Overview
11 DESCRIPTION BREZTRI AEROSPHERE (budesonide, glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of micronized budesonide [an inhaled corticosteroid (ICS)], micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate [an inhaled long-acting beta 2 -adrenergic agonist (a LABA)] for oral inhalation.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action BREZTRI AEROSPHERE BREZTRI AEROSPHERE contains budesonide, glycopyrrolate, and formoterol fumarate. The mechanism of action described below for the individual components applies to BREZTRI AEROSPHERE. These drugs represent three different classes of medications (a synthetic corticosteroid, an anticholinergic, and a long-acting selective beta 2 -adrenoceptor agonist) that have different effects on clinical physiology and inflammatory indices of COPD and asthma. Budesonide Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.
Indications
- 1 INDICATIONS AND USAGE BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1.1 ) • the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use: Not indicated for the relief of acute bronchospasm. ( 1.3 , 5.1 , 5.2 ) 1.
Common Doses
- 160 mcg
- 9 mcg
- 4.8 mcg
- 18 mcg
Dosage
2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2 ) • Prime BREZTRI AEROSPHERE before first time use and re-prime if not used for more than 7 days. ( 2.1 ) • Maintenance treatment of COPD: 2 inhalations of BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg twice daily administered by oral inhalation. ( 2.2 ) • Maintenance treatment of asthma: 2 inhalations of BREZTRI AEROSPHERE 160 mcg/18 mcg/4.8 mcg twice daily administered by oral inhalation. ( 2.3 ) 2.
Contraindications
- 4 CONTRAINDICATIONS BREZTRI AEROSPHERE is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions (5.2) ] . • Hypersensitivity to budesonide, glycopyrrolate, formoterol, or any of the excipients [see Warnings and Precautions (5.11) and Description (11) ] . • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures.
Side Effects
- 6 ADVERSE REACTIONS 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 (5.1) ] • Oropharyngeal candidiasis infection [see Warnings and Precautions (5.4) ] • Increased risk of pneumonia in COPD [see Warnings and Precautions (5.5) ] • Immunosuppression and risk of infections [see Warnings and Precautions (5.6) ] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8) ] • Paradoxical bronchospasm [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS No formal drug interaction studies have been performed with BREZTRI AEROSPHERE. • Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution. May cause systemic corticosteroid effects. ( 7.1 ) • Other adrenergic drugs may potentiate effect: Use with caution. ( 7.2 ) • Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes. Use with caution. ( 7.3 , 7.4 ) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system. ( 7.