OMNARIS

What it is

OMNARIS is a metered-dose nasal spray containing ciclesonide. Each actuation delivers 50 μg ciclesonide in a volume of 70 μL. Ciclesonide is a pro-drug that is enzymatically hydrolysed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide), which has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120 times higher than the parent compound.

Approved indications

— Treatment of seasonal allergic rhinitis in adults and children 6 years of age and older. — Treatment of perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Dosing overview

The recommended dose of OMNARIS is 200 μg per day administered as 2 actuations (50 μg/actuation) in each nostril once daily. The maximum total daily dosage should not exceed 2 actuations in each nostril (200 μg/day).

Key safety warnings

**Hypersensitivity and cross-reactivity.** Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of intranasal corticosteroids. Patients with a known hypersensitivity reaction to other corticosteroid preparations should use caution when using ciclesonide nasal spray since cross reactivity to other corticosteroids including ciclesonide may also occur. **Infection risk.** Patients who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. **Local nasal effects.** Epistaxis and rare instances of nasal septum perforation have been reported following the intranasal application of corticosteroids. Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred. **Growth in children.** Intranasal corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route. **Visual disturbances.** Rare instances of cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids. **Systemic effects and HPA-axis.** Although systemic effects have been minimal with recommended doses of OMNARIS, any such effect is likely to be dose dependent. Therefore, larger than recommended doses of OMNARIS should be avoided. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, for example, joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress.

Contraindications

OMNARIS is contraindicated in patients with a hypersensitivity to ciclesonide or any of its ingredients.

Regulatory history

The TGA approved Omnaris Nasal Spray on 28 November 2011 for the treatment of seasonal and perennial allergic rhinitis, following a comprehensive evaluation of its quality, nonclinical, and clinical data. OMNARIS ciclesonide 50 microgram per actuation nasal spray was first listed on the ARTG on 16 December 2011.