What Makes BREZTRI for COPD Different?

BREZTRI is a COPD maintenance treatment that combines 3 types of medicine into 1 inhaler to help you breathe better

BREZTRI AEROSPHERE is a medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

BREZTRI is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

An ICS (budesonide) helps decrease inflammation in the lungs that can lead to breathing problems.

LAMA (glycopyrrolate) and LABA (formoterol fumarate) are bronchodilators, that work by relaxing the muscles around the airways in your lungs. This makes it easier to breathe and relieve symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

ICS=inhaled corticosteroid; LABA=long-acting beta₂-adrenergic agonist; LAMA=long-acting muscarinic antagonist.

In clinical studies, lung function was shown to improve starting within 5 minutes* of taking BREZTRI

BREZTRI helped prevent moderate or severe flare-ups compared to LAMA/LABA and ICS/LABA

In clinical studies, BREZTRI was compared with 2 types of COPD medications:

LAMA/LABA

A dual bronchodilator.

ICS/LABA

A combination of an anti-inflammatory and bronchodilator.

In one study of people with COPD,^§ most of whom did not have a history of flare-ups in the last year

BREZTRI SHOWED A

FLARE-UP^II REDUCTION VS LAMA/LABA

AND

FLARE-UP^II REDUCTION VS ICS/LABA

The estimated rate of moderate or severe flare-ups per year were: BREZTRI 0.46; LAMA/LABA 0.95; ICS/LABA 0.56.

Based on the limitations of this study, results are descriptive and for information only. Your experience may differ.

In a second study of people with COPD,^§ all of whom had a history of flare-ups in the last year

BREZTRI SHOWED A

FLARE-UP^II REDUCTION VS LAMA/LABA

AND

FLARE-UP^II REDUCTION VS ICS/LABA

The estimated rates of moderate or severe flare-ups per year were: BREZTRI 1.08; LAMA/LABA 1.42; ICS/LABA 1.24.

^§Patients with COPD who were not required to have a moderate or severe flare-up in the previous year.

^IIA flare-up was considered moderate if it needed to be treated with steroid medicine (by mouth or injection) and/or antibiotics. A flare-up was considered severe if it resulted in hospitalization.

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FAQs About BREZTRI for COPD

BREZTRI is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD). BREZTRI is used long term 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).

To learn more, read the BREZTRI Patient Information.

*Result may vary.

^†BREZTRI is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

BREZTRI combines 3 different 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. In clinical studies, BREZTRI*:

Improved lung function starting within 5 minutes†
Helped prevent flare-ups^‡
Improved COPD symptoms

*Results may vary.

^†BREZTRI is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

^‡Compared to a dual bronchodilator and an anti-inflammatory and bronchodilator combination.

BREZTRI is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Do not use BREZTRI if you are allergic to budesonide, glycopyrrolate, formoterol fumarate, or any of the ingredients in BREZTRI.

To learn more, read additional Important Safety Information.

Get answers to more questions about BREZTRI

FAQs

Important Safety Information

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). LABA medicines, such as formoterol fumarate, when used alone can increase the risk of hospitalizations and death from asthma problems. When an ICS and LABA are used together, this risk is not significantly increased
Do not use BREZTRI to treat sudden severe symptoms of COPD or asthma, or if you are allergic to budesonide, glycopyrrolate, formoterol fumarate, or any of the ingredients in BREZTRI
Do not take BREZTRI with other medicines that contain a long-acting beta₂-adrenergic agonist (LABA) or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take
Do not use BREZTRI more than prescribed
Do not use in children younger than 12 years of age
Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well to relieve your symptoms
BREZTRI can cause serious side effects, including:
- Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREZTRI to help reduce your chance of getting thrush
- Pneumonia. People with COPD have a higher chance of getting pneumonia. Call your healthcare provider if you notice an increase in mucus (sputum) production or change in mucus color, fever, chills, increased cough, or increased breathing problems
- Weakened immune system and increased chance of getting infections (immunosuppression)
- Reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
- Sudden breathing problems immediately after inhaling BREZTRI. If this happens, stop taking BREZTRI 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: rash; hives; swelling of your face, mouth, and tongue; or breathing problems
- Effects on your heart such as increased blood pressure, a fast or irregular heartbeat, or chest pain
- Effects on your nervous system such as tremor or nervousness
- Bone thinning or weakness (osteoporosis)
- Slowed growth in children. A child’s growth should be checked regularly while using BREZTRI
- Acute narrow-angle glaucoma and cataracts. If you have new or worsening eye or vision problems, call your healthcare provider right away before taking another dose
- Urinary retention. If you have new or worsening symptoms or difficulty urinating, stop taking BREZTRI 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
Most common side effects include: upper respiratory tract infection, pneumonia, back pain, thrush in your mouth and throat, joint pain, flu, headache, high blood sugar levels, muscle spasms, cough, inflammation of the sinuses, diarrhea, hoarseness, urinary tract infection, nausea, difficulty sleeping, feeling anxious and heart palpitations

Approved Use

BREZTRI AEROSPHERE 160/9/4.8 mcg is used long term to treat chronic obstructive pulmonary disease (COPD) in adults, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

BREZTRI AEROSPHERE 160/18/4.8 mcg is used for the treatment of asthma in patients 12 years of age and older.

BREZTRI is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

Please see full Prescribing Information, including Patient Information and Instructions for Use, and discuss with your doctor.

You may report side effects related to AstraZeneca products.

What Makes BREZTRI for COPD Different?

BREZTRI is a COPD maintenance treatment that combines 3 types of medicine into 1 inhaler to help you breathe better

BREZTRI—a COPD inhaler that works as hard as you do