Uses
What is Breztri Aerosphere used for?
Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is commonly used for chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis.
Learn more about Breztri Aerosphere for COPD.
Breztri Aerosphere may also be used for other conditions as determined by your healthcare provider.
How does Breztri Aerosphere work (mechanism of action)?
Breztri Aerosphere is an inhaler that contains three different medicines in one inhaler. The medicines reduce swelling in the lungs and relax the muscles around the airways, making it easier to breathe. Breztri Aerosphere may reduce your COPD symptoms and help prevent COPD flare-ups (also known as exacerbations).
How is Breztri Aerosphere supplied (dosage forms)?
Breztri Aerosphere is available in the following dosage forms that are inhaled by mouth.
- 160 mcg/9 mcg/4.8 mcg per inhalation (Aerosphere inhaler)
How should I store Breztri Aerosphere?
Breztri Aerosphere should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place away from heat and sunlight.
Side Effects
What are the most common side effects of Breztri Aerosphere?
The most common side effects of Breztri Aerosphere are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Infections, including infections in the nose or throat, sore throat, common cold symptoms, or the flu (see below)
- Pneumonia (see below)
- Fungal infection of the mouth or throat, also called oral thrush (see below)
- Pain and frequent peeing (signs of a urinary tract infection)
- Back or joint pain
- Muscle spasms
- Cough or hoarseness
- Nausea or diarrhea
- Headache
- Increased blood sugar levels (see below)
- Sleeping problems
- Feeling anxious, tremor, or nervousness
- Feeling of skipped heartbeats, also called palpitations
There may be other side effects of Breztri Aerosphere that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Breztri Aerosphere?
While less common, the most serious side effects of Breztri Aerosphere are described below, along with what to do if they happen.
Severe Allergic Reactions. Breztri Aerosphere may cause allergic reactions, which can be serious. Stop using Breztri Aerosphere and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Reduced Adrenal Function. Long-term use of Breztri Aerosphere can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. This is especially a concern if you have been taking a corticosteroid by mouth, such as prednisone, and you stop it and switch to Breztri Aerosphere. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.
- Nausea and vomiting
- Weakness, tiredness, or lack of energy
- Low blood pressure
Pneumonia. Pneumonia is an infection of the lungs that can make it hard to breathe. Some people with COPD who use Breztri Aerosphere have developed pneumonia. Contact your healthcare provider right away if you have any of the following symptoms of pneumonia.
- Trouble breathing
- Increased mucus or change in mucus color
- Worsening cough
- Fever or chills
Infection. Breztri Aerosphere can increase the risk of infections, including serious infections. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick. Call your healthcare provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
Sudden Breathing Problems. Breztri Aerosphere may cause the muscles around the airways to tighten (bronchospasm) instead of relaxing, which can be serious. Stop using Breztri Aerosphere and contact your healthcare provider right away if your ability to breathe worsens right after using the medicine.
Oral Thrush. Breztri Aerosphere can sometimes cause the mouth and throat to become infected with a type of yeast, a condition known as oral thrush or oral candidiasis. Contact your healthcare provider if you notice any of the following symptoms of oral thrush.
- Cracking in the corners of the mouth
- Loss of taste
- Red or white patches in the mouth or throat
- Raised white spots in the mouth or throat
Heart Effects. Breztri Aerosphere may increase your risk of certain effects on the heart, such as raising your heart rate, blood pressure, or causing an abnormal heart rhythm (arrhythmia). If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Also call your healthcare provider or get medical attention right away if you have chest pain, a fast or irregular heartbeat, or if you feel your heartbeat more than usual.
Weak Bones. Using Breztri Aerosphere for a long time may cause the bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause bones to break (fracture) more easily. Tell your healthcare provider if you break a bone, and get a bone mineral density test if one is ordered for you.
Eye Problems. Breztri Aerosphere may increase the risk of cataracts or glaucoma (increased pressure inside the eye), which can lead to blindness. Tell your healthcare provider right away if you have any of the following symptoms of glaucoma or cataracts.
- Blurry or foggy vision
- Problems driving at night or with glares during the day
- Seeing double
- Loss of vision
- Eye pain or redness
- Severe headache or vomiting
- Seeing bright, colorful circles around lights (vision halos)
Inability to Empty Bladder (Urinary Retention). Breztri Aerosphere might make it harder to empty your bladder. Stop using Breztri Aerosphere and call your healthcare provider right away if you have a hard time peeing or have a weak stream, if peeing is painful, or you are peeing frequently.
Increased Blood Sugar. Breztri Aerosphere may increase your blood sugar levels. Talk to your healthcare provider about how to maintain healthy blood sugar levels.
Nervous System Effects. Breztri Aerosphere may cause nervous system effects, including tremor or nervousness. Contact your healthcare provider right away if you develop these symptoms.
Low Potassium Level (Hypokalemia). Breztri Aerosphere can cause a low potassium level, which can be serious. Your healthcare provider will check your potassium levels, especially if you take certain other medicines. Call your healthcare provider if you have any of the following symptoms of a low potassium level.
- Weakness
- Unusual tiredness
- Muscle cramps or twitching
- Constipation
Warnings & Precautions
Who should not use Breztri Aerosphere?
Allergies to Ingredients. People who are allergic to any of the following should not use Breztri Aerosphere.
- Breztri Aerosphere
- Budesonide
- Formoterol fumarate
- Glycopyrrolate
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Breztri Aerosphere.
What should I know about Breztri Aerosphere before using it?
Do not use Breztri Aerosphere unless it has been prescribed to you by a healthcare provider. Use it as prescribed. Using Breztri Aerosphere more often than prescribed may increase the risk of serious side effects.
Do not share Breztri Aerosphere with other people, even if they have the same condition as you. It may harm them.
Keep Breztri Aerosphere out of the reach of children.
Follow the instructions when using Breztri Aerosphere for the first time or when you have not used it for more than 7 days. The medicine needs to be primed so that you get the right dose.
Breztri Aerosphere is a medicine that is used on a regular basis and is not to be used when a quick response to breathing problems is needed.
After each dose (2 puffs) of Breztri Aerosphere, rinse your mouth with water and spit it out (do not swallow). This will help lower your risk of getting a fungal infection in your mouth and throat.
Avoid getting Breztri Aerosphere in your eyes. If Breztri Aerosphere gets in your eyes, rinse them well with water. Call your healthcare provider right away if you get Breztri Aerosphere in your eyes and you have eye pain or irritation.
Do not puncture the inhaler or store near heat or open flames. Never throw the inhaler away in a fire or incinerator.
Talk to your healthcare provider before stopping Breztri Aerosphere. If you stop, your COPD symptoms may get worse.
What should I tell my healthcare provider before using Breztri Aerosphere?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Breztri Aerosphere is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Heart problems or high blood pressure
- Seizures
- Problems with your thyroid, kidneys, or liver
- Weak or thin bones, such as osteopenia or osteoporosis
- Eye problems, such as glaucoma or cataracts
- Diabetes
- An infection, a history of immune problems or severe infections, or if you have been exposed to chickenpox or measles
- Problems with your bladder or prostate
Pregnancy. It is not known if or how Breztri Aerosphere could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. It is not known if Breztri Aerosphere passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Breztri Aerosphere while breastfeeding.
Other Medicines and Supplements. Breztri Aerosphere may interact with other medicines and supplements. Before using Breztri Aerosphere, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
How can I get more information about Breztri Aerosphere?
For more information about Breztri Aerosphere, you can visit the manufacturer’s website at www.breztri.com or call them at 833-458-0440.
Interactions
Does Breztri Aerosphere interact with foods or drinks?
There are no known interactions between Breztri Aerosphere and foods or drinks.
It is unknown if drinking alcohol will affect Breztri Aerosphere.
Does Breztri Aerosphere interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure you discuss if you are using any of the following before using Breztri Aerosphere.
- A beta-blocker, such as metoprolol (Lopressor), atenolol (Tenormin), or propranolol (Inderal LA), which is a medicine that may be used for certain heart conditions or to reduce blood pressure
- A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
- A long-acting beta-2 agonist (LABA), such as salmeterol (Serevent), formoterol (Perforomist), arformoterol (Brovana), or olodaterol (Striverdi), which is an inhaled medicine used for asthma or COPD
- A medicine for HIV or AIDS
- A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
- A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
- Medicines that can cause QT prolongation, which is a dangerous heart rhythm problem
- An anticholinergic medicine, which includes atropine, antihistamines, and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems. Some anticholinergic medicines are inhaled, such as tiotropium (Spiriva), umeclidinium (Incruse), ipratropium (Atrovent), and aclidinium (Tudorza)
- Clarithromycin, which is a medicine used for bacterial infections
- An antifungal medicine, such as ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend)
Some other medicines may alter the blood levels of Breztri Aerosphere. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Breztri Aerosphere. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Breztri Aerosphere?
If you or someone else has used too much Breztri Aerosphere, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Breztri Aerosphere?
If you miss a dose (2 puffs), use it as soon as you remember. Then, use your next dose at the regularly scheduled time. Do not take double or extra doses.