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BREZTRI AEROSPHERE is a brand name for Budesonide, supplied as a aerosol, metered dose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BREZTRI™ AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate dihydrate) is a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term maintenance treatment to reduce exacerbations of chronic…
Verbatim from this product's HC label. Tap a section to expand.
, chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. As with other inhaled drugs containing beta2-adrenergic agents, BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate dihydrate) should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA or LAMA, as an overdose may result.
When beginning treatment with BREZTRI AEROSPHERE, patients who have been taking rapid onset, short duration, inhaled beta2-agonists on a regular basis should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they BREZTRI™ AEROSPHERE® Product Monograph Page 5 of 50 develop acute respiratory symptoms while taking BREZTRI AEROSPHERE.
BREZTRI AEROSPHERE should not be used to treat acute symptoms of COPD. Patients should be prescribed a rapid onset, short duration inhaled bronchodilator to relieve the acute symptoms such as shortness of breath and advised to have this available for use at all times.
Patients should be made aware that for optimum benefit, BREZTRI AEROSPHERE must be used regularly, even when asymptomatic. 4 mcg glycopyrronium (as bromide) / 10 mcg formoterol fumarate dihydrate twice daily, administered as 2 inhalations in the morning and 2 inhalations in the evening.
Pediatrics (< 18 years of age):
BREZTRI AEROSPHERE should not be used in patients under 18 years of age.
Geriatrics (≥ 65 years of age):
No dosage adjustment is required in patients 65 years of age and older.
Renal Impairment:
No dosage adjustment is necessary for patients with renal impairment. However, because glycopyrronium is primarily eliminated via renal metabolism, for patients with severe renal impairment (creatine clearance of ≤30 mL/min) or end -stage renal disease requiring dialysis, BREZTRI AEROSPHERE should only be used if the expected benefit outweighs the potential risk and patients should be closely monitored.
Hepatic Impairment:
). Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections can overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD receiving inhaled corticosteroid-containing drugs include current smokers, patients with a history of prior pneumonia, patients with low body mass index and patients with severe COPD.
These factors should be considered when BREZTRI AEROSPHERE is prescribed, and treatment should be re-evaluated if pneumonia occurs. Sensitivity/Resistance As with all medications, immediate hypersensitivity reactions may occur after administration of BREZTRI AEROSPHERE.
If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria or skin rash) occur, therapy with BREZTRI AEROSPHERE should be stopped at once and alternative treatments should be considered.
The patient should NOT be re-challenged with BREZTRI AEROSPHERE if this is identified as the cause of the hypersensitivity reaction (see 2 CONTRAINDICATIONS). 1 Pregnant Women There are no adequate data on the use of BREZTRI AEROSPHERE in pregnant women.
Data on the use of inhaled budesonide in more than 2500 exposed pregnancies indicate no increased teratogenic risk associated with budesonide. Single-dose studies in humans found that very small amounts of glycopyrronium passed the placental barrier.
There are no adequate data from use of formoterol or glycopyrronium in pregnant women. No animal reproductive toxicology studies have been conducted with BREZTRI AEROSPHERE. Budesonide has been shown to induce embryofoetal toxicity in rats and rabbits, a class effect of glucocorticoids.
At very high doses/systemic exposure levels, formoterol caused implantation losses as well as decreases in birth weight and early postnatal survival, whereas glycopyrrolate had no significant effects on reproduction (see 16 NON-CLINICAL TOXICOLOGY).
General Not for use in asthma The safety and efficacy of BREZTRI AEROSPHERE in patients with asthma have not been evaluated. BREZTRI AEROSPHERE is not indicated for the treatment of asthma. Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of long-acting beta2-agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death (see Salmeterol Multicenter Asthma Research Trial).
Available data from controlled clinical trials also suggest that the 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 LABA are 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 (see Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta2-adrenergic Agonist Combination Products).
Available data do not suggest an increased risk of death with use of LABA in patients with COPD. Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta2-adrenergic Agonist Combination Products Four (4) large, 26-week, randomized, double-blind, active-controlled clinical safety trials were conducted to evaluate the risk of serious asthma-related events when LABA were used in fixed- dose combination with ICS compared with ICS alone in subjects with asthma.
Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared budesonide/formoterol with budesonide, 1 trial compared fluticasone propionate/salmeterol with fluticasone propionate, and 1 trial compared mometasone furoate/formoterol with mometasone furoate.
The fourth trial included pediatric subjects aged 4 to 11 years and compared fluticasone propionate/salmeterol with fluticasone propionate. The primary safety endpoint for all 4 trials was serious asthma-related events (hospitalizations, intubations, death).
BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate dihydrate) is contraindicated in patients who are hypersensitive to this drug or to any ingredient (s) in the formulation, including any non-medicinal ingredient(s), or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No dosage adjustment is necessary for patients with hepatic impairment. However because both budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver impairment, and patients with hepatic disease should be closely monitored.
4 Administration BREZTRI AEROSPHERE is for oral inhalation only. BREZTRI AEROSPHERE should be administered as 2 inhalations twice daily, in the morning and in the evening. To ensure proper administration of BREZTRI AEROSPHERE patients should be instructed how to administer the product correctly and advised to read the instructions for use carefully (see INSTRUCTIONS FOR USE).
5 Missed Dose If a dose is missed, it should be taken as soon as possible, and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose. BREZTRI™ AEROSPHERE® Product Monograph Page 6 of 50
BREZTRI AEROSPHERE should only be used during pregnancy if the expected benefits outweigh the potential risks. 2 Breast-feeding A clinical pharmacology study has shown that inhaled budesonide is excreted in breast milk. However, budesonide was not detected in nursing infant blood samples.
17% of the mother’s plasma concentration. Consequently, no effects due to budesonide are anticipated in breast-fed children whose mothers are receiving therapeutic doses of BREZTRI AEROSPHERE. It is not known whether glycopyrronium or formoterol are excreted in human milk.
Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported. Administration of BREZTRI AEROSPHERE to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
3 Pediatrics BREZTRI AEROSPHERE is not indicated in the pediatric population as the safety and efficacy of BREZTRI AEROSPHERE has not been evaluated in patients less than 18 years of age. 4 Geriatrics No dosage adjustment is required in patients 65 years of age and older , however greater sensitivity in some older individuals cannot be ruled out.
1 Adverse Reaction Overview The overall safety profile of BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate dihydrate) was generally consistent with the known pharmacologic class effects of ICSs, LAMAs and/or LABAs.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. As BREZTRI AEROSPHERE contains budesonide, glycopyrronium and formoterol fumarate dihydrate, the type and severity of adverse reactions associated with each of the components may be expected with BREZTRI AEROSPHERE.
2/5 mcg per delivered actuation included 2144 subjects with COPD in one 52-week clinical trial (PT010005), and 639 subjects with COPD in one 24-week clinical trial (PT010006). Adverse drug reactions that occurred at a frequency of ≥1% are listed by MedDRA system organ class.
5) Skin and subcutaneous […]
A single, blinded, independent, joint adjudication committee determined whether events were asthma related. 7 -fold increase in this relative risk. Each individual trial met its pre-specified objective and demonstrated non- inferiority of ICS/LABA to ICS alone.
A meta-analysis of the 3 adult and adolescent trials did not show a significant increase in risk of a serious asthma-related event with ICS/LABA fixed-dose combination compared with ICS alone (Table 2). These trials were not designed to rule out all risk for serious asthma-related events with ICS/LABA compared with ICS.
BREZTRI™ AEROSPHERE® Product Monograph Page 8 of 50 Table 2 – Meta-analysis of serious asthma-related events in subjects with asthma aged 12 years and older ICS = Inhaled corticosteroid; LABA = Long-acting beta2-adrenergic agonist.
a Randomized subjects who had taken at least 1 dose of study drug. Planned treatment used f or analysis. b Estimated using a Cox proportional hazards model for time to first event with baseline hazards stratif ied by each of the 3 trials.
c Number of subjects with an event that occurred within 6 months after the first use of study drug or 7 days af ter the last date of study drug, whichever date was later. Subjects may have had one or more events, but only the f irst event was counted f or analysis.
A single, blinded, independent, joint adjudication committee determined whether events were asthma related. S. 34]). Use of background ICS was not required in the Salmeterol Multicenter Asthma Research Trial. The increased risk of asthma- related death is considered a class effect of LABA monotherapy.
Deterioration of disease BREZTRI AEROSPHERE should not be initiated in patients with acutely deteriorating COPD which may be a life-threatening condition. The use of BREZTRI AEROSPHERE in this setting has not been studied and is not considered appropriate.
COPD may deteriorate acutely over a period of hours or chronically over several days or longer . If BREZTRI AEROSPHERE no longer controls symptoms of bronchoconstriction, the patient’s inhaled, short-acting bronchodilator becomes less effective or the patient needs more inhalation of a short-acting bronchodilator than usual, these may be markers of deterioration of disease.
In this setting, a re-evaluation of the patient and the treatment regimen should be undertaken at once. Consideration should be given to the need for increased therapy such as a course of oral corticosteroids or antibiotic treatment if an infection is present.
Exacerbations may occur during treatment with BREZTRI AEROSPHERE. Patients should be advised to continue treatment and seek medical advice if symptoms remain uncontrolled or worsen after initiation of therapy with BREZTRI AEROSPHERE.
Patients should not stop therapy with BREZTRI AEROSPHERE without physician supervision since symptoms may recur after discontinuation. ICS/LABA (n=17,537)a ICS (n=17,552)a ICS/LABA vs. , as rescue […]