Breztri
Pronunciation: brez-TREE
Generic name: budesonide, glycopyrrolate, and formoterol fumarate
Brand name: Breztri Aerosphere
Dosage form: inhalation aerosol, for oral inhalation
Drug class: Bronchodilator combinations
What is Breztri?
Breztri combines 3 medicines, an inhaled corticosteroid (ICS) medicine (budesonide), an anticholinergic medicine (glycopyrrolate), and a long-acting beta2-adrenergic agonist (LABA) medicine (formoterol fumarate) in 1 inhaler which may be used as long-term treatment for adults with chronic obstructive pulmonary disease (COPD).
- COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
Each of the 3 ingredients in Breztri has a different mechanism of action. Budesonide helps to decrease inflammation in the lungs which can lead to breathing problems. Glycopyrrolate blocks the effects of acetylcholine (a neurotransmitter) in the lungs, which allows the airways to relax and widen, making breathing easier. Formoterol binds to and activates beta2-adrenergic receptors on the smooth muscle cells in the airways. This activation also allows the airways to relax and widen, making breathing easier. Formoterol has a long-lasting effect, typically lasting 12 hours or more, which provides sustained symptom relief throughout the day for COPD patients.
Breztri is not for asthma because clinical trials have not been done in people with asthma (see Why is Breztri not for asthma?). Breztri is only approved for adults with COPD.
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 for you.
Breztri gained FDA approval on July 23, 2020, for adults with COPD.
Breztri 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 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 (palpitations).
Tell your healthcare provider about any side effect that bothers you or that does not go away.
Serious side effects and warnings
Breztri Aerosphere can cause the following serious side effects.
Fungal infections in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using your Breztri inhaler to help reduce your chance of getting thrush.
Pneumonia. People with COPD have a higher chance of getting pneumonia. Breztri Aerosphere may increase your chance of getting 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.
A weakened immune system and an increased chance of getting infections (immunosuppression). Breztri may make it harder for your immune system to fight infections.
Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where 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 Aerosphere). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD 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 using your Breztri inhaler, stop using it and call your healthcare provider right away.
Serious allergic reactions. 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.
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.
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 thinning or weakness.
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 may 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, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) have been reported after using a Breztri inhaler. Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm.
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 FDA at 1-800- FDA-1088. You may also report side effects to AstraZeneca at 1-800-236-9933.
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Before taking
Breztri Aerosphere should not be used in children because clinical trials have not been conducted in children and it is not known if this medicine is safe and effective in this age group.
Do not use Breztri Aerosphere if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the other ingredients in your Breztri inhaler. See "What are the ingredients in Breztri Aerosphere?" at the end of this page for a complete list of ingredients.
Before using Breztri Aerosphere, 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 Aerosphere may make these problems worse
- have a viral, bacterial, parasitic, or fungal infection
- are exposed to chickenpox or measles
- are pregnant or plan to become pregnant. It is not known if Breztri Aerosphere may harm your unborn baby
- are 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.
How should I use Breztri Aerosphere?
Breztri Aerosphere is used as 2 inhalations, 2 times each day (2 puffs in the morning and 2 puffs in the evening) to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Read the step-by-step instructions that come with your prescription or contact the Breztri Patient Assistance program.
- Before using Breztri Aerosphere, make sure your healthcare provider has taught you how to use the inhaler and that you understand how to use it correctly.
- Use this medicine exactly as your healthcare provider tells you to use it. Do not use it more often than prescribed.
- Use 2 inhalations of Breztri Aerosphere, 2 times each day (2 puffs in the morning and 2 puffs in the evening).
- Do not take more than 2 inhalations of Breztri Aerosphere 2 times each day.
- If a dose (2 puffs) 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.
- Rinse your mouth with water and spit the water out after each dose (2 puffs). Do not swallow the water. This will help to reduce the chance of getting a fungus infection (thrush) in the mouth and throat.
- If you take too much Breztri Aerosphere, 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.
- Do not spray Breztri Aerosphere in your eyes. If Breztri Aerosphere gets 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 Aerosphere does not relieve sudden breathing problems and you should not take extra doses 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.
- 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.
What other drugs will affect Breztri?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Breztri Aerosphere 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.
Breztri should not be used with other combination inhalers, such as Trelegy (see What is the difference between Breztri vs Trelegy?). Breztri may be used with rescue inhalers, such as albuterol.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
Breztri Aerosphere storage
Store Breztri Aerosphere at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep in a dry place away from heat and sunlight. Keep the Breztri inhaler in its unopened foil pouch and only open when ready to use.
Do not use or store Breztri Aerosphere near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.
Do not throw the canister into a fire or an incinerator. Do not put a hole in the canister.
Throw away the Breztri inhaler 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 dose indicator reaches zero “0”, whichever comes first.
Keep Breztri Aerosphere and all medicines out of the reach of children.
What are the ingredients in Breztri Aerosphere?
Active ingredients: budesonide, glycopyrrolate, and formoterol fumarate
Inactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)
Who makes Breztri?
Breztri Aerosphere is made by AstraZeneca, headquartered in Cambridge, UK.
Notable medications in AstraZeneca's portfolio include:
- Symbicort (asthma/COPD)
- Tagrisso (lung cancer)
- Farxiga (diabetes)
- Crestor (cholesterol)
- Nexium (acid reflux)
- Calquence (blood cancer)
- Imfinzi (cancer)
- Pulmicort (asthma)
- Fasenra (asthma).
Popular FAQ
How to use Breztri Aerosphere inhaler for asthma?
Breztri Aerosphere inhaler is not used for the treatment of asthma or for relief of bronchospasm. It is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Breztri Aerosphere is approved by the FDA for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is not known if Breztri is safe and effective in people with asthma.
What is the difference between Breztri vs Trelegy?
Trelegy and Breztri are both triple-combination inhalers, but they're approved for different uses. Trelegy can be used for both COPD and asthma in adults, while Breztri is only for COPD. Continue reading
Why is Breztri not for asthma?
Breztri is not for asthma because it was made specifically to help people with COPD, which is a different lung condition. When scientists tested Breztri, they only looked at how well it worked for COPD, not asthma. Even though asthma and COPD both affect breathing, they need different kinds of treatments. The mix of medicines in Breztri has been shown to work for COPD, but it might not be the best choice for controlling asthma symptoms. That's why doctors don't prescribe Breztri for asthma - they have other medicines that work better for people with asthma. Continue reading
How long does it take for Breztri to work?
Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol) works within about 5 minutes to improve lung function and help you breathe easier. However, it can take up to 4 weeks to see the full effects of this medication. Continue reading
How many puffs are in Breztri Aerosphere inhaler?
Breztri Aerosphere aerosol inhaler contains either 120 or 28 inhalations. This depends on the size of your inhaler. The canister has an attached dose counter that shows how many puffs are remaining. Continue reading
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