Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate)

What is Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for?

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a triple-combination medication used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is available in inhaler form (28 or 120 inhalations) containing 160 mcg budesonide, 9 mcg glycopyrrolate, and 4.8 mcg formoterol fumarate.^[1]

How does Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) work?

COPD is characterized by chronic lung inflammation that leads to airway obstruction. It is a progressive disease that is mainly irreversible. It is the third leading cause of death worldwide.^[1]

Breztri Aerosphere consists of three active ingredients:

Budenoside is an anti-inflammatory corticosteroid. Inhalation of corticosteroids is a commonly used therapy used for the treatment of COPD.^[2]

Glycopyrrolate is an anticholinergic that works as a long-acting bronchodilator. Anticholinergics relax the muscle cells in the lungs, and widens the airways. This so-called bronchodilation will make it easier for patients to breathe.^[3]

Formoterol fumarate is a fast-acting, long-acting selective beta2-adrenergic agonist (beta2-agonist).When inhaled, it functions as a bronchodilator. It does so by activating beta2 receptors. These receptors are present on muscle cells of the lungs, and their activation leads to relaxation of these cells.^[1]

When combined, efficacy of these substances provide better symptom reduction in maintenance therapy of COPD, and will improve quality of life.

Where has Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) been approved?

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) was approved for the maintenance treatment of COPD patients by:

• The Food and Drug Administration (FDA), USA on July 24, 2020.^[4]
• The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on June 19, 2020.^[5]
• National Medical Products Administration (NMPA), China on Dec 23, 2019 under the brand name PT010.^[6]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) taken?

The standard dose range is:^[1]

• 320 mcg budesonide 320 mcg, 18 mcg glycopyrrolate and 9.6 mcg formoterol fumarate

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is administered twice daily by oral inhalation. Two inhalations are taken per moment. Do not take more than two inhalations twice daily.

The Breztri Aerosphere canister has a dose indicator attached to it, to keep track of the remaining inhalations. Patients are advised to only use the inhaler with the dose indicator, so the medicine reaches its target (the lungs) better, and will be more effective.

Complete information about Breztri Aerosphere (glycopyrrolate and formoterol fumarate) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

Are there any known adverse reactions or side effects of Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate)?

Common adverse reactions

The most common adverse reactions (≥20% of patients) listed in the prescribing information include:^[1]

• Upper respiratory tract infection
• Pneumonia
• Back pain
• Thrush in your mouth and throat
• Joint pain
• Flu
• Headache
• High blood sugar levels
• Muscle spasms
• Cough
• Inflammation of the sinuses
• Diarrhea
• Hoarseness
• Painful and frequent urination
• Nausea
• Difficulty sleeping
• Feeling anxious
• Awareness of your heart beating (palpitations)

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Fungal infection in your mouth or throat (thrush)
• Pneumonia
• Immunosuppression
• Reduced adrenal function
• Sudden breathing problems immediately after inhaling your medicine
• Serious allergic reactions
• Increased blood pressure
• Effects on the heart
• Effects on the nervous system
• Bone thinning or weakness (osteoporosis)
• New or worsened eye problems
• Urinary retention
• Changes in laboratory blood values

Use in a specific population

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.

References

1. Summary of Product Characteristics [FDA]: Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) [PDF]
Astra Zeneca, July 24, 2020

2. Inhaled and Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease
Falk, JA, Proc Am Thorac Soc, May 1, 2008

3. Inhaled glycopyrrolate for the treatment of chronic obstructive pulmonary disease
Tashkin DP, Int J Chron Obstruct Pulmon Dis, 2018

4. Breztri Aerosphere approved in the US for the maintenance treatment of COPD
Astra Zeneca press release, July 24, 2020

5. Breztri Aerosphere (PT010) approved in Japan for patients with chronic obstructive pulmonary disease
Astra Zeneca press release, June 19, 2020

6. AstraZeneca’s triple-combination therapy approved in China for patients with COPD
Astra Zeneca press release, Dec. 23, 2020