Breztri Aerosphere

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Breztri Aerosphere Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Budesonide 160mcg, glycopyrrolate 9mcg, formoterol fumarate 4.8mcg; per inhalation; metered-dose inhaler with dose counter.

    Pharmacological Class

    Corticosteroid + anticholinergic + long-acting beta-2 agonist (LABA).

    How Supplied

    Inhalation aerosol—10.7g (120 inh)

    How Supplied

    Breztri Aerosphere Inhalation Aerosol:  

    • 160 mcg budesonide, 9.0 mcg glycopyrrolate, and 4.8 mcg formoterol fumarate per inhalation  

    • is supplied as a pressurized aluminum canister with an attached dose indicator, a white plastic actuator and mouthpiece, and a light grey dust cap.  

    • contains 28 or 120 inhalations per canister. 

    • each 120-inhalation canister has a net fill weight of 10.7 grams.  

    • each 28-inhalation canister (institutional pack) has a net fill weight of 5.9 grams.  

    • each canister of Breztri Aerosphere is packaged in a foil pouch with desiccant sachet and is placed into a carton.  

    • each carton contains one canister and Patient Information.

    Storage

    Breztri Aerosphere should be discarded when the dose indicator display window shows zero or 3 months (for the 120-inhalation canister) or 3 weeks (for the 28-inhalation canister) after removal from the foil pouch, whichever comes first.

    Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP]. Keep in a dry place away from heat and sunlight. For best results, the canister should be at room temperature before use. Shake well before using. Keep out of reach of children. 

    Do not use or store near heat or open flames. Exposure to temperatures above 120°F (49°C) may cause bursting. Never throw canister into fire or incinerator.

    Manufacturer

    AstraZeneca Pharmaceuticals

    Generic Availability

    NO

    Breztri Aerosphere Indications

    Indications

    Maintenance treatment of COPD.

    Limitations of Use

    Not indicated for relief of acute bronchospasm or for treatment of asthma.

    Breztri Aerosphere Dosage and Administration

    Adult

    2 inhalations twice daily (in the AM + PM). Max 2 inhalations twice daily. Rinse mouth after each use.

    Children

    Not established.

    Breztri Aerosphere Contraindications

    Not Applicable

    Breztri Aerosphere Boxed Warnings

    Not Applicable

    Breztri Aerosphere Warnings/Precautions

    Warnings/Precautions

    LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acutely deteriorating COPD. Not for relief of acute symptoms. Prescribe a short-acting inhaled β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin prophylaxis or antiviral ­treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress or a severe COPD exacerbation. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), IOP, glaucoma, or cataracts. Discontinue immediately and treat if paradoxical bronchospasms or hypersensitivity reactions occur; use alternative therapy. Cardiovascular disorders (eg, coronary insufficiency, cardiac arrhythmias, hypertension). Assess for bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Urinary retention. Narrow-angle glaucoma. Prostatic hyperplasia. Bladder-neck obstruction. Hyperresponsiveness to sympathomimetics. Convulsive disorders. Thyrotoxicosis. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Severe hepatic impairment: monitor. Severe renal impairment or ESRD requiring dialysis. Pregnancy. Labor & delivery. Nursing mothers.

    Warnings/Precautions

    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. 

    • 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. 

    Deterioration of Disease and Acute Episodes

    • Do not initiate in patients with acutely deteriorating COPD. 

    • Not for relief of acute symptoms (i.e. as rescue therapy to treat acute episodes of bronchospasm). Not studied in the relief of acute symptoms. Treat acute symptoms with an inhaled short-acting beta2-agonist. Prescribe an inhaled, short-acting beta2-agonist.

    • Prior to initiation, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g. four times a day) should discontinue the regular use of these and use them only for symptomatic relief of acute respiratory symptoms.

    • If symptoms are no longer controlled or if inhaled, short-acting beta2-agonist is less effective, then re-evaluate the patient and COPD treatment regimen. Do not exceed the recommended dose of Breztri Aerosphere.

    Avoid Excessive Use of Breztri Aerosphere and Avoid Use with other Long-Acting Beta2-Agonists

    • Do not use more often than recommended, at higher doses than recommended, or concomitantly with medications containing LABA.

    Oropharyngeal Candidiasis  

    • If localized infections of the mouth and pharynx with Candida albicans occur, treat appropriately with local or systemic (i.e., oral) antifungal therapy while treatment with Breztri Aerosphere continues.

    • Rinse mouth with water without swallowing following administration to help reduce the risk of oropharyngeal candidiasis.

    Pneumonia

    • Be alert for the risk of development of pneumonia in patients with COPD.

    Immunosuppression and Risk of Infections 

    • Increased risk of infection in patients taking drugs that suppress the immune system.

    • If 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, consider treatment with antiviral agents.

    • Use 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.

    Transferring Patients from Systemic Corticosteroid Therapy

    • HPA Suppression/Adrenal Insufficiency

      • Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.

      • During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss.

      • During periods of stress or a severe COPD exacerbation, instruct patients who have withdrawn from systemic corticosteroids to resume oral corticosteroids (in large doses) immediately.

      • Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Breztri Aerosphere. Carefully monitor patients during withdrawal of oral corticosteroids. Observe for signs and symptoms of adrenal insufficiency.

    • Unmasking of Allergic Conditions Previously Suppressed by Systemic Corticosteroids

      • Transfer from systemic corticosteroid therapy to Breztri Aerosphere may unmask allergic conditions previously suppressed.

    • Corticosteroid Withdrawal Symptoms

      • May experience symptoms of systemically active corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function. 

    Hypercorticism and Adrenal Suppression  

    • Exceeding the recommended dosage or coadministration with a strong CYP3A4 inhibitor may result in HPA dysfunction.

    • Observe carefully for any evidence of systemic corticosteroid effects, especially patients postoperatively or during periods of stress for evidence of inadequate adrenal response. 

    • May cause systemic corticosteroid effects, such as hypercorticism and adrenal suppression (including adrenal crisis), in a small number of patients. Initiate appropriate therapy if these effects occur as needed.

    Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

    • Use caution when considering the coadministration of Breztri Aerosphere with long-term ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) due to increased systemic exposure to budesonide.

    Paradoxical Bronchospasm

    • If paradoxical bronchospasm occurs after administration with Breztri Aerosphere, treat immediately with an inhaled, short-acting bronchodilator. Discontinue Breztri Aerosphere immediately and institute alternative therapy.

    Hypersensitivity Reactions including Anaphylaxis

    • Discontinue Breztri Aerosphere immediately and consider alternative therapy if signs suggesting allergic reactions occur, in particular, angioedema, urticaria, or skin rash.

    Cardiovascular Effects  

    • May produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. May need to discontinue if these effects occur.

    • Use caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 

    Reduction in Bone Mineral Density 

    • Monitor and treat with established standards of care in patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids).

    • Assess bone mineral density (BMD) prior to initiation and periodically thereafter.

    Glaucoma and Cataracts, Worsening of Narrow-Angle Glaucoma 

    • Use caution in patients with narrow-angle glaucoma.

    • Be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema).

    • Consider referral to an ophthalmologist in patients who develop ocular symptoms or use long term. 

    Worsening of Urinary Retention

    • Use caution in patients with urinary retention.

    • Be alert for signs and symptoms of prostatic hyperplasia or bladder-neck obstruction (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder neck obstruction. 

    Coexisting Conditions

    • Use caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines.

    Hypokalemia and Hyperglycemia  

    • May produce significant hypokalemia in some patients, possibly through intracellular shunting, and may produce transient hyperglycemia.

    Pregnancy Considerations

    Risk Summary 

    • There are no adequate and well-controlled studies with Breztri Aerosphere or with two of its individual components, glycopyrrolate or formoterol fumarate, in pregnant women to inform a drug-associated risk; however, studies are available for the other component, budesonide.  

    Clinical Considerations

    • Labor or Delivery:  Because of the potential for beta-agonist interference with uterine contractility, use of Breztri Aerosphere during labor should be restricted to those patients in whom the benefits clearly outweigh the risks.

    Nursing Mother Considerations

    Risk Summary

    • There are no available data on the effects of Breztri Aerosphere, budesonide, glycopyrrolate, or formoterol fumarate on the breastfed child or on milk production.

    • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Breztri Aerosphere and any potential adverse effects on the breast-fed child from Breztri Aerosphere or from the underlying maternal condition. 

    Pediatric Considerations

    The safety and effectiveness of Breztri Aerosphere have not been established in pediatric patients.

    Geriatric Considerations

    No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

    Renal Impairment Considerations

    Formal pharmacokinetic studies using Breztri Aerosphere have not been conducted in patients with renal impairment.

    Use only in patients with severe renal impairment (creatinine clearance of ≤30 mL/min/1.73 m2) or end-stage renal disease requiring dialysis if the expected benefit outweighs the potential risk.

    Hepatic Impairment Considerations

    Formal pharmacokinetic studies using Breztri Aerosphere have not been conducted in patients with hepatic impairment. Monitor closely in patients with severe hepatic disease.

    Breztri Aerosphere Pharmacokinetics

    Absorption

    Budesonide: Following inhaled administration of Breztri Aerosphere in subjects with COPD, Cmax occurred within 20 to 40 minutes. Steady state is estimated to be achieved after approximately 1 day of repeated dosing of Breztri Aerosphere via population pharmacokinetic analysis and the AUC0-12 is approximately 1.3 times higher than after the first dose. 

    Glycopyrrolate: Following inhaled administration of Breztri Aerosphere in subjects with COPD, Cmax occurred within 2 to 6 minutes. Steady state is estimated to be achieved after approximately 3 days of repeated dosing of Breztri Aerosphere via population pharmacokinetic analysis and the AUC0-12 is approximately 1.8 times higher than after the first dose. 

    Formoterol Fumarate: Following inhaled administration of Breztri Aerosphere in subjects with COPD, Cmax occurred within 20 to 60 minutes. Steady state is estimated to be achieved after approximately 2 days of repeated dosing with Breztri Aerosphere via population pharmacokinetic analysis and the AUC0-12 is approximately 1.4 times higher than after the first dose.

    Distribution

    Budesonide: The estimated budesonide apparent volume of distribution at steady-state in subjects with COPD is approximately 1200 L, via population pharmacokinetic analysis. Over the concentration range of 1-100 nmol/L, mean plasma protein binding of budesonide ranged from 86% to 87%. 

    Glycopyrrolate: The estimated glycopyrronium apparent volume of distribution at steady-state in subjects with COPD is approximately 5500 L, via population pharmacokinetic analysis. Over the concentration range of 2-500 nmol/L, plasma protein binding of glycopyrronium ranged from 43% to 54%. 

    Formoterol Fumarate: The estimated formoterol apparent volume of distribution at steady-state in subjects with COPD is approximately 2400 L, via population pharmacokinetic analysis. Over the concentration range of 10-500 nmol/L, plasma protein binding of formoterol ranged from 46% to 58%.

    Metabolism

    Budesonide: In vitro studies with human liver homogenates have shown that budesonide was rapidly and extensively metabolized. Two major metabolites formed via CYP3A4 catalyzed biotransformation have been isolated and identified as 16α-hydroxyprednisolone and 6ß-hydroxybudesonide.  

    Glycopyrrolate: Based on information from the published literature, and an in vitro human hepatocyte study, metabolism plays a minor role in the overall elimination of glycopyrronium. CYP2D6 was found to be the predominant enzyme involved in the metabolism of glycopyrronium. 

    Formoterol Fumarate: The primary metabolism of formoterol is by direct glucuronidation and by Odemethylation followed by conjugation to inactive metabolites. Secondary metabolic pathways include deformylation and sulfate conjugation. CYP2D6 and CYP2C have been identified as being primarily responsible for O-demethylation. 

    Elimination

    Budesonide: Budesonide was excreted in urine and feces in the form of metabolites. Only negligible amounts of unchanged budesonide have been detected in the urine. The effective half-life of budesonide in subjects with COPD derived via population pharmacokinetic analysis was ~5 hours. 

    Glycopyrrolate: After IV administration of a 0.2 mg radiolabeled glycopyrronium, 85% of dose recovered was recovered in urine 48 hours post-dose and some of radioactivity was also recovered in bile. The effective half-life of glycopyrronium in subjects with COPD derived via population pharmacokinetics analysis was ~15 hours. 

    Formoterol Fumarate: The excretion of formoterol was studied in 6 healthy subjects following simultaneous administration of radiolabeled formoterol via the oral and IV routes. In that study, 62% of the drug related radioactivity of formoterol was excreted in the urine while 24% was eliminated in the feces. The effective half-life of formoterol in subjects with COPD derived via population pharmacokinetics analysis was ~10 hours.

    Breztri Aerosphere Interactions

    Interactions

    Not for use with other drugs containing LABAs. Caution with concomitant strong CYP3A4 inhibitors (eg, long-term ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). Extreme caution with MAOIs, tricyclics, or drugs known to prolong QTc interval. Increased risk of reduction in bone mineral density with anticonvulsants, oral corticosteroids. Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Concomitant xanthine derivatives, steroids, or diuretics may potentiate hypokalemia. Caution with non-K+-sparing diuretics. Antagonized by β-blockers; if needed, use cardioselective agents if no acceptable alternatives. Additive effects with concomitant other anticholinergic-containing drugs; avoid.

    Breztri Aerosphere Adverse Reactions

    Adverse Reactions

    Upper RTI, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, UTI, cough, sinusitis, diarrhea; paradoxical bronchospasm, hypersensitivity reactions, cardiovascular effects.

    Breztri Aerosphere Clinical Trials

    Clinical Trials

    The approval was based on data from two multicenter, double-blind, phase 3 trials (Trial 1 and 2) that evaluated the efficacy and safety of Breztri Aerosphere in adults with moderate to very severe COPD who remained symptomatic while receiving 2 or more inhaled maintenance treatments for COPD for at least 6 weeks prior to screening.

     Trial 1 (Clinicaltrials.gov Identifier: NCT02465567) included 8588 patients with a history of 1 or more moderate or severe exacerbations in the year prior to screening, post-bronchodilator FEV1/FVC ratio less than 0.7 and the post-bronchodilator FEV1 less than 65% predicted normal value. Patients were randomly assigned 1:1:1:1 to receive Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate 320 mcg/18 mcg/9.6 mcg), budesonide, glycopyrrolate and formoterol fumarate [BGF MDI 160 mcg/18 mcg/9.6 mcg] (the BGF MDI 160 mcg/18 mcg/9.6 mcg dosing regimen is not approved), glycopyrrolate and formoterol fumarate [GFF MDI 18 mcg/9.6 mcg], or budesonide and formoterol fumarate [BFF MDI 320 mcg/9.6 mcg], all administered twice daily. The primary endpoint was the rate of moderate to severe COPD exacerbations.

    Results showed that treatment with Breztri Aerosphere achieved a statistically significant reduction in the rate of moderate or severe COPD exacerbations over 52 weeks compared with GFF MDI (24% lower: rate ratio, 0.76; 95% CI, 0.69-0.83; P <.001) and BFF MDI (13% lower: rate ratio, 0.87; 95% CI, 0.79-0.95; P =.0027). Moreover, Breztri Aerosphere demonstrated an increase in on-treatment FEV1 AUC0-4 and trough FEV1 at week 24 compared with GFF MDI and BFF MDI. 

     Trial 2 (ClinicalTrials.gov Identifier: NCT02497001) included 1896 patients who were not required to have a history of moderate or severe exacerbations in the year prior to screening. Patients were randomly assigned 2:2:1:1 to receive Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate 320 mcg/18 mcg/9.6 mcg), glycopyrrolate and formoterol fumarate [GFF MDI 18 mcg/9.6 mcg], budesonide and formoterol fumarate [BFF MDI 320 mcg/9.6 mcg], or open-label active comparator, all administered twice daily.

    The primary endpoints were FEV1 area under the curve from 0-4 hours (FEV1 AUC0-4) at Week 24 for Breztri Aerosphere compared to BFF MDI and change from baseline in morning pre-dose trough FEV1 at Week 24 for Breztri Aerosphere compared to GFF MDI.  

    Results showed that Breztri Aerosphere demonstrated an increase in on-treatment FEV1 AUC0-4 at Week 24 relative to BFF MDI and an increase in mean change from baseline in morning pre-dose trough FEV1 at Week 24 compared with GFF MDI. The median time to onset on Day 1, defined as a 100 mL increase from baseline in FEV1, was within 5 minutes in subjects receiving Breztri Aerosphere 320 mcg/18 mcg/9.6 mcg. Treatment with Breztri Aerosphere 320 mcg/18 mcg/9.6 mcg reduced the annual rate of on-treatment moderate or severe COPD exacerbations compared with GFF MDI 18 mcg/9.6 mcg (rate ratio [95% CI]: 0.48 [0.37-0.64]), and compared with BFF MDI 320 mcg/9.6 mcg (rate ratio [95% CI]: 0.82 [0.58-1.17]). 

    Health-Related Quality of Life 

    In both trials, health-related quality of life was assessed using the St. George’s Respiratory Questionnaire (SGRQ) responder analysis which was defined as an improvement in SGRQ score from baseline of 4 or more. 

    In Trial 1, the on-treatment percentage of SGRQ responders at Week 24 was greater for subjects treated with Breztri Aerosphere 320 mcg/18 mcg/9.6 mcg (50%) compared with both GFF MDI 18 mcg/9.6 mcg (43%; odds ratio 1.4; 95% CI, 1.2-1.5) and BFF MDI 320 mcg/9.6 mcg (45%; odds ratio 1.2; 95% CI, 1.1-1.4). Similar differences between treatments were observed at Week 52. 

    In Trial 2, the on-treatment percentage of SGRQ responders at Week 24 was greater for subjects treated with Breztri Aerosphere 320 mcg/18 mcg/9.6 mcg (50%) compared with both GFF MDI 18 mcg/9.6 mcg (44%; odds ratio 1.3; 95% CI, 1.0-1.6) and BFF MDI 320 mcg/9.6 mcg (43%; odds ratio 1.3; 95% CI, 1.0-1.7). 

    Breztri Aerosphere Note

    Not Applicable

    Breztri Aerosphere Patient Counseling

    Patient Counseling

    Not for Treatment of Acute Symptoms 

    • Inform patients that Breztri Aerosphere is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta2-agonist such as albuterol. 

    • Instruct patients to seek medical attention immediately if they experience any of the following:  

      • Decreasing effectiveness of inhaled, short-acting beta2-agonists  

      • Need for more inhalations than usual of inhaled, short-acting beta2-agonists  

      • Significant decrease in lung function as outlined by the health care practitioner 

    • Advise patients to not stop treatment with Breztri Aerosphere without physician guidance since symptoms may recur after discontinuation.

    Do Not Use Additional Long-acting Beta2-agonists or Anticholinergics

    • Instruct patients not to use other LABA or anticholinergic medicines

    Oropharyngeal Candidiasis

    • Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. Treat with appropriate local or systemic (i.e., oral) antifungal therapy if oropharyngeal candidiasis develops, while still continuing therapy with Breztri Aerosphere, but at times therapy with Breztri Aerosphere may need to be temporarily interrupted under close medical supervision. 

    • Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.

    Pneumonia

    • Advise patients to contact their healthcare providers if they develop symptoms of pneumonia.

    Immunosuppression and Risk of Infections 

    • Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay.

    • Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex.

    Hypercorticism and Adrenal Suppression  

    • Advise patients that Breztri Aerosphere may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to Breztri Aerosphere.

    Paradoxical Bronchospasm 

    • Advise patients to discontinue Breztri Aerosphere and contact their healthcare provider right away if paradoxical bronchospasm occurs.

    Hypersensitivity Reactions, including Anaphylaxis  

    • Instruct patients to discontinue Breztri Aerosphere if hypersensitivity reactions occur (e.g., anaphylaxis, angioedema, rash, urticaria).

    Reduction in Bone Mineral Density

    • Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.

    Ocular Effects such as Cataracts or Glaucoma

    • Inform patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations. 

    • Advise patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion, and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develops.

    Worsening of Urinary Retention 

    • Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately if any of these signs or symptoms develop.

    Risks Associated with Beta-agonist Therapy

    • Inform patients of adverse effects associated with beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness. Instruct patients to consult a healthcare practitioner immediately should any of these signs or symptoms develop.

    Cost Savings Program

    Breztri Zero Pay Savings Program: https://www.breztri.com/breztri-zero-pay.html

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