BREZTRI

BREZTRI- budesonide, glycopyrrolate and formoterol aerosol, metered
AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE

BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Limitations of Use:

BREZTRI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage and Administration

The recommended dosage of BREZTRI AEROSPHERE is budesonide 320 mcg, glycopyrrolate 18 mcg and formoterol fumarate 9.6 mcg (administered as 2 inhalations of BREZTRI AEROSPHERE [budesonide/glycopyrrolate/formoterol fumarate 160 mcg/9 mcg/4.8 mcg]) twice daily in the morning and in the evening by oral inhalation. Do not take more than two inhalations twice daily.

After inhalation, rinse mouth with water without swallowing.

2.2 Preparation

Prime BREZTRI AEROSPHERE before using for the first time. Priming BREZTRI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BREZTRI AEROSPHERE by releasing 4 sprays into the air away from the face, shaking well before each spray.

If the inhaler has not been used for more than 7 days, is dropped, or after weekly cleaning, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well before each spray.

2.3 Dose counter

BREZTRI AEROSPHERE canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable inhalations, the color behind the number in the dose indicator display window changes to red. BREZTRI AEROSPHERE should be discarded when the dose indicator display window shows zero.

3 DOSAGE FORMS AND STRENGTHS

Inhalation Aerosol: a pressurized metered dose inhaler that delivers a combination of 160 mcg budesonide, 9 mcg glycopyrrolate, and 4.8 mcg formoterol fumarate per inhalation.

4 CONTRAINDICATIONS

BREZTRI AEROSPHERE is contraindicated in patients who have demonstrated hypersensitivity to budesonide, glycopyrrolate, formoterol, or any of the excipients [see Warnings and Precautions (5.11) and Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death

The safety and efficacy of BREZTRI AEROSPHERE in patients with asthma have not been established. BREZTRI AEROSPHERE is not indicated for the treatment of asthma.

Use of long-acting beta2 -adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroid (ICS)] for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When a LABA is used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.

Available data do not suggest an increased risk of death with use of LABA in patients with COPD.

5.2 Deterioration of Disease and Acute Episodes

BREZTRI AEROSPHERE should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. BREZTRI AEROSPHERE has not been studied in patients with acutely deteriorating COPD. The use of BREZTRI AEROSPHERE in this setting is not appropriate.

BREZTRI AEROSPHERE should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. BREZTRI AEROSPHERE has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta2 -agonist.

When beginning treatment with BREZTRI AEROSPHERE, patients who have been taking inhaled, short-acting beta2 -agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing BREZTRI AEROSPHERE, the healthcare provider should also prescribe an inhaled, short acting beta2 -agonist and instruct the patient on how it should be used. Increasing inhaled beta2 -agonist use is a signal of deteriorating disease for which prompt medical attention is indicated.

COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If BREZTRI AEROSPHERE no longer controls symptoms, or the patient’s inhaled, short-acting beta2 -agonist becomes less effective or the patient needs more inhalations of short-acting beta2 -agonist than usual, these may be markers of deterioration of disease. In this setting, re-evaluate the patient and the COPD treatment regimen at once. The daily dosage of BREZTRI AEROSPHERE should not be increased beyond the recommended dose.

5.3 Avoid Excessive Use of BREZTRI AEROSPHERE and Avoid Use with other Long-Acting Beta2 -Agonists

As with other inhaled drugs containing beta2 -adrenergic agents, BREZTRI AEROSPHERE should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using BREZTRI AEROSPHERE should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason [see Drug Interactions (7.1)].

5.4 Oropharyngeal Candidiasis

BREZTRI AEROSPHERE contains budesonide, an ICS. Localized infections of the mouth and pharynx with Candida albicans have occurred in subjects treated with orally inhaled drug products containing budesonide. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with BREZTRI AEROSPHERE continues. In some cases, therapy with BREZTRI AEROSPHERE may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following administration of BREZTRI AEROSPHERE to help reduce the risk of oropharyngeal candidiasis.

5.5 Pneumonia

Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.

In a 52-week trial of subjects with COPD (n = 8,529), the incidence of confirmed pneumonia was 4.2% for BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg (n = 2144), 3.5% for budesonide, glycopyrrolate and formoterol fumarate [BGF MDI 160 mcg/18 mcg/9.6 mcg] (n = 2124), 2.3% for GFF MDI 18 mcg/9.6 mcg (n = 2125) and 4.5% for BFF MDI 320 mcg/9.6 mcg (n = 2136).

Fatal cases of pneumonia occurred in 2 subjects receiving BGF MDI 160 mcg/18 mcg/9.6 mcg, 3 subjects receiving GFF MDI 18 mcg/9.6 mcg, and no subjects receiving BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg.

In a 24-week trial of subjects with COPD (n = 1,896), the incidence of confirmed pneumonia was 1.9% for BREZTRI AEROSPHERE 320 mcg/18 mcg/9.6 mcg (n = 639), 1.6% for glycopyrrolate and formoterol fumarate [GFF MDI 18 mcg/9.6 mcg] (n = 625) and 1.9% for budesonide and formoterol fumarate [BFF MDI 320 mcg/9.6 mcg] (n = 320). There were no fatal cases of pneumonia in the study.

5.6 Immunosuppression and Risk of Infections

Patients who are using drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered.

ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

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