Dymista^® (Fluticasone Propionate, Azelastine Hydrochloride)

Dymista^® is a combination nasal spray indicated for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis, in adults and adolescents, aged 12 years and older, if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.¹

Dymista^® contains two active ingredients, fluticasone propionate (FP) and azelastine (AZ), which have different modes of action and show synergistic effects in terms of improvement of allergic rhinitis symptoms.¹

Efficacy

Evidence to support the efficacy of Dymista^® comes from meta-analysis and double-blind placebo-controlled clinical trials in 4,172 patients aged 12+ with seasonal and perennial rhinitis.^1,2

Dymista^®:

• Leads to greater symptom relief than using either fluticasone propionate or azelastine alone in seasonal allergic rhinitis^1,2
• Significantly improves all symptoms of allergic rhinitis with onset of action within 30 minutes in clinical practice²
• Leads to clinical improvement of symptoms days earlier than with fluticasone propionate or azelastine alone¹
• Treats ocular symptoms of allergy better than fluticasone propionate or azelastine alone²
• Demonstrates efficacy over fluticasone propionate in perennial allergic rhinitis³
• Has shown statistically significant relief of nasal symptoms 5 minutes after administration, compared to placebo⁴

The need to treat the symptom spectrum

Current monotherapy does not provide sufficient control in many patients. A survey of 990 patients with allergic rhinitis recruited by 161 GPs in France found that the vast majority of treated patients remained symptomatic.¹

Therapeutic indication²

Dymista^® is indicated for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.

Adults and adolescents (12 years and older)²

One actuation in each nostril twice daily (morning and evening).

Children below 12 years²

Dymista^® nasal spray is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group.

Elderly²

No dose adjustment is required in this population.

Renal and hepatic impairment²

There are no data in patients with renal and hepatic impairment.

Duration of treatment²

Dymista^® nasal spray is suitable for long-term use.

The duration of treatment should correspond to the period of allergenic exposure.

Method of administration²

Dymista^® nasal spray is for nasal use only.

Instructions for use:³

Preparing the spray

1. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap
2. The first time the nasal spray is used, you must prime the pump by squirting it into the air
3. Prime the pump by putting two fingers on either side of the spray pump and place your thumb on the bottom of the bottle
4. Press down and release the pump 6 times until a fine mist appears
5. Now your pump is primed and ready to use
6. If the nasal spray has not been used for more than 7 days, you will need to re-prime the pump once by pressing down and releasing the pump

Using the spray

1. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap
2. Blow your nose to clear your nostrils
3. Keep your head tilted downwards towards your toes. Do not tilt head backwards
4. Hold the bottle upright and carefully insert the spray tip into one nostril
5. Close other nostril with your finger, rapidly press down once and sniff gently at the same time
6. Breathe out through your mouth
7. Repeat in your other nostril
8. Breathe in gently, and do not tilt your head back after dosing. This will stop the medicine going into your throat and causing an unpleasant taste

Dymista® Nasal Spray, Suspension (azelastine hydrochloride/ fluticasone propionate)
Prescribing Information

Presentation: Nasal spray suspension. Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.
Indications: Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if treatment with intranasal antihistamine or glucocorticoid alone is not considered sufficient.
Dosage and administration: Adults and adolescents (12 years and older): One actuation into each nostril twice daily.
Children below 12 years: not recommended as safety and efficacy has not been established in this age group.
Contra-indications: Hypersensitivity to azelastine hydrochloride or fluticasone propionate or any of the other ingredients in this medicine.
Warnings and precautions: Avoid concomitant use with ritonavir. Systemic effects of nasal corticosteroids may occur. Systemic exposure in severe liver disease may be increased. Dymista® may result in clinically significant adrenal suppression. Patients may experience blurred vision or other visual disturbances. Monitor patients who experience changes in vision or have a history of ocular pressure, glaucoma and/or cataract. If adrenal function is impaired, take care when changing medication to Dymista®. In patients with infections, recent surgery or injury to nose or mouth, weigh benefits against risks of use. Contains benzalkonium chloride. Long term use may cause oedema of the nasal mucosa. Experience of use in pregnancy and lactation is limited. Dymista® should only be used if the potential benefit justifies the potential risk. Dymista® has minor influence on ability to drive and use machines.
Undesirable Effects: Epistaxis, headache, dysgeusia, unpleasant smell, hypersensitivity reactions including anaphylactic reactions, angioedema, bronchospasm, glaucoma, increased intraocular pressure, cataract, blurred vision, septal perforation, nasal irritation, nasal ulcers, throat irritation, nausea, dizziness, sleepiness, fatigue, rash, dry mouth, growth retardation may be possible in adolescents receiving prolonged treatment and growth should be monitored regularly. Consult the Summary of Product Characteristics for other side effects.

Package Quantities and Basic Price (UK): £14.80 for 23g bottle. Each spray (0.14g) contains 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate.
Legal category: POM. Product Licence Holder: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Tel 0845 460 0000. Marketing Authorisation Number: PL 46302/0162. Date of preparation of prescribing information: UK-DYM-2024-00021 November 2024

Please continue to report suspected adverse drug reactions with any medicine or vaccine to the MHRA through the Yellow Card Scheme. It is easiest and quickest to report adverse drug reactions online via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively, you can report via some clinical IT systems (EMIS/SystmOne/Vision/ MiDatabank) or by calling the Commission on Human Medicines (CHM) free phone line: 0800-731-6789. Adverse reactions/events should also be reported to MAH at e-mail address: pv.uk@viatris.com.

Contraindications

Hypersensitivity to the active substances or to any of the excipients.¹

Side Effects

The SPC for Dymista lists epistaxis, headache, dysgeusia (unpleasant taste), unpleasant smell as very common or common adverse reactions.¹

Dysgeusia may be experienced after administration, often due to incorrect method of application, namely tilting the head too far backwards during administration.¹

For a full list of adverse reactions, precautions, contraindications, and method of use please consult the SPC.¹

https://www.medicines.org.uk/emc/product/9450