WARNINGS
Do not use BREZTRI AEROSPHERE if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the ingredients in BREZTRI AEROSPHERE. See “What are the ingredients in BREZTRI AEROSPHERE?” at the end of this Patient Information leaflet below for a complete list of ingredients in BREZTRI AEROSPHERE.
USES
What is BREZTRI AEROSPHERE?
BREZTRI AEROSPHERE 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, delivered as a propelled spray.
ICS medicines such as budesonide help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
Anticholinergic medicines, such as glycopyrrolate and LABA medicines, such as formoterol fumarate help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
BREZTRI AEROSPHERE is a prescription medicine used long term to treat people with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
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).
BREZTRI AEROSPHERE is not for the treatment of asthma. It is not known if BREZTRI AEROSPHERE is safe and effective in people with asthma. BREZTRI AEROSPHERE contains formoterol fumarate. LABA medicines such as formoterol fumarate when used alone increase the risk of hospitalizations and death from asthma problems. BREZTRI AEROSPHERE contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a 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 (an inhaled, short-acting bronchodilator) 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 AEROSPHERE should not be used in children. It is not known if BREZTRI AEROSPHERE is safe and effective in children.
HOW TO USE
How to use Breztri Aerosphere
Read the step-by-step instructions for using BREZTRI AEROSPHERE in the ‘Instructions for Use’ provided with this Patient Information leaflet.
Before using BREZTRI AEROSPHERE, make sure your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Use BREZTRI AEROSPHERE exactly as your healthcare provider tells you to use it. Do not use BREZTRI AEROSPHERE 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) of BREZTRI AEROSPHERE 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) of BREZTRI AEROSPHERE. 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.
What are the possible side effects of BREZTRI AEROSPHERE?
BREZTRI AEROSPHERE can cause serious side effects, including:
fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREZTRI AEROSPHERE 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
weakened immune system and increased chance of getting infections (immunosuppression).
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 inhaling your medicine, stop taking BREZTRI AEROSPHERE 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:
rash
hives
swelling of your face, mouth, and tongue
breathing problems
effects on your heart.
increased blood pressure
a fast or irregular heartbeat
chest pain
effects on your nervous system.
tremor
nervousness
bone thinning or weakness (osteoporosis).
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). Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm.
Common side effects of BREZTRI AEROSPHERE include
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.
These are not all the possible side effects of BREZTRI AEROSPHERE. 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.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BREZTRI AEROSPHERE for a condition for which it was not prescribed. Do not give your BREZTRI AEROSPHERE to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about BREZTRI AEROSPHERE that is written for healthcare professionals.
What are the ingredients in BREZTRI AEROSPHERE?
Active ingredients: micronized budesonide, micronized glycopyrrolate, and micronized formoterol fumarate.
Inactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)
OVERDOSE
No cases of overdose have been reported with BREZTRI AEROSPHERE.
BREZTRI AEROSPHERE contains budesonide, glycopyrrolate, and formoterol fumarate; therefore, the risks associated with overdosage for the individual components described below apply to BREZTRI AEROSPHERE. Treatment of overdosage consists of discontinuation of BREZTRI AEROSPHERE together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in case of overdosage.
Budesonide
If used at excessive doses for prolonged periods, systemic corticosteroid effects, such as hypercorticism may occur [see Warnings and Precautions (5.8)].
Glycopyrrolate
High doses of glycopyrrolate, a component of BREZTRI AEROSPHERE, may lead
to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision
disturbances or reddening of the eye), obstipation, or difficulties in voiding.
Formoterol Fumarate
An overdose of formoterol fumarate would likely lead to an exaggeration of effects that are typical for beta2-agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic medications, cardiac arrest, and even death may be associated with overdosage of formoterol fumarate.
MISSED DOSE
If a dose (2 puffs) of BREZTRI AEROSPHERE 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.
STORAGE
How should I store BREZTRI AEROSPHERE?
Store BREZTRI AEROSPHERE at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C). Keep in a dry place away from heat and sunlight.
Store BREZTRI AEROSPHERE in the unopened foil pouch and only open when ready for use.
Do not put a hole in the BREZTRI AEROSPHERE canister.
Do not use or store BREZTRI AEROSPHERE near heat or a flame. Temperatures above 120-degrees F (49-degrees C) may cause the canister to burst.
Do not throw the BREZTRI AEROSPHERE canister into a fire or an incinerator.
Throw away BREZTRI AEROSPHERE 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 BREZTRI AEROSPHERE and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 01/2022
Prescribing Information: revision date 01/2022
No formal drug interaction studies have been performed with BREZTRI AEROSPHERE.
1.) Inhibitors of Cytochrome P450 3A4
The main route of metabolism of corticosteroids, including budesonide, a component of BREZTRI AEROSPHERE, is via cytochrome P450 isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of BREZTRI AEROSPHERE with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin).
2.) Adrenergic Drugs
If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol, a component of BREZTRI AEROSPHERE, may be potentiated.
3.) Xanthine Derivatives, Steroids, or Diuretics
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate the hypokalemic effect of beta2-adrenergic agonists such as formoterol, a component of BREZTRI AEROSPHERE.
4.) Non-Potassium Sparing Diuretics
The hypokalemia and/or ECG changes that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta2-agonists, especially when the recommended dose of the beta2-agonist is exceeded.
5.) Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs
BREZTRI AEROSPHERE, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval may be associated with an increased risk of ventricular arrhythmias.
6.) Beta-adrenergic Receptor Blocking Agents
Beta-adrenergic receptor antagonists (beta-blockers) and BREZTRI AEROSPHERE may interfere with the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta2 -agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
7.) Anticholinergics
There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of BREZTRI AEROSPHERE with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
WARNINGS
Do not use BREZTRI AEROSPHERE if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the ingredients in BREZTRI AEROSPHERE. See “What are the ingredients in BREZTRI AEROSPHERE?” at the end of this Patient Information leaflet below for a complete list of ingredients in BREZTRI AEROSPHERE.
USES
What is BREZTRI AEROSPHERE?
BREZTRI AEROSPHERE 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, delivered as a propelled spray.
ICS medicines such as budesonide help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
Anticholinergic medicines, such as glycopyrrolate and LABA medicines, such as formoterol fumarate help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
BREZTRI AEROSPHERE is a prescription medicine used long term to treat people with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
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).
BREZTRI AEROSPHERE is not for the treatment of asthma. It is not known if BREZTRI AEROSPHERE is safe and effective in people with asthma. BREZTRI AEROSPHERE contains formoterol fumarate. LABA medicines such as formoterol fumarate when used alone increase the risk of hospitalizations and death from asthma problems. BREZTRI AEROSPHERE contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a 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 (an inhaled, short-acting bronchodilator) 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 AEROSPHERE should not be used in children. It is not known if BREZTRI AEROSPHERE is safe and effective in children.
HOW TO USE
How to use Breztri Aerosphere
Read the step-by-step instructions for using BREZTRI AEROSPHERE in the ‘Instructions for Use’ provided with this Patient Information leaflet.
Before using BREZTRI AEROSPHERE, make sure your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Use BREZTRI AEROSPHERE exactly as your healthcare provider tells you to use it. Do not use BREZTRI AEROSPHERE 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) of BREZTRI AEROSPHERE 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) of BREZTRI AEROSPHERE. 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.
