NOW PBS LISTED
For patients with moderate to very severe COPD
BREZTRI AEROSPHERE ®
1,2
*
Protection against exacerbations ^
*
^
Reduction in the rate of moderate † or severe ‡ exacerbations vs GLY / FORM ( p < 0.0001 ) and vs BUD / FORM ( p = 0.0027 ) 1 , 2 §
BREZTRI AEROSPHERE ® is indicated as a maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate , severe , or very severe COPD who require treatment with a combination of ICS , LABA , and LAMA . 1 BREZTRI AEROSPHERE ® is not indicated for the initiation of therapy in COPD . 1
A new fixed dose ICS / LABA / LAMA combination in a pMDI , for patients with moderate to very severe COPD 1
† Moderate exacerbations were defined as events requiring the use of systemic corticosteroids and / or antibiotics for at least 3 days . 1 ‡ Severe exacerbations were defined as events resulting in inpatient COPD-related hospitalisation or COPD-related death . 1 , 2 § ETHOS Study design : A 52-week phase 3 , randomised , double-blind , parallel-group trial to assess the safety and efficacy of BREZTRI ® at two doses of ICS ( 320 / 14.4 / 10 μg and 160 / 14.4 / 10 μg ) compared with GLY / FORM ( 14.4 / 10 μg ) and BUD / FORM ( 320 / 10 μg ) delivered twice daily via pMDI , in symptomatic patients with moderate to very severe COPD and a history of ≥1 exacerbation in the past year ( n = 8,588 ). The primary endpoint was the annual rate of moderate or severe COPD exacerbations . 2 Note : BREZTRI ® 160 / 14.4 / 10 μg BID dose is not registered and therefore the data are not presented . 2
SAFETY : In ETHOS , adverse events that occurred in ≥3 % of patients overall for BREZTRI ®, BUD / FORM and GLY / FORM were nasopharyngitis , COPD , upper respiratory tract infection , pneumonia and bronchitis . 2 The incidence of confirmed pneumonia was 4.2 % with BREZTRI ®, 4.5 % with BUD / FORM and 2.3 % with GLY / FORM . 1 , 2 Please review Product Information for information on other Precautions and Adverse Effects . 1
PBS Information : Authority required ( STREAMLINED ) for the treatment of COPD . Refer to PBS for full authority information .
BEFORE PRESCRIBING PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342 OR WWW . ASTRAZENECA . COM . AU / PI
BREZTRI AEROSPHERE ® ( budesonide 160 µ g / glycopyrronium 7.2 µ g / formoterol ( eformoterol ) fumarate dihydrate 5 µ g ) pressurised metered dose inhaler for oral inhalation . Therapeutic indications : Maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate , severe , or very severe chronic obstructive pulmonary disease ( COPD ) who require treatment with a combination of an inhaled corticosteroid ( ICS ), a long-acting ß2-agonist ( LABA ), and a long-acting muscarinic antagonist ( LAMA ). BREZTRI is not indicated for the initiation of therapy in COPD . Dosage : Adults ≥ 18 years : 2 actuations twice daily . Contraindications : Hypersensitivity to any of the ingredients . Special Warning and Precautions : Not indicated for the treatment of asthma , or for the treatment of acute episodes of bronchospasm , or as rescue therapy to treat an acute COPD exacerbation ; patients transferring from oral corticosteroids ( OCS ) may remain at risk of impaired adrenal function - additional systemic corticosteroid cover should be considered during periods of stress or elective surgery ; discontinue BREZTRI immediately should paradoxical bronchospasm occur ( as with other inhaled medicines , bronchospasm may be life-threatening ); not for use with other medicines containing a LABA or LAMA ; caution in patients with clinically significant cardiovascular disease , thyrotoxicosis or prolonged QTc interval ; possible systemic effects of ICS ( see full PI ); consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term ; hypokalaemia ; hyperglycaemia ; caution in patients with symptomatic prostatic hyperplasia , urinary retention or narrow-angle glaucoma ; an increase in the incidence of pneumonia , including requiring hospitalisation , has been observed in patients with COPD receiving inhaled corticosteroids - physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections can overlap with symptoms of COPD ; oropharyngeal candidiasis ; severely impaired renal or hepatic function – monitor closely and use only if benefit outweighs risk ; BREZTRI should only be used during pregnancy if the expected benefits outweigh the potential risks ( category B3 ); lactation - use only if the expected benefit to the mother outweigh potential risk to the child ; no relevant use in children < 18 years in COPD . See full PI for further information . Interactions : Not for use with other LABA and / or LAMA containing medicines ; strong CYP3A4 inhibitors , e . g . itraconazole , ketoconazole , HIV protease inhibitors , cobicistat containing products ; beta-receptor blockers ; medicines known to prolong QTc interval , e . g . MAOIs , tricyclics antidepressants ; if hypokalaemic , drugs that may potentiate hypokalaemia , e . g . non-potassium sparing diuretics ; other antimuscarinics and sympathomimetics . Adverse effects : Very common ( ≥ 10 %): nasopharyngitis . Common ( ≥ 1 %): COPD , upper respiratory tract infection , pneumonia , bronchitis , back pain , hypertension , dyspnoea , headache , urinary tract infection , influenza , sinusitis , muscle spasm , cough , oral candidiasis , diarrhoea , hyperglycaemia , anxiety , insomnia , palpitations , dysphonia , nausea ; others , see full PI . Date of first approval : 19 July 2021 .
BID = twice daily ; BUD = budesonide ; COPD = chronic obstructive pulmonary disease ; ETHOS = The Efficacy and Safety of Triple Therapy in Obstructive Lung Disease ; FORM = formoterol ; GLY = glycopyrronium ; ICS = inhaled corticosteroid ; LABA = long-acting beta 2 agonist ; LAMA = long-acting muscarinic antagonist ; pMDI = pressurised Metered Dose Inhaler . References : 1 . BREZTRI AEROSPHERE ® Approved Product Information . 2 . Rabe F et al . N Engl J Med . 2020 ; 383 ( 1 ): 35 – 48 .
BREZTRI ® and AEROSPHERE ® are registered trademarks of the AstraZeneca group of companies . Registered user AstraZeneca Pty . Ltd . ABN 54 009 682 311 . 66 Talavera Road , Macquarie Park , NSW 2113 . www . astrazeneca . com . au . For Medical Information enquiries or to report an adverse event or product quality complaint : Telephone 1800 805 342 or via https :// contactazmedical . astrazeneca . com or email Medical Information enquiries to medinfo . australia @ astrazeneca . com . AU-12002 . 001145 . October 2021 .