularly in children

Warnings and precautions

  • This medicine must not be used to treat a sudden asthma attack or sudden COPD flare-up. A fast-acting (short-acting) bronchodilator should be used for sudden symptoms instead.
  • Do not use this medicine more often than prescribed, at higher doses than prescribed, or together with other medicines containing a long-acting beta-agonist, since this could cause serious or even fatal heart-related effects.
  • The higher strength of this medicine is not recommended for COPD because of a higher chance of pneumonia and steroid-related side effects.
  • Do not stop taking this medicine suddenly without talking to your doctor, since your symptoms may come back.
  • This medicine should be used carefully in people with severe heart disease because it can affect heart rhythm.
  • People with a severe allergy to milk protein should not use this medicine, since it contains lactose made from milk.
  • This medicine should be used cautiously in people with active or past tuberculosis, other infections, or ocular herpes simplex.
  • There isn't enough human data to know if this medicine is fully safe during pregnancy. Animal studies showed some harmful effects at high doses. It should only be used in pregnancy if the expected benefit to the mother outweighs any possible risk to the baby.
  • It isn't known for certain whether this medicine passes into breast milk, but similar medicines do, so a risk to the breastfed baby can't be ruled out. You and your doctor should decide whether to continue breastfeeding or continue this medicine, weighing the benefits of each.
  • No dose change is needed for people with kidney problems, including severe kidney impairment.
  • People with moderate or severe liver problems can have much higher levels of the steroid component in their body, and should use caution since they may be more likely to experience steroid-related side effects. The maximum recommended strength for these patients is the lower dose.
  • Alcohol isn't known to directly interact with this medicine, but drinking heavily can weaken your immune system over time, which may raise your risk of serious infections like pneumonia that this medicine can also increase.
  • No studies have specifically looked at the effect of this medicine on driving or operating machinery, and no negative effect would be expected based on how the medicine works.

Storage

  • Store below 30°C
  • If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use
  • After removal from the tray, the product may be stored for a maximum period of 1 month
  • Write the date the inhaler should be discarded on the label as soon as it is removed from the tray
  • Any unused medicine or waste material should be disposed of by taking it to your local pharmacy

When to see a doctor

  • Get medical help right away if you have sudden worsening of wheezing or breathing right after using this inhaler.
  • Contact your doctor if your asthma symptoms stay uncontrolled or get worse after starting this medicine, as serious and potentially life-threatening asthma problems can occur.
  • If you notice any change in your vision while using this medicine, you should be checked by an eye doctor, as this could be a sign of cataracts, glaucoma, or a rare eye condition.
  • Call your doctor right away if you have a severe allergic reaction, such as swelling of the face, mouth, tongue, or throat, or trouble breathing.
  • If you think you have taken too much of this medicine, contact your doctor or your local poison control center right away; if symptoms are severe, seek emergency care immediately.

Alternatives

  • Symbicort
  • Advair
  • Dulera
  • Breztri Aerosphere

Watch the video

Video: Breo Ellipta Inhaler: Uses, Dosage, Side Effects, Precautions and Alternates

FAQs

What is Breo Ellipta Inhaler used for?

It is used for long-term maintenance treatment of COPD and asthma, helping to reduce airway inflammation and relax airway muscles. It is not for sudden breathing problems.

How often should Breo Ellipta be used?

It is used once daily, either in the morning or evening, at the same time every day, and should be used regularly even when there are no symptoms.

Can Breo Ellipta be used for a sudden asthma attack or COPD flare-up?

No, it must not be used to treat sudden asthma attacks or sudden COPD flare-ups. A short-acting bronchodilator should be used for immediate relief instead.

What are common side effects of Breo Ellipta Inhaler?

Common side effects include headache, nasopharyngitis, upper respiratory tract infection, bronchitis, cough, sinusitis, back pain, and oral thrush, among others.

Is Breo Ellipta safe to use during pregnancy?

There isn't enough human data to confirm full safety during pregnancy, and it should only be used if the expected benefit to the mother outweighs possible risks to the baby.

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
Facts checked by a personSourcesFull disclaimer

Sources

  1. Australian Product Information - BREO ELLIPTA (fluticasone furoate/vilanterol trifenatate), GlaxoSmithKline Australia Pty Ltd, Version 9.0, 25 October 2018
  2. Healthline - All About Breo Ellipta, https://www.healthline.com/health/drugs/breo-ellipta
  3. Medical News Today - Breo Ellipta (fluticasone furoate/vilanterol trifenatate), https://www.medicalnewstoday.com/articles/drugs-breo-ellipta