Dymista^® 125/50 (azelastine hydrochloride 125 µg/fluticasone propionate 50 µg)

Indication: symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

Dymista^® 125/50 delivers:

Effective treatment for the full range of:

• Itchy eyes
• Red eyes
• Watery eyes

• Nasal congestion
• Nasal itch
• Sneezing
• Rhinorrhoea

† Successful reductions in rTNSS and rTOSS in efficacy and safety studies of Dymista^® 125/50¹

Established efficacy:

Established short and long term safety profile, with no restriction on duration of use^1-5

Dymista^® 125/50 was well tolerated in both the first two weeks of treatment and through 52 weeks, with the majority of adverse events classified as mild^*1-5

*Across four phase-III, short-term 14-day clinical studies1,2 and one phase-III, long-term 52-week safety study³

Abbreviations: FP, fluticasone propionate; INCS, intranasal corticosteroid; RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; rT7SS, reflective total of 7 symptom scores; rTNSS, reflective total nasal symptom score; rTOSS, reflective total ocular symptom scores; TNSS, total nasal symptom score; TOSS, total ocular symptom score.

PBS Information: This product is not listed on the PBS.

Before prescribing, please review the full Product Information available here.

Dymista^® 125/50 (azelastine/fluticasone propionate) spray technique

Correct technique delivers Dymista^® 125/50 to the right part of the nose and helps to avoid spray getting into the patient’s throat and being swallowed. This can ensure the patient get the full benefits of Dymista^® 125/50.

Like with any nasal spray, cleaning the Dymista^® 125/50 spray nozzle helps to make sure your patient receives the right dose every time.

Help ensure patients are using the right Allergic Rhinitis medications

Up to 9 in 10 allergic rhinitis (AR) Australian patients may experience moderate-severe AR symptoms.¹ While there is a range of treatments available for AR, up to 85% of patients self-select inappropriate medications and would benefit from HCP intervention.^1,2

ASCIA Pharmacotherapy Guidelines³

For intermittent mild symptoms, Australasian Society of Clinical Immunology and Allergy (ASCIA) guidelines recommend a non-sedating oral OR intranasal antihistamine.³ For persistent and/or moderate-severe symptoms, an intranasal corticosteroid OR combination intranasal corticosteroid with antihistamine are first-line options.³

Dymista^® 125/50 (azelastine/fluticasone propionate) combination nasal spray is a first-line option for persistent mild, and moderate-severe AR symptoms.^3,5 Azep^® (azelastine) nasal spray is a first-line option for intermittent mild AR symptoms.^3,6

Intermittent: <4 days/week or <4 weeks
Persistent: ≥4 days/week & ≥4 weeks
Mild: Patients experience normal sleep, no impairment of daily activities, sport or leisure, normal work and school performance, and no troublesome symptoms.
Moderate-severe: Patients experience one or more of the following: abnormal sleep, impairment of daily activities, sport or leisure, abnormal work and school performance, and troublesome symptoms.

Cease oral antihistamine use before starting combination corticosteroid/antihistamine intranasal treatment. Combining oral and intranasal antihistamine therapy does not confer additional benefit.⁴

Figure reproduced from the ASCIA Information for Health Professionals: Allergic Rhinitis Clinical Update

Click here to access full ASCIA Allergic Rhinitis Clinical Update

Research Review^™ Product Review of Dymista^® 125/50 (azelastine/fluticasone priopionate)

In Australia, Dymista^® is approved for the treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children aged ≥12 years.^1* This Research Review™ publication first reviews the pharmacological properties of Dymista^®, in particular its onset of action, and summarises key clinical trials of Dymista^® in patients with moderate to severe allergic rhinitis. It then reviews real-world studies investigating the effectiveness of Dymista^® for control of allergic rhinitis symptoms and the reduction of the impact of symptoms on sleep quality and daily life, across different allergic rhinitis populations.

* Where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

Independent expert commentary provided by Associate Professor Raewyn Campbell

Raewyn Campbell currently works as a dedicated Rhinologist and Skull Base surgeon in Australia. Raewyn completed 3 international fellowships in Rhinology and Skull Base surgery in Auckland, New Zealand and Philadelphia and Columbus, USA. Raewyn has published multiple journal articles and book chapters and has presented at specialist conferences worldwide. She is actively involved in teaching medical students and otorhinolaryngology/ENT trainees, and teaches at rhinology and skull base courses locally and internationally. Raewyn has also trained surgeons internationally and is actively involved in ongoing rhinology and skull base research. She is on the editorial boards for the Australian Journal of Otolaryngology and Rhinology (Frontiers in Allergy special edition) and is a reviewer for multiple academic journals. She is currently undertaking a PhD at The University of Sydney. Raewyn has an active interest in both paediatric and adult otolaryngology and rhinology.

Take-home messages

• EUFOREA guidelines recommend fixed-combination intranasal H₁-antihistamine + intranasal corticosteroid as first-line therapy for patients with difficult-to-treat allergic rhinitis and/or failure of previous treatments⁸
• Dymista^® 125/50 (azelastine/fluticasone propionate) is approved in Australia for the treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children aged ≥12 years¹*
• Dymista^® has a rapid onset of action, with significant improvement in total nasal symptom score from 5 min after administration (p≤0.04 vs baseline) in an environmental exposure chamber study¹⁵
• Dymista^® resulted in a 44-64% greater improvement in nasal symptoms compared with fluticasone propionate and azelastine monotherapies in key clinical trials of patients with moderate to severe seasonal allergic rhinitis³
• Real-world studies have confirmed the effectiveness of Dymista^® for control of allergic rhinitis symptoms, and for reducing the impact of symptoms on sleep quality and activities of daily life^24-26
  • Significant improvement occurred regardless of IgE sensitivity and/or presence of comorbidities, including asthma (p<0.0001 vs baseline)^25,26
• The favourable safety profile of Dymista^® has also been confirmed in real-world studies, with a very low rate of adverse events (approximately 1%) and no reports of serious events.^24,26

* Where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

Expert’s concluding remarks

Allergic rhinitis is a risk factor for the development or exacerbation of asthma, has significant negative impacts on sleep, quality of life, productivity and driving ability and is increasing in prevalence in Australia.^2,25,35,39 Therefore, management of allergic rhinitis is crucial to the Australian population. However, most Australians self-manage their allergic rhinitis symptoms with multiple medications without consulting their doctor, and achieve suboptimal results.^30,48 Patients with allergic rhinitis who consult a health professional for guidance in the management of their disease have better outcomes than those who self-manage.⁴⁷ Therefore, the role of the physician/healthcare worker is critical to the diagnosis and management of allergic rhinitis and to the education of this patient population.

Overall, Dymista^®, a combination non-sedating antihistamine (azelastine) and second-generation corticosteroid (fluticasone propionate) nasal spray, has a faster rate of effect and a superior impact on nasal and ocular symptoms of allergic rhinitis with a favourable adverse effect profile compared to single drug regimens currently available.^3,19-22 The majority of any corticosteroid in Dymista^® that is swallowed will undergo first-pass metabolism, thereby not entering the systemic circulation and impacting serum cortisol levels.^12,13,23 Further, Dymista^® is convenient, simple to use and achieves superior penetration into the nasal cavity than using two or more individual sprays.¹⁷ The safety and efficacy of Dymista^® has been demonstrated by tightly controlled clinical trials^19,20,22,23 and by real-world trial data,^24-26 meaning these findings are reliable and applicable to the general allergic rhinitis population.

A combined intranasal corticosteroid and antihistamine spray is currently recommended as a first-line treatment option for any patient with more than intermittent and mild allergic rhinitis symptoms both in Australia and internationally.^2,7 As most Australians with allergic rhinitis rate their disease as moderate or severe,³⁰ the majority of the Australian population with allergic rhinitis would benefit from this treatment.

Click here to read the full Research Review™ publication and in-text references on the Product Review of Dymista^®

An expert video on combination nasal spray for allergic rhinitis

Dr Jessica Tattersall, an Allergist and Medical Rhinologist, explains the role of combined corticosteroid and antihistamine nasal spray Dymista^® 125/50 (azelastine/fluticasone propionate) in the treatment of allergic rhinitis. Watch the video for a summary of this clinical study.

In this 3-minute video, she discusses:

• Prevalence and disease burden of allergic rhinitis in Australia
• The consequences of untreated allergic rhinitis for patients
• The synergistic effects of intranasal corticosteroid and antihistamine
• Ways to overcome barriers to nasal spray treatment

Research Review™ Educational Series on Allergic Rhinitis

This Research Review™ publication outlines various treatment strategies recommended for the management of allergic rhinitis (AR), with a focus on the place of combination therapy (intranasal antihistamine and intranasal corticosteroid). This review also outlines how mobile technology, such as the MASK-air® app, can provide insights into how AR is treated and managed in the real world.

Expert commentary provided by Dr Christopher Worsnop

Dr Worsnop is a respiratory and sleep physician at the Austin Hospital in Melbourne. His degrees were obtained at the University of Melbourne including a Doctorate of Philosophy by thesis on the activity of respiratory pump and upper airway muscles during sleep onset. Dr Worsnop is a Fellow of the Royal Australasian College of Physicians, a Fellow of the Thoracic Society of Australia and New Zealand (TSANZ), a Fellow of the American College of Chest Physicians and a Life Member of the University of Melbourne Graduate Union. In 2013 he was made a Fellow of the Melbourne Medical School Academy of Clinical Teachers. He chairs the Respiratory special interest group of the Australasian Sleep Association, and is vice-chair of the TSANZ COPD special interest group.

Take-home messages

• AR is a local IgE-mediated allergic reaction, involving a response of the nasal airways to inhaled allergens.
• Nearly 20% of Australians (more than 4.6 million people) have reported AR, with this disorder impacting an individual’s social life, sleep, school/work, and daily activities and reducing their quality of life.
• AR is often under-diagnosed and under-treated, despite the availability of effective pharmacological treatments.
• Available treatment options for AR include:
• non-sedating oral and/or intranasal H1-antihistamines;
• intranasal corticosteroid (INCS)s; and
• fixed combinations of an INCS and an intranasal H₁-antihistamine.
• Recent guidelines and algorithms recommend the use of fixed combinations of an INCS/intranasal H₁-antihistamine in the management of AR.
• The next-generation Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines note that a fixed combination of an INCS and an intranasal H₁-antihistamine is more effective than intranasal corticosteroid (INCS)s in patients with AR, and that it is effective within minutes.
• Real-world data obtained by mobile technology are offering new insights into AR phenotypes and their management, with the data increasingly influencing guideline recommendations.
• In particular, the MASK-air^® digital tool can be used to help both patients and their healthcare professionals track AR symptoms and treatment.

Expert’s concluding remarks

AR is common in Australia. Some people present to have the symptoms relieved and quality of life improved. In addition, we should ask about AR symptoms in patients with chronic cough, asthma, and snoring and obstructive sleep apnoea. Treating AR in these groups of patients may also help with their other conditions.

AR is an allergic type of inflammation predominantly mediated by eosinophils. As eosinophils are well compressed by corticosteroids, corticosteroids have become the main treatment for AR. Systemic corticosteroids have significant side effects. These adverse effects can be avoided by using corticosteroids topically – that is intranasal corticosteroids.

When intranasal corticosteroids are combined with antihistamines, symptoms will be brought under control more quickly, and more people will have their AR symptoms controlled in the long term.

When using these nasal sprays, patients should clean their noses beforehand, so that the drugs can be deposited on the nasal mucosa.

Clinicians should consider the use of electronic reminders and tracking with an app such as MASK-air^®. This can help improve patients’ adherence. It can also provide insights for the clinician into the reasons behind a poor response to treatment.

Click here to read the full Research Review™ publication and in-text references on the Allergic Rhinitis Educational Series

Resources for your patients

Here are some of the resources available to share with your patients.

Dymista^® 125/50 (azelastine/fluticasone propionate) patient booklet: It is important for patients to use Dymista^® correctly to ensure they get the full benefits it offers. This booklet provides detailed information on the correct spray technique and how to clean the spray nozzle to make sure your patients receive the right dose.

Download Dymista^® patient booklet

Ear, Nose and Throat Anatomy Diagram: The downloadable PDF includes detailed drawings of the pharynx and associated structures including the ear, larynx, oral cavity and paranasal sinuses. You can draw, add notes and share this with your patients to communicate with them about their condition and treatment.

Download Ear, Nose and Throat Anatomy Diagram

Respiratory Anatomy Diagram: The downloadable PDF includes detailed drawings of the lungs, and associated structures such as the alveoli, bronchitis, obstructive sleep apnoea and paranasal sinuses. You can draw, add notes and share this with your patients to communicate with them about their condition and treatment.

Download Respiratory Diagram