Azelastine hydrochloride and fluticasone propionate

(Dymista®)

Dymista®

Drug updated on 12/11/2024

Dosage FormNasal spray (intranasal; 137 mcg azelastine hydrochloride and 50 mcg fluticasone propionate)
Drug ClassHistamine-1 (H1) receptor antagonists and corticosteroids
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • MP-AzeFlu: Demonstrated the highest probability of moderate or large improvements in both Total Nasal Symptom Score and Rhinoconjunctivitis Quality-of-Life Questionnaire among patients with seasonal allergic rhinitis (AR), surpassing the effectiveness of fluticasone furoate and fluticasone propionate.
  • Total Ocular Symptom Score: MP-AzeFlu showed the highest probability of moderate or large improvement in ocular symptoms.
  • Comparison with other drugs: MP-AzeFlu provided faster and more sustained relief of nasal and ocular symptoms, showing superior efficacy over intranasal azelastine, fluticasone propionate alone, and combinations of intranasal corticosteroids with oral antihistamines for comprehensive AR symptom management.
  • Long-term use of MP-AzeFlu was deemed safe with a favorable safety profile across age groups, including children, adults, and those aged 65 years or older; specific adverse effects or safety concerns were not detailed.
  • No comparative safety data were provided between MP-AzeFlu and other medications or combinations.
  • MP-AzeFlu was shown to be safe and effective for children, adults, and adults aged ≥65 years with seasonal or perennial AR, including those with moderate-to-severe disease, providing rapid, sustained symptom relief and quality-of-life improvements across these groups.

Product Monograph / Prescribing Information

Document TitleYearSource
Dymista (azelastine hydrochloride and fluticasone propionate) Prescribing Information.2022Mylan Specialty L.P., Morgantown, WV

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Intranasal antihistamines and corticosteroids in allergic rhinitis: A systematic review and meta-analysis2024The Journal of Allergy and Clinical Immunology
MP-AzeFlu in Moderate-to-Severe Allergic Rhinitis: A Literature Review2021International Archives of Allergy and Immunology

Clinical Practice Guidelines