Breztri Aerosphere (Budesonide, Glycopyrrolate, and Formoterol) - Inhalation

What Is Breztri Aerosphere?

Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol) is a prescription medication that is used as a maintenance treatment for individuals with chronic obstructive pulmonary disease (COPD).

Breztri Aerosphere is unique in the fact that it is a combination medication with three different components to treat COPD. To understand how this medication works, it is essential to understand the individual active ingredients.

Budesonide belongs to a drug class known as inhaled corticosteroids (ICS). A person with COPD receives a limited amount of air due to chronic inflammation of the airways. Budesonide and other ICS drugs work by reducing the inflammation. This class of medications acts by limiting cells and chemicals typically released during an inflammatory response.

Glycopyrrolate is a long-acting antimuscarinic agent. Glycopyrrolate acts on multiple receptors in the body, but its effect primarily blocks M3 receptors, which are a type of muscarinic receptor. Under normal conditions, activation of the M3 receptor results in the airways tightening, making it more difficult to breathe. Inhibiting the M3 receptor helps relax the airways around the lungs, ultimately allowing for more air to pass through.

Formoterol is a long-acting selective beta-2 adrenergic agonist (LABA) that quickly takes effect. It sticks to beta-2 adrenergic receptors throughout the body and cause the muscles in the airways to relax, allowing for more air to pass through.

Breztri Aerosphere is only available by prescription. It is inhaled via a pressured metered dose inhaler.

Drug Facts

Generic Name: Budesonide, glycopyrrolate, and formoterol

Brand Name(s): Breztri Aerosphere

Drug Availability: Prescription

Administration Route: Inhalation

Therapeutic Classification: Anti-inflammatory/bronchodilator combination

Available Generically: No

Controlled Substance: No

Active Ingredient: Budesonide, glycopyrrolate, and formoterol

Dosage Form(s): Pressurized inhalation powder

What Is Breztri Aerosphere Used For?

The Food and Drug Administration (FDA) approved Breztri Aerosphere for the maintenance treatment of individuals with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung condition that includes chronic bronchitis, emphysema, or both.

It is important to note it is used for maintenance only. It should NOT be used to relieve acute symptoms of COPD; you should use a rescue inhaler for the intense flare-ups of shortness of breath.

Breztri Aerosphere (Budesonide, Glycopyrrolate, and Formoterol) Drug Information : A person's lungs on their chest

Verywell / Dennis Madamba

How to Take Breztri Aerosphere

Breztri Aerosphere is an inhaler for oral inhalation only. You should always follow directions given to you by your healthcare provider on how to take it, but generally, it is prescribed to take two inhalations twice daily.

Before your first use, you must remember to prime the inhaler to make sure you get the appropriate dose.

To prime the inhaler:

  • Remove the cap from the inhaler's mouthpiece.
  • Hold the inhaler in an upright position away from your face and shake it well.
  • Hold the inhaler with your thumb supporting the base and your first two fingers on the dose indicator at the top.
  • Press down on the dose indicator until the canister no longer moves to release a puff from the inhaler.
  • Shake and press on the dose indicator three more times.

After priming it four times, your inhaler is ready for use. If you drop your inhaler or don't use it for more than seven days, you must reprime it before using it again. To reprime your inhaler, shake it well and press the dose indicator on top twice to release two puffs away from your face.

To use your inhaler:

  • Shake the inhaler well before each use.
  • Remove the cap from the mouthpiece.
  • Hold the inhaler with the mouthpiece pointing toward you and exhale through your mouth completely.
  • Close your lips around the mouthpiece and tilt your head back, keeping your tongue below the mouthpiece. While breathing in deeply and slowly, press down on the dose indicator until the canister stops moving down to release one puff from the inhaler. Then, stop pressing the dose indicator.
  • When you have finished breathing in, remove the mouthpiece from your mouth.
  • Hold your breath as long as you comfortably can, up to 10 seconds. Breathe out slowly and repeat the steps above to take your second dose from the inhaler.
  • Replace the cap over the mouthpiece immediately after use.
  • Rinse your mouth with water (do not swallow) to remove excess medicine, as budesonide (a steroid) can cause thrush.

It is recommended to clean the inhaler at least every seven days. You will need to prime it again after cleaning. To clean, remove the canister from the actuator, and run warm water through the actuator for approximately 30 seconds. Then, turn the actuator upside down and run warm water through it again for another 30 seconds, and allow it to air dry completely.

Storage

Store Breztri Aerosphere in a cool, dry place in its original package. Only open the foil pouch when you are ready to use it. Throw the medication away three months after opening it (for the 120-inhalation canister) or three weeks after opening the foil pouch (for the 28-inhalation canister), or when the counter reads zero, whichever comes first.

Medications should be kept away from hot or humid areas, such as your kitchen or bathroom. You should also keep Breztri Aerosphere away from bright light exposure. These environments can impact how well medications work. It is also essential to ensure this medication is kept away from children and pets to avoid accidental consumption.

Generally, it is best to contact your pharmacist at least a week before you run out of the medication to put in a refill request.

How Long Does Breztri Aerosphere Take to Work?

Breztri Aerosphere has several active ingredients, but formoterol has the quickest effect. Formoterol is expected to work within one to three minutes and has a sustained impact for upwards of 12 hours. Breztri Aerosphere improved lung function in clinical trials when used for 24 to 52 weeks.

What Are the Side Effects of Breztri Aerosphere?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

The common side effects of Breztri Aerosphere include:

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects can include the following:

 Long-Term Side Effects

Long-term use of this medication has been associated with decreased bone mineral density (BMD). Low BMD for an extended period may lead to a condition called osteoporosis (weak bones). It is important to have your BMD assessed before starting this medication and periodically afterward. Speak with your healthcare provider to consider therapy to treat or prevent osteoporosis if low BMD becomes a concern.

Report Side Effects

Breztri Aerosphere may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Breztri Aerosphere Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For inhalation dosage form (aerosol):
    • For COPD:
      • Adults—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 160 micrograms (mcg) budesonide, 9 mcg glycopyrrolate and 4.8 mcg formoterol.
      • Children—Use is not recommended.

Modifications

Your healthcare provider will closely monitor you if you have severe liver impairment, severe kidney impairment from end-stage kidney disease (ESKD), or are on dialysis. Talk to your healthcare provider if you are breastfeeding, pregnant, or planning to get pregnant, as this medication is only recommended if the expected benefit outweighs the potential risk.

Missed Dose

If a dose is missed, you should take it as soon as you remember. If the time is close to your next scheduled dose, you should omit the missed dose and take the next dose as scheduled. Do not take more than one dose to make up for a forgotten dose.

Overdose: What Happens If I Take Too Much Breztri Aerosphere?

No cases of overdose have been reported with Breztri Aerosphere. Potential risks of overdose would come from overdose with its ingredients individually. 

High doses of budesonide for an extended period may result in hypercorticism (also known as Cushing's disease), which has symptoms of:

  • Weight gain in the upper back or belly
  • Moon face
  • Bad headache
  • Slow healing

High doses of glycopyrrolate can lead to:

  • Nausea
  • Vomiting
  • Dizziness
  • Lightheadedness
  • Blurred vision
  • Increased eye pressure
  • Difficulty passing a stool due to a blockage
  • Difficulty with urinating.

An overdose of formoterol can lead to several symptoms, such as:

  • Seizures
  • Chest pain
  • High blood pressure
  • Low blood pressure
  • High heart rate
  • Heart arrhythmias
  • Palpitations
  • High blood sugar
  • Low potassium levels

What Happens If I Overdose on Breztri Aerosphere?

If you think you or someone else may have overdosed on Breztri Aerosphere, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Breztri Aerosphere, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a sudden COPD attack, or if symptoms of COPD attack has already started. Your doctor will give you a short-acting inhaler to use for this condition. If the short-acting inhaler is not working, tell your doctor right away.

Talk to your doctor or get medical care right away if:

  • Your symptoms do not improve after using this medicine for a few days or if they become worse.
  • Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

Do not use this medicine together with other inhaled medicines for COPD, including arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), olodaterol, salmeterol (Serevent®), or vilanterol.

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death, especially in patients with asthma who take bronchodilators without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

You may get infections more easily while using this medicine. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

Patients with COPD may be more likely to have pneumonia when using this medicine. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, or wheezing.

If you develop a skin rash, hives, swelling of the tongue, lips, or face, or any allergic reaction to this medicine, check with your doctor right away.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

Call your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.

Check with your doctor right away if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine, or painful urination.

Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe COPD attack or other illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Breztri Aerosphere?

This medication is not recommended for children, as there are no studies related to safety or how well the drug works in this age group. People with asthma should also not be using this medication due to the same lack of information. You should NOT take Breztri Aerosphere if you have ever experienced a severe allergic reaction to its ingredients: budesonide, glycopyrrolate, or formoterol.

What Other Medications Interact With Breztri Aerosphere?

To know which medications interact with Breztri, it is important to understand how it is converted in the body. The ingredient budesonide is eliminated from the body by a class of proteins known as cytochrome P450 isoenzyme 3A4 (CYP3A4). Since it is broken down by this protein, drugs that decrease the rate at which these proteins work (known as inhibitors) can increase the amount of budesonide in the body.

Some common inhibitors of CYP3A4 are listed below:

Breztri Aerosphere contains a beta-2 agonist (formoterol). Therefore, other drugs that affect this receptor should be used with caution. Medications that also act on beta-2 receptors include:

  • Adrenaclick, Adrenalin, Auvi-Q, EpiPen, Primatene Mist, Symjepi (epinephrine)
  • Akovaz, Corphedra, Rezipres (ephedrine)
  • Dobutamine
  • Levophed (norepinephrine)

Drugs that work against beta-2 receptors (known as beta-blockers) may decrease how well Breztri Aerosphere works and vice versa. If a beta-blocker is needed, your healthcare provider may select one that is more specific to the heart. However, they should still be used with caution.

Examples of beta-blockers include:

Other medications that should be used with caution if taken with Breztri Aerosphere include:

What Medications Are Similar?

Trelegy (fluticasone, umeclidinium, and vilanterol) is another medication that uses three ingredients within a single inhaler.

There are also other combination inhalers with two components, such as:

  • Dulera (mometasone and formoterol)
  • Advair Diskus, Advair HFA, AirDuo Digihaler, Airduo Respiclick (fluticasone and salmeterol)
  • Symbicort (budesonide and formoterol)
  • Breo Ellipta (fluticasone and vilanterol) 

This list is a list of drugs also prescribed for the targeted condition(s). It is NOT a list of medicines recommended to take with Breztri Aerosphere. You should not take these drugs together. Ask your pharmacist or a healthcare provider if you have questions.

Frequently Asked Questions

  • What is Breztri Aerosphere used for?

    Breztri Aerosphere is used as a maintenance treatment for those with severe COPD. Typically it is used when your COPD is moderate or severe and if you have had multiple COPD exacerbations.

  • What are the side effects of Breztri Aerosphere?

    The most common side effects of Breztri Aerosphere are an increased risk of developing an upper respiratory infection, increased risk of pneumonia, coughing, or oral thrush. To prevent oral thrush with the budesonide component, it is important always to rinse your mouth with water and spit it out after each inhalation.

  • How expensive is Breztri Aerosphere?

    Breztri Aerosphere is a relatively expensive medication. A 30-day supply can cost about $600 on average without insurance. There is currently no equivalent generic medication on the market. While the medication may be expensive, there may be a savings program available from the manufacturer that could potentially lower the cost of your prescription.

How Can I Stay Healthy While Taking Breztri Aerosphere?

Taking Breztri Aerosphere regularly and as directed by your healthcare provider is important to staying healthy and maintaining control of your COPD.

Additionally, if you have COPD, you can make other lifestyle choices to stay healthy and reduce your symptoms, such as stopping smoking. While quitting smoking will not cure the disease, it can slow its progression. Many helpful programs and medications can help as you quit smoking. Talk with your healthcare provider to discuss which options would be best for you.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some drug content, as indicated on the page.

The author would like recognize and thank Cody Ryan Thomas for contributing to this article.

6 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Breztri label.

  2. Angelis N, Porpodis K, Zarogoulidis P, et al. Airway inflammation in chronic obstructive pulmonary disease. J Thorac Dis. 2014;6 Suppl 1(Suppl 1):S167-S172. doi:10.3978/j.issn.2072-1439.2014.03.07

  3. Young H. Budesonide/Glycopyrronium/Formoterol: a review in COPD. Drugs. 2021;81:1411-1422. doi:10.1007/s40265-021-01562-6

  4. Martinez F, Rabe K, Ferguson G, et al. Reduced all-cause mortality in the ETHOS trial of budesonide/glycopyrrolate/formoterol for chronic obstructive pulmonary disease. A randomized, double-blind, multicenter, parallel-group study. Am J Respir Crit Care Med. 2021;203(5):553-564. doi:10.1164/rccm.202006-2618OC

  5. AstraZeneca. Cost assistance with Breztri.

  6. van Eerd E, van der Meer R, van Schayck O, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016;2016(8):CD010744. doi:10.1002/14651858.CD010744.pub2