OMNARIS^® (ciclesonide) Nasal Spray for 24-hour relief of SAR and PAR nasal symptoms

Indication

OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and with perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Important Safety Information

Local nasal effects of OMNARIS and other INS include epistaxis, Candida albicans infection of the nose and pharynx, nasal septal perforation, and impaired wound healing. Patients using OMNARIS over several months or longer should be examined periodically for evidence of adverse effects on the nasal mucosa.

Patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use OMNARIS until healing has occurred.

Nasal corticosteroids may result in the development of glaucoma and/or cataracts. Close monitoring is warranted in patients with a change in vision and/or with a history of increased intraocular pressure, glaucoma and/or cataracts.

Patients using immunosuppressive drugs are more susceptible to infections and should avoid exposure to chickenpox and measles, because they can have a more serious or even fatal course in susceptible patients using corticosteroids. Corticosteroids should be used with caution, if at all, in patients with tuberculosis, untreated fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.

If recommended doses of intranasal corticosteroids are exceeded, or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of OMNARIS should be discontinued slowly.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience corticosteroid withdrawal. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients using OMNARIS.

In clinical trials, adverse events that occurred with an incidence of ≥2% and more frequently with OMNARIS than placebo were headache (6.0%), epistaxis (4.9%), nasopharyngitis (3.7%), and ear pain (2.2%).

For additional information, please see the OMNARIS Full Prescribing Information.

References

• 1. OMNARIS [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; May 2010.
• 2. Meltzer EO. Formulation considerations of intranasal corticosteroids for the treatment of allergic rhinitis. Ann Allergy Asthma Immunol. 2007;98(1):12-21.