Overview

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.

Symptoms Dymista treats

Dymista® 125/50 delivers:

Effective treatment for the full range of:

Ocular symptoms1†
  • Itchy eyes
  • Red eyes
  • Watery eyes
Nasal symptoms1†
  • Nasal congestion
  • Nasal itch
  • Sneezing
  • Rhinorrhoea

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

Established efficacy:

Symptoms Dymista treats

Established short and long term safety profile, with no restriction on duration of use1-5

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.

References:

  1. Dymista® 125/50 Product Information.
  2. Meltzer E, et al. Int Arch Allergy Immunol. 2013;161(4):369–77.
  3. Hampel FC, et al. Ann Allergy Asthma Immunol. 2010;105(2):168–73.
  4. Bousquet J, et al. J Allergy Clin Immunol Pract. 2018;6(5):1726–32.
  5. Price D, et al. J Investig Allergol Clin Immunol. 2013;23(7):495–503.
  6. Carr W, et al. J Allergy Clin Immunol. 2012;129(5):1282–9.
  7. Mylan Data on File. Dymista® 125/50 Clinical Study Report December 2010.
  8. Bernstein JA. Expert Opin Pharmacother. 2013;14(15):2101–13.
  9. Berger WE, et al. J Allergy Clin Pharm Immunol Pract. 2014;2(2):179–85.

PI & PBS Information

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

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

Dosing & Administration

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.

Dymista spray technique

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

Cleaning Dymista spray nozzle

References:

  1. Dymista® 125/50 Product Information.
  2. National Asthma Council Australia. Intranasal spray technique for people with allergic rhinitis (2017). Available at: https://d8z57tiamduo7.cloudfront.net/resources/Intranasal-Spray-Technique.pdf. Accessed March 2023.
  3. Scadding GK, et al. Clin Exp Allergy 2008;38(1):19-42.

Treatment Guidelines

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

Treatment Guidelines for Allergic Rhinitis

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

References:

  1. Tan R, et al. J Allergy Clin Immunol Pract. 2018;6(5):1717-1725.
  2. Tan R, et al. Asthma Res Pract. 2017;3:8.
  3. ASCIA Allergic Rhinitis Clinical Update. Information for Healthcare Professionals, 2020.
  4. Therapeutic Guidelines Allergic Rhinitis, 2020.
  5. Dymista® 125/50 Product Information.
  6. Azep® Nasal Spray Product Information.

AR Educational Series presented by Dr C Worsnop

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

Patient Resources

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