Breztri Aerosphere

Last updated on RxList: 1/22/2021
Breztri Aerosphere Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Breztri Aerosphere?

Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) is a combination of an inhaled corticosteroid, an anticholinergic, and a long-acting beta2-adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

What Are Side Effects of Breztri Aerosphere?

Side effects of Breztri Aerosphere include:

Dosage for Breztri Aerosphere

The dose of Breztri Aerosphere for maintenance treatment of COPD is 2 inhalations twice daily administered by oral inhalation.

Breztri Aerosphere In Children

Breztri Aerosphere is not indicated for use in children. The safety and effectiveness of Breztri Aerosphere have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Breztri Aerosphere?

Breztri Aerosphere may interact with other medicines such as:

  • strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, ketoconazole, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin),
  • other adrenergic drugs,
  • diuretics,
  • xanthine derivatives,
  • steroids,
  • monoamine oxidase inhibitors (MAOIs),
  • tricyclic antidepressants,
  • beta-blockers,
  • QTc prolonging drugs, and
  • anticholinergics

ell your doctor all medications and supplements you use.

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Breztri Aerosphere During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Breztri Aerosphere; it is unknown how it would affect a fetus. Budesonide passes into breast milk. There are no available data on the presence of glycopyrrolate or formoterol fumarate in breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol, for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Breztri Aerosphere Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsened breathing problems;
  • wheezing, choking, or other breathing problems after using this medication;
  • tremors, nervousness, chest pain, fast or pounding heartbeats;
  • sores or white patches in your mouth and throat, pain when swallowing;
  • flu symptoms, body aches, unusual tiredness;
  • painful or burning when you urinate, little or no urination;
  • blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
  • signs of a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath; or
  • signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Common side effects may include:

  • throat pain or irritation;
  • white patches in your mouth or throat;
  • headache, joint pain, muscle spasms;
  • pounding heartbeats, feeling anxious;
  • high blood sugar levels;
  • painful or difficult urination;
  • nausea, diarrhea;
  • cough, hoarse voice;
  • flu symptoms; or
  • cold symptoms such as stuffy or runny nose, sneezing, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Breztri Aerosphere (Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol)

SLIDESHOW

COPD Foods to Boost Your Health - COPD Diet Tips See Slideshow
Breztri Aerosphere Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling.

  • Serious asthma-related events - hospitalizations, intubations, death [see WARNINGS AND PRECAUTIONS]
  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Increased risk of pneumonia in COPD [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression and risk of infections [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
  • Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions including anaphylaxis [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • Cardiovascular effects [see WARNINGS AND PRECAUTIONS]
  • Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
  • Worsening of narrow-angle glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]
  • Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of BREZTRI AEROSPHERE is based on the safety data from one 52-week exacerbation trial (Trial 1) and one 24-week lung function trial with a 28-week safety extension study, resulting in up to 52 weeks of treatment (Trial 2). In Trials 1 and 2, a total of 2783 subjects have received at least 1 dose of BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg [see Clinical Studies].

In Trials 1 and 2, subjects received one of the following treatments: BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg, glycopyrrolate and formoterol fumarate [GFF MDI 18 mcg/9.6 mcg], or budesonide and formoterol fumarate [BFF MDI 320 mcg/9.6 mcg]. Each treatment was administered twice daily.

In Trial 1, a 52-week, randomized, double-blind clinical trial, a total of 2144 subjects with COPD received at least 1 dose of BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg (mean age: 64.7 years, 84.9% Caucasian, 59.7% male across all treatments) [see Clinical Studies].

In Trial 2, a 24-week, randomized, double-blind clinical trial, with a 28-week long-term safety extension resulting in up to 52 weeks of treatment, a total of 639 subjects received at least 1 dose of BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg (mean age: 65.2 years, 50.1% Caucasian, 71.2% male across all treatments) [see Clinical Studies].

The incidence of adverse reactions from the 52-week trial (Trial 1) is presented in Table 1 for subjects treated with BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg, GFF MDI 18 mcg/9.6 mcg, or BFF MDI 320 mcg/9.6 mcg.

Table 1: Adverse reactions occurring at an incidence of ≥ 2% of subjects and more common in BREZTRI AEROSPHERE compared to GFF MDI and BFF MDI (Trial 1)

Adverse ReactionBREZTRI AEROSPHERE1 320 mcg/18 mcg/9.6 mcg
N=2144 (%)
GFF MDI1 18 mcg/9.6 mcg
N=2125 (%)
BFF MDI1 320 mcg/9.6 mcg
N=2136 (%)
Upper Respiratory Tract Infection123 (5.7)102 (4.8)115 (5.4)
Pneumonia98 (4.6)61 (2.9)107 (5.0)
Back pain67 (3.1)55 (2.6)64 (3.0)
Oral candidiasis65 (3.0)24 (1.1)57 (2.7)
Influenza63 (2.9)42 (2.0)61 (2.9)
Muscle spasms60 (2.8)19 (0.9)53 (2.5)
Urinary tract infection58 (2.7)60 (2.8)41 (1.9)
Cough58 (2.7)50 (2.4)51 (2.4)
Sinusitis56 (2.6)47 (2.2)55 (2.6)
Diarrhea44 (2.1)37 (1.7)38 (1.8)
1 BREZTRI AEROSPHERE = budesonide/glycopyrrolate/formoterol fumarate 320 mcg/18 mcg/9.6 mcg; GFF MDI = glycopyrrolate/formoterol fumarate 18 mcg/9.6 mcg; BFF MDI = budesonide/formoterol fumarate 320 mcg/9.6 mcg; all treatments were administered twice daily.

In 24-week data from Trial 2, adverse reactions that occurred in subjects treated with BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg (n=639) at an incidence of ≥ 2% included dysphonia (3.3%) and muscle spasms (3.3%).

Additional Adverse Reactions

Other adverse reactions that have been associated with one or more of the individual components of BREZTRI AEROSPHERE include: hyperglycemia, anxiety, insomnia, headache, palpitations, nausea, hypersensitivity, depression, agitation, restlessness, nervousness, tremor, dizziness, angina pectoris, tachycardia, cardiac arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia, and extrasystoles), throat irritation, bronchospasm, dry mouth, bruising, urinary retention, chest pain, sign or symptoms of systemic glucocorticoid steroid effects (e.g., hypofunctional adrenal gland), and abnormal behavior.

Read the entire FDA prescribing information for Breztri Aerosphere (Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol)

© Breztri Aerosphere Patient Information is supplied by Cerner Multum, Inc. and Breztri Aerosphere Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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