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Prescribing Information TRIXEO®
(formoterol fumarate dihydrate/ glycopyrronium/budesonide)
Prescribing Information SYMBICORT®
(budesonide/formoterol) COPD 200/6 and 400/12
Prescribing Information BEVESPI®
(glycopyrronium/formoterol fumarate dihydrate)
Adverse Event
Reporting

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  • Bevespi Aerosphere | AstraZeneca UK

The only LABA/LAMA available in a pMDI

BEVESPI AEROSPHERE

(glycopyrronium/formoterol fumarate dihydrate)

  • Dual therapy pMDI
  • Dosing
  • How to use
  • Guidelines
  • Clinical efficacy
  • Safety

BEVESPI AEROSPHERE- The only LABA/LAMA available in a pMDI, for your patients with COPD

BEVESPI AEROSPHERE is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD1

BEVESPI - a dual therapy pMDI with AEROSPHERE technology

astrazeneca_aerosphere_technology astrazeneca_aerosphere_technology

For illustration purposes only. Not to scale.

LAMA: GLYCOPYRRONIUM

Induces bronchodilation through inhibition of the M3 receptor at the smooth muscle1

LABA: FORMOTEROL

Rapidly and effectively relaxes the central and peripheral airways1

Learn more about AEROSPHERE technology
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BEVESPI dosing information

Recommended and maximum BEVESPI dose is1:

COPD_inhaler_dosing_information COPD_inhaler_dosing_information

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.1

 

An overdose of BEVESPI AEROSPHERE may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms, the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and systolic hypertension.1

If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

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How to use the BEVESPI inhaler

Parts of the BEVESPI AEROSPHERE device

labelled_parts_of_COPD_inhaler_device labelled_parts_of_COPD_inhaler_device
labelled_parts_of_COPD_inhaler_device labelled_parts_of_COPD_inhaler_device
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Using BEVESPI

steps_on_how_to_use_COPD_inhaler_device steps_on_how_to_use_COPD_inhaler_device
BEVESPI user guide

Guidelines and approaches for BEVESPI and inhaled therapies in COPD

NICE Guideline [NG115] July 20192

Offer LABA/LAMA if the patient with COPD has no asthmatic features or features suggesting steroid responsiveness, but is limited by symptoms or experiences exacerbations despite initial treatment. 

Click here

GOLD Report 20263

  • Recommends LABA/LAMA as first-line for dual therapy in COPD patients.
  • GOLD no longer recommends starting new patients on ICS/LABA therapy for COPD
Click here
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Outcomes from BEVESPI clinical trials including PINNACLE-1/-2

onset_of_action_icon

ONSET OF ACTION4

At 5 minutes following administration of the first dose on day 1, there was significant improvement in FEV1 from baseline vs placebo (in PINNACLE-1 and PINNACLE-2 studies respective differences were 187 and 186 mL, all p<0.0001)1,4

aerosphere_technology_icon

INNOVATIVE AEROSPHERE DELIVERY TECHNOLOGY5

Aerosphere technology enables effective, consistent dose delivery to the whole lung with lung deposition of 38.4% with BEVESPI AEROSPHERE.5¶

improvements_in_FEV1_icon

IMPROVEMENTS IN FEV14,7*

BEVESPI AEROSPHERE demonstrated statistically significant improvements in trough FEV1 at 24 weeks vs both monocomponents4,6,7

quality_of_life_icon

QUALITY OF LIFE1,4,7

Improvement of Health-related quality-of-life (SGRQ scores) with Bevespi was statistically but not clinically significant at Week 24 vs placebo in PINNACLE-1, PINNACLE-2, and PINNACLE-4 trials.1,4‡

Access BEVESPI user guide

*PINNACLE 1: 59 mL vs glycopyrrolate and 64 mL vs formoterol (both p<0.0001); PINNACLE 2: 54 mL vs glycopyrrolate (p<0.0003) and 56 mL vs formoterol (p<0.0002); PINNACLE 4: 59 mL vs glycopyrrolate and 72 mL vs formoterol (both p<0.0001).

‡Health-related quality of life was measured using the SGRQ. An improvement of 4 points in the SGRQ total score is the minimal clinically important difference.4

¶Based on a phase 1 trial of radiolabelled BEVESPI vs radiolabelled placebo pMDI (n=10). The dose detected in the oropharyngeal and stomach regions was 61% and 67% for BEVESPI and placebo, respectively.5

 

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Safety and side effects of BEVESPI AEROSPHERE

The most common adverse reactions with BEVESPI AEROSPHERE (n=1588) were headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%). Other common adverse reactions included anxiety, dry mouth, chest pain, and urinary tract infection. For full list of adverse reactions please refer to BEVESPI SmPC.1

 

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For your patients uncontrolled on dual therapy:
TRIXEO AEROSPHERE

AEROSPHERE technology is also available in TRIXEO AEROSPHERE (formoterol fumarate dihydrate/glycopyrronium/budesonide), for patients with COPD who are uncontrolled on dual therapy8 

 

TRIXEO AEROSPHERE is indicated as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.8

Find out more about TRIXEO AEROSPHERE

Resources for your patient

Access BEVESPI patient resources here

 

Access resource
patient patient

FEV1, forced expiratory volume in first second; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; SGRQ, St George’s Respiratory Questionnaire, pMDI, pressurised metered dose inhaler; COPD, chronic obstructive pulmonary disease, n, number of patients

  1. BEVESPI AEROSPHERE 5 micrograms/7.2 micrograms pressurised inhalation, suspension. Summary of Product Characteristics.
  2. NICE. Chronic obstructive pulmonary disease in over 16s: diagnosis and management. (NG115), Last updated July 2019.
  3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease: 2026 Report
  4. Martinez FJ et al. Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD. Chest. 2017 151(2):340-357. doi: 10.1016/j.chest.2016.11.028. PMID: 27916620.
  5. Taylor G et al. Gamma scintigraphic pulmonary deposition study of glycopyrronium/formoterol metered dose inhaler formulated using co-suspension delivery technology. Eur J Pharm Sci. 2018;111: 450–457. doi: 10.1016/j.ejps.2017.10.026.
  6. Reisner C et al. 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD. Respir Res. 2017 18(1):157. doi: 10.1186/s12931-017-0636-4. PMID: 28821260; PMCID: PMC5563048.
  7. Lipworth BJ et al. Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA. Int J Chron Obstruct Pulmon Dis. 2018 13:2969-2984. doi: 10.2147/COPD.S171835. PMID: 30310273; PMCID: PMC6167125.
  8. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics.

BEVESPI, TRIXEO and AEROSPHERE are registered trademarks of the AstraZeneca group of companies.

 

 

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling ‌‌‌0‌‌‌8‌‌‌‌‌0‌‌‌‌0‌‌‌ ‌‌7‌‌‌‌‌‌8‌‌‌3‌‌‌ ‌‌0‌‌‌‌‌0‌‌‌‌3‌‌‌‌3‌‌‌.

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