Safety

ZETONNA® (ciclesonide) Nasal Aerosol Safety Data/ Formulation Characteristics

In short-term trials (2-6 weeks duration) overall incidence of adverse reactions was low and comparable to placebo.*1

Adverse Reaction ZETONNA® (ciclesonide) Nasal Aerosol
74 mcg once daily (n=884)
Placebo (n=892)

Nasal discomfort

3.2% 1.8%

Headache

3.1% 1.2%

Epistaxis

2.9% 2.7%

 

*Adverse reactions that occurred with a frequency of ≥2.0% and greater than placebo from 4 controlled clinical trials 2 to 6 weeks in duration in patients aged 12 years and older with SAR or PAR.

Nasal discomfort includes both nasal discomfort and instillation site discomfort.

In 3 short-term trials and the first 6 weeks of a long-term trial, nasal septal perforations were reported in 2 of 884 patients treated with ZETONNA® (ciclesonide) Nasal Aerosol compared with none of 892 patients treated with placebo1. Both perforations occurred in 2-week SAR trials while none occurred in the longer term trials.

ZETONNA exhibited low discontinuation rates due to
adverse reactions in both SAR and PAR (first 6 weeks)
studies vs placebo in the short-term

• ZETONNA (1.2%) vs placebo (1.3%)1,6

 



In a 6-month safety trial of patients with PAR

  • Discontinuation rates due to local adverse reactions were (1.7%) for ZETONNA® (ciclesonide) Nasal Aerosol vs (0.7%) for placebo1
  • No patients experienced a nasal septal perforation during the long-term trial1
  • Nasal discomfort (5.7%) and epistaxis (11.4%) were more frequently observed in patients treated with ZETONNA compared with short-term trials1

 



ZETONNA® (ciclesonide) Nasal Aerosol had no apparent effect on HPA-axis function.

  • In a 6-week, randomized, double-blind, placebo-controlled trial in adolescents and adults with PAR, daily doses of 148 mcg and 282 mcg of ZETONNA were compared to placebo nasal aerosol. Dexamethasone 6 mg was used as an active control during the last 4 days of the trial. Adrenal function was assessed by 24-hour serum cortisol AUC before and after the treatment.
  • The difference from placebo for the change from baseline in serum cortisol AUC (0-24) was -2.4 mcg•hour/dL (95% CI: -15.1, 10.2) and -0.5 mcg•hour/dL (95% CI: -13.9, 13.0) for 148-mcg/day and 282-mcg/day treatments, respectively.
  • The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and symptoms of corticosteroid withdrawal. Patients transferred to topical steroids after a prolonged period of treatment with a systemic corticosteroid should be carefully monitored. Rapid decreases in systemic corticosteroid dosages in patients taking them for diseases such as asthma or other conditions may cause a severe exacerbation of their symptoms.
  • Before prescribing ZETONNA conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Periodically conduct nasal examinations during treatment. If an adverse reaction (eg, erosion, ulceration, perforation) is noted, discontinue ZETONNA. Counsel patients that ZETONNA should not be sprayed directly on the nasal septum.

ZETONNA® (ciclesonide) Nasal Aerosol gives your allergic rhinitis patients HFA-propelled delivery1

 

*Benzalkonium chloride (BKC) is a preservative contained in many intranasal steroid products and can be an irritant.11
VERAMYST® (fluticasone furoate) is a registered trademark of GlaxoSmithKline.
NASONEX® (mometasone furoate monohydrate) is a registered trademark of Schering Corporation, a subsidiary of Merck & Co., Inc.
OMNARIS® (ciclesonide) is a registered trademark of Takeda GmbH, used under license.

 

References:
1. ZETONNA Prescribing Information. Marlborough, MA: Sunovion Pharmaceuticals Inc.; January 2012.
6. Data on file, Clinical Safety Summary. Sunovion Pharmaceuticals Inc., Malborough, MA.
7. FLONASE® (fluticasone propionate) Nasal Spray Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; August 2007.
8. VERAMYST® (fluticasone furoate) Nasal Spray Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; January 2011.
9. NASONEX® (mometasone furoate monohydrate) Nasal Spray Prescribing Information. Whitehouse Station, NJ: Schering Corporation, a subsidiary of Merck & Co., Inc.; January 2011.
10. OMNARIS® (ciclesonide) Nasal Spray Prescribing Information. Marlborough, MA: Sunovion Pharmaceuticals Inc.; October 2011.
11. Riechelmann H, Deutschle T, Stuhlmiller A, Gronau S, Bürner H. Nasal toxicity of benzalkonium chloride. Am J Rhinol. 2004;18(5):291-299.

Stayability is a registered trademark of Sunovion Pharmaceuticals Inc.
Trademarks and registered trademarks are the property of their respective owners.

Important Safety Information & Indication

In clinical studies local nasal effects of epistaxis, ulcerations, and nasal septal perforations were observed with ZETONNA® (ciclesonide) Nasal Aerosol. In the short-term and long term trials combined, nasal septal perforations were reported in 2 patients of 2335 treated with ZETONNA Nasal Aerosol compared with none of 892 treated with placebo. Both perforations occurred in 2 week SAR trials while none occurred in the longer term trials. In clinical trials with another formulation of ciclesonide, the development of localized infections of the nose or pharynx with Candida albicans has occurred. Corticosteroids can interfere with wound healing.

Prior to initiating therapy, examine patients for evidence of septal perforation, erosions, ulceration, nasal surgery, and trauma. Avoid spraying ZETONNA Nasal Aerosol directly onto the nasal septum. Avoid use in patients with recent septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma. Monitor patients periodically for signs of adverse reactions on the nasal mucosa. Discontinue ZETONNA Nasal Aerosol if erosions, ulcerations or perforations occur.

Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.

ZETONNA Nasal Aerosol is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA Nasal Aerosol. Cases of hypersensitivity reactions following administration of ciclesonide with manifestations such as angioedema, with swelling of the lips, tongue and pharynx have been reported.

Patients who are using immunosuppressant doses of corticosteroids are more susceptible to infections than healthy individuals. Chicken pox and measles can have a more serious or even fatal course in susceptible individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.

When intranasal corticosteroids are used at very high dosages or at the regular dosage in susceptible individuals, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, discontinue ZETONNA Nasal Aerosol slowly.

Corticosteroids may cause a reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving ZETONNA Nasal Aerosol.

In trials 2-6 weeks in duration, the most common adverse reactions that occurred with an incidence of at least 2% and more frequently with ZETONNA Nasal Aerosol than with placebo were nasal discomfort (3.2%), headache (3.1%) and epistaxis (2.9%).

For additional information, please see the ZETONNA Nasal Aerosol Full Prescribing Information.

Indication
ZETONNA® (ciclesonide) Nasal Aerosol is a corticosteroid indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.