Can you take Breztri Aerosphere for asthma?

In this article:

• Why is Breztri not for asthma?
• Breztri limitations of use
• Breztri side effects
• Breztri warning letters

In this article

• Why is Breztri not for asthma?
• Breztri limitations of use
• Breztri side effects
• Breztri warning letters

Breztri Aerosphere is an inhaled medication in the form of a metered dose inhaler. It contains three ingredients: budesonide, formoterol fumarate, and glycopyrrolate. It is approved by the Food & Drug Administration (FDA) for long-term treatment of adults with chronic obstructive pulmonary disease (COPD). 

COPD is a long-term condition that includes either or both of the following:

• Chronic bronchitis: Long-term bronchial inflammation that causes individuals to have a productive cough for more than three months out of two years 
• Emphysema: A lung condition that involves damage to the lungs and shortness of breath, often caused by smoking or air pollution

Breztri helps improve breathing and COPD symptoms, such as wheezing, chest pain or tightness, cough, and shortness of breath. It can also help prevent COPD exacerbation or flare-ups. 

Breztri is not a rescue inhaler and does not treat sudden breathing problems. It is not approved to treat asthma. 

Why is Breztri not for asthma?

Breztri Aerosphere is a combination inhaled medication that contains three active ingredients:

• Budesonide, an inhaled corticosteroid (ICS) 
• Formoterol, a long-acting beta agonist (LABA)
• Glycopyrrolate, a long-acting muscarinic antagonist (LAMA), which is also considered an anticholinergic medication

These three ingredients work together by decreasing inflammation and relaxing the muscles in the lungs and opening the airways, making it easier to breathe. 

Breztri Aerosphere is a metered-dose inhaler. Each puff of inhalation aerosol contains 160 micrograms (mcg) of budesonide, 9 mcg of glycopyrrolate, and 4.8 mcg of formoterol fumarate. The usual dose is two puffs by mouth twice a day. 

Because Breztri Aerosphere is an inhaled medication, people may think it is an asthma treatment. However, Breztri is not approved for use in asthma and does not work as a rescue inhaler. It will not treat sudden breathing problems or an asthma attack, so you still need to keep a rescue inhaler, such as albuterol, with you. Clinical trials have studied Breztri in people with moderate to very severe COPD but not asthma. Therefore, it is not known if Breztri is safe and effective in people with asthma and should not be used to prevent or treat asthma. It is also not approved for use by anyone under the age of 18 years. 

Breztri is approved by the FDA for the maintenance treatment of COPD in adults. It does not treat acutely deteriorating COPD or acute symptoms or flare-ups of COPD. Your healthcare provider will tell you what to do in the event of a COPD exacerbation. You may need to go to the hospital for treatment.

Breztri limitations of use

Something that people with asthma should keep in mind is that a LABA such as formoterol, which is an ingredient in Breztri, should never be used alone. Doing so could increase the risk of hospitalizations and deaths from asthma problems. This effect does not apply to people with COPD. When a LABA is used in combination with an ICS, this risk does not apply. Because Breztri contains three ingredients—two of which are an ICS and LABA—there is not an increased risk of hospitalizations and deaths. Breztri should not be combined with any other LABA or anticholinergic treatment.

Again, Breztri is only approved for use in adults with COPD. It has not been studied in adults or children with asthma. It is not a rescue inhaler and cannot help if you are having sudden breathing problems. You should always keep a rescue inhaler, such as albuterol, with you while using Breztri. 

Always consult your healthcare provider for questions and concerns about your treatment for COPD or asthma. 

RELATED: Breztri alternatives: What can I take instead of Breztri?

Breztri side effects

The most common side effects of Breztri include:

• Upper respiratory tract infections
• Sinus infections
• Cough 
• Flu 
• Pneumonia
• Back pain
• Yeast infection of the mouth and throat (also called thrush, which can occur if you don’t rinse Breztri from the mouth)
• Muscle spasms
• Urinary tract infections
• Diarrhea 

In rare cases, paradoxical bronchospasm may occur. This is a worsening of symptoms after using the inhaler, and it can be life-threatening. Ask your healthcare provider what to do if this occurs. Generally, you will be instructed to stop using Breztri and use your short-acting (rescue) inhaler. Then, your healthcare provider will recommend a different treatment.

In the rare event of an allergic reaction to Breztri, you should seek emergency medical help. Symptoms of an allergic reaction include hives, difficulty breathing or swallowing, and swelling of the face, lips, tongue, or throat. 

Other things to be aware of include:

• Before you use Breztri, tell your healthcare provider about all of your medical conditions, including high blood pressure, heart problems, diabetes, thyroid problems, or any others. Inform them whether you’re pregnant or breastfeeding as well.
• Also inform your healthcare provider about all of the medications you take, including prescription drugs, Over-the-counter medicines, vitamins, and supplements. When you get your prescription, read the patient information leaflet and medication guide and ask your healthcare provider if you have any questions. 
• Steroids can affect the immune system, which can increase the risk of infection. There is an increased risk of pneumonia in people with COPD. Call your healthcare provider right away if you have fever, chills, increased breathing difficulty, or increased cough, especially with increased mucus or a change in the color of mucus.
• Other infections can occur, too. Avoid exposure to infections, especially chickenpox and measles. Let your healthcare provider know if you have any type of infection before or during Breztri treatment, such as a bacterial, viral, or fungal infection. 
• Follow your healthcare provider’s instructions if you are transferring from oral steroids to Breztri. 
• Some people may experience problems with the adrenal glands. Notify your healthcare provider if you have fatigue, weakness, nausea, vomiting, or low blood pressure.
• Your healthcare provider may monitor your bone density before and during treatment to check for osteoporosis. 
• This medication may increase blood sugar and decrease potassium levels. Symptoms of low potassium levels include muscle spasms or weakness and abnormal heart rhythm.
• Long-term use of inhaled cortisteroids may cause other serious side effects such as cataracts (clouding of the lens of the eye) and glaucoma (increased pressure in the eye, which can cause vision loss or blindness). If you have symptoms of eye pain, nausea, vomiting, blurry vision, red eyes, or seeing halos or bright colors around lights, this could be an emergency, and you should see your healthcare provider immediately. 
• Long-term use of ICSs may also cause urinary retention. Let your healthcare provider know if you have painful or difficult urination, frequent urination, or any changes in urination. 
• You should get medical attention right away if you have decreased lung function, your rescue inhalers seem less effective, or you use more puffs of your rescue medicine than usual. 

Breztri warning letters

In 2023, the FDA sent a warning letter to Breztri manufacturer AstraZeneca Pharmaceuticals in regard to a promotional communication, citing “false or misleading claims and/or representations about the efficacy of Breztri,” and that AstraZeneca’s “promotional communication creates a misleading impression regarding the overall benefits a patient may expect as a result of Breztri treatment.” 

The FDA stated that AstraZeneca made claims that Breztri had a positive impact on all-cause mortality and reduced the risk of death in people with COPD, among other claims—and that these claims were misleading because they were not supported by references. 

The FDA noted that these claims are considered misbranding (making false or misleading claims about efficacy) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

AstraZeneca was then given the opportunity to provide supporting information for the claims, along with a plan to correct the communication, provide truthful communication, and other requirements. 

No further information about the outcome of the warning letter is available. However, the medication is still available in pharmacies in the United States. Consult your healthcare provider for more information about Breztri.