Breztri

Breztri is used for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults and asthma in adults and children 12 years and older. Breztri Aerosphere is a triple therapy inhaler containing budesonide (a corticosteroid), formoterol fumarate (a long-acting beta2-agonist, LABA), and glycopyrrolate (an anticholinergic). Breztri is used as 2 inhalations, 2 times each day (2 puffs in the morning and 2 puffs in the evening) to improve long-term symptoms of COPD, help with breathing, and reduce the number of flare-ups (the worsening of your COPD or asthma symptoms for several days).

• Breztri Aerosphere, Breztri inhaler, and Breztri are all interchangeable names for the same medicine.

Breztri inhaler was recently approved for asthma on April 28, 2026. Breztri Aerosphere is used to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing in adults and children 12 years of age and older. It contains formoterol fumarate. LABA medicines, such as formoterol fumarate, when used alone, increase the risk of hospitalizations and death from asthma problems. Breztri contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is no significant risk in hospitalizations and deaths from asthma problems.

Breztri Aerosphere is not to be used to relieve sudden breathing problems and will not replace a rescue inhaler. Always have a rescue inhaler (such as albuterol) with you to treat sudden breathing problems. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed. Breztri is not for the treatment of asthma.

Breztri should not be used for asthma in children younger than 12 years of age. It is not known if it is safe and effective in children this young.

Breztri (budesonide, formoterol, and glycopyrrolate) first gained FDA approval on July 23, 2020. There is no generic.

Read the step-by-step instructions for using Breztri in the ‘Instructions for Use’ provided on the Breztri website or Package Insert. Before using Breztri, make sure your healthcare provider has taught you how to use the inhaler, and you understand how to use it correctly. Use Breztri exactly as your healthcare provider tells you to use it. Do not use Breztri more often than prescribed.

• Use 2 inhalations of Breztri, 2 times each day (2 puffs in the morning and 2 puffs in the evening).
• Do not take more than 2 inhalations of Breztri 2 times each day.
• Rinse your mouth with water and spit the water out after each dose (2 puffs) of Breztri. Do not swallow the water. This will help to reduce the chance of getting a fungal infection (thrush) in the mouth and throat.
• Do not spray Breztri in your eyes. If Breztrigets in your eyes, rinse them well with water. If redness continues, call your healthcare provider.
• Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic-containing medicines.
• Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed.

Breztri does not relieve sudden breathing problems, and you should not take extra doses of Breztri to relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

Prime Breztri Aerosphere before first-time use and re-prime if not used for more than 7 days.

Call your healthcare provider or get emergency medical care right away if:

• Your breathing problems get worse.
• You need to use your rescue inhaler more often than usual.
• Your rescue inhaler does not work as well to relieve your symptoms.

Do not use Breztri Aerosphere:

• to treat sudden, severe symptoms of COPD or asthma
• if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the other ingredients in your Breztri inhaler (see the ingredient list near the bottom of this guide).

Before using Breztri, tell your healthcare provider about all of your medical conditions, including if you:

• Have heart problems
• Have high blood pressure
• Have seizures
• Have thyroid problems
• Have diabetes
• Have liver problems
• Have kidney problems
• Have weak bones (osteoporosis)
• Have an immune system problem
• Have eye problems such as glaucoma or cataracts. Breztri aerosphere may make your glaucoma worse
• Have prostate or bladder problems, or problems passing urine. Breztri may make these problems worse
• Have any type of viral, bacterial, parasitic, or fungal infection
• Are exposed to chickenpox or measles
• Are pregnant, or plan to become pregnant
• Are breastfeeding.

Pregnancy

It is not known if Breztri may harm your unborn baby.

Breastfeeding

It is not known if the medicines in Breztri Aerosphere pass into your breast milk and if they can harm your baby. You and your healthcare provider should decide if you will take Breztri Aerosphere while breastfeeding.

Common Side Effects

The most common side effects of Breztri are:

• Upper respiratory tract infection
• Pneumonia
• Back pain
• Thrush in your mouth and throat. Rinse your mouth with water and spit out without swallowing after use to help prevent this
• Joint pain
• Flu
• Headache
• High blood sugar levels
• Muscle spasms
• Cough
• Inflammation of the sinuses
• Diarrhea
• Hoarseness
• Painful and frequent urination (signs of a urinary tract infection)
• Nausea
• Difficulty sleeping
• Feeling anxious
• Awareness of your heart beating (heart palpitations).

Serious Side Effects and Warnings

Breztri can cause the following serious side effects:

• Fungal Infections in Your Mouth or Throat (Thrush). Breztri inhaler may increase your risk of fungal infections in your mouth and throat. Rinse your mouth with water and then spit it out (do not swallow) after using Breztri Aerosphere to help reduce your chance of getting thrush.
• Pneumonia. People with COPD and asthma are at a higher risk of getting pneumonia. Breztri Aerosphere may increase your risk of pneumonia. Call your healthcare provider if you notice any of the following symptoms: Increase in mucus (sputum) production Change in mucus color Fever Chills Increased cough Increased breathing problems.
• Weakened Immune System and Increased Risk of Getting Infections (Immunosuppression). Breztri can lower your immune system response and increase your risk of developing infections. Call your healthcare provider immediately if you develop signs of an infection, which may include: Fever, chills, fatigue, body aches, swollen lymph nodes, night sweats Redness, warmth, swelling, pus, increasing pain, red streaks spreading outward from a wound Painful/burning urination, frequent urge to urinate, cloudy or bloody urine, pelvic pain Persistent cough, chest pain, shortness of breath, colored mucus, wheezing Confusion (especially in the elderly), rapid heartbeat, dizziness, nausea/vomiting.
• Reduced Adrenal Function (Adrenal Insufficiency). Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as Breztri inhaler). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD or asthma symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include: Feeling tired Lack of energy Weakness Nausea and vomiting Low blood pressure (hypotension).
• Sudden Breathing Problems Immediately After Inhaling Your Medicine. If you have sudden breathing problems immediately after inhaling Breztri, stop using it and call your healthcare provider right away.
• Serious Allergic Reactions. There is a risk of serious allergic reactions with Breztri. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction after using your Breztri inhaler: Rash Hives Swelling of your face, mouth, and tongue Breathing problems.
• Effects on Your Heart. Breztri may affect your heart. Tell your healthcare provider immediately if your blood pressure increases or you develop a fast or irregular heartbeat or chest pain after using Breztri.
• Effects on Your Nervous System. Breztri may affect your nervous system. Tell your healthcare provider immediately if you develop a tremor or if you find yourself more anxious or nervous after using Breztri.
• Bone Thinning or Weakness (Osteoporosis). Breztri may reduce your bone density and cause bone thinning or weakness (osteoporosis). Talk to your healthcare provider about monitoring with bone density scans.
• Slowed Growth in Children. A child's growth should be checked regularly while using Breztri Aerosphere.
• New or Worsened Eye Problems Including Acute Narrow-Angle Glaucoma and Cataracts. Breztri may cause new or worsened eye problems, including acute narrow-angle glaucoma and cataracts. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma include: Eye pain or discomfort Nausea or vomiting Blurred vision Seeing halos or bright colors around lights Red eyes.

If you have these symptoms, call your healthcare provider right away before taking another dose.

• Urinary Retention. People who take Breztri Aerosphere may develop new or worsening urinary retention. Symptoms of urinary retention may include:

• Difficulty urinating Urinating frequently Painful urination Urination in a weak stream or drips.

If you have these symptoms of urinary retention, stop taking Breztri Aerosphere and call your healthcare provider right away before taking another dose

• Changes in Laboratory Blood Values. Changes in laboratory test results, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), have been reported after using Breztri. Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or an abnormal heart rhythm.

Notes:

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Breztri. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to AstraZeneca at 1-800-236-9933.

Breztri combines 3 medications (budesonide, formoterol, and glycopyrrolate) with 3 complementary mechanisms of action for COPD and asthma treatment. Budesonide is a potent anti-inflammatory corticosteroid that inhibits multiple inflammatory cells and mediators involved in COPD and asthma pathogenesis. Glycopyrrolate is a long-acting anticholinergic that blocks muscarinic receptors in airway smooth muscle, causing bronchodilation. Formoterol fumarate is a rapid-acting, long-lasting beta2-agonist (LABA) that relaxes bronchial smooth muscle by increasing cyclic AMP levels.

Breztri inhaler belongs to the drug class called combination inhalers.

Note: The asthma dose of Breztri Aerosphere (160 mcg/18 mcg/4.8 mcg) contains 18 mcg of glycopyrrolate per inhalation, which is twice the 9 mcg found in the COPD formulation (160 mcg/9 mcg/4.8 mcg). The doses of the other ingredients remain the same.

Dose of Breztri for COPD Maintenance Treatment

• 2 inhalations of Breztri Aerosphere (budesonide 160 mcg, glycopyrrolate 9 mcg,and formoterol fumarate 4.8 mcg) twice daily (morning and evening)

Dose of Breztri for Asthma Maintenance Treatment

• 2 inhalations of Breztri Aerosphere (budesonide 160 mcg, glycopyrrolate 18 mcg,and formoterol fumarate 4.8 mcg) twice daily (morning and evening)

What to Do if You Miss a Breztri Dose

If a dose (2 puffs) of Breztri is missed, it should be taken as soon as possible, and the next dose should be taken at the usual time. Do not take more than one dose to make up for a forgotten dose.

What to Do if You Take Too Much Breztri

If you take too much Breztri, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Breztri and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take:

• Anticholinergics (including tiotropium, ipratropium, aclidinium, and umeclidinium)
• Other LABAs (including salmeterol, formoterol fumarate, arformoterol tartrate, vilanterol, olodaterol, and indacaterol)
• Atropine
• Antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

• Store Breztri at room temperature between 68ºF and 77ºF (20ºC and 25ºC). Keep in a dry place away from heat and sunlight.
• Store Breztri in the unopened foil pouch and only open when ready for use.
• Do not put a hole in the Breztri canister.
• Do not use or store Breztri near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.
• Do not throw the Breztri canister into a fire or an incinerator.
• Throw away Breztri 3 months after you open the foil pouch (for the 120-inhalation canister), or 3 weeks after you open the foil pouch (for the 28-inhalation canister), or when the puff indicator reaches zero “0”, whichever comes first.

Keep out of reach of children and pets.

Active ingredients: micronized budesonide, micronized glycopyrrolate, and micronized formoterol fumarateInactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)

Breztri is manufactured for AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, by AstraZeneca Dunkerque Production (AZDP), Dunkerque, France.