DYMISTA

What it is

DYMISTA 125/50 is a nasal spray containing azelastine hydrochloride and fluticasone propionate as a fixed combination product, with each spray delivering 125 micrograms of azelastine and 50 micrograms of fluticasone propionate. It is a white, homogeneous and redispersible suspension available as a metered-spray suspension for intranasal administration.

Approved indications

— Symptomatic treatment of moderate to severe allergic rhinitis and rhinoconjunctivitis in adults and children 6 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

Dosing overview

Adults and children 6 years and older should use one spray in each nostril twice daily (morning and evening). DYMISTA 125/50 nasal spray is suitable for long-term use in adults and adolescents 12 years and older. Safety of DYMISTA 125/50 use in children aged 6 to 11 years for longer than 3 months has not been assessed.

Key safety warnings

Somnolence has been reported in clinical studies, though the overall incidence is much lower than that reported for oral antihistamines. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle until they know how they react to the nasal spray. Caution is required if DYMISTA 125/50 is used concomitantly with alcohol or other CNS depressants. Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, surgical operation or injury to the nose or mouth should not use DYMISTA 125/50 until healing has occurred. DYMISTA 125/50 contains benzalkonium chloride, which may cause irritation or swelling inside the nose, especially if used for a long time. Visual disturbance may be reported with corticosteroid use. If a patient presents with symptoms such as blurred vision, increased intraocular pressure or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. Systemic effects such as HPA axis suppression, reduction of bone density and retardation of growth rate in children may occur with intranasal steroids, particularly at high doses prescribed for prolonged periods of time. The growth of paediatric patients receiving nasal corticosteroids, including DYMISTA 125/50, should be monitored routinely.

Contraindications

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

Regulatory history

An Australian Public Assessment Report was approved on 16 December 2013. DYMISTA 125/50 was first listed on the Australian Register of Therapeutic Goods (ARTG 203131) on 14 January 2014.