FDA label 1aa90504-faab-4eb0-9e29-058b6cac81d5

WARNINGS 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, e.g., 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. 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. 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 children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information). If chickenpox develops, treatment with antiviral agents may be considered.

ADVERSE REACTIONS Adult and Adolescent Patients Aged 12 Years and Older: In controlled clinical studies conducted in the US and Canada, a total of 1524 patients ages 12 years and older received treatment with ciclesonide administered intranasally. In studies of 2 to 6 weeks duration in patients 12 years and older, 546 patients were treated with OMNARIS Nasal Spray 200 mcg daily, and in a study of up to one year in duration, 441 patients were treated with OMNARIS Nasal Spray 200 mcg daily. The overall incidence of adverse events for patients treated with OMNARIS Nasal Spray was comparable to that in patients treated with placebo. Adverse events did not differ appreciably based on age, gender, or race. Approximately 2% of patients treated with OMNARIS Nasal Spray 200 mcg in clinical trials discontinued because of adverse events; this rate was similar for patients treated with placebo. Table 4 displays adverse events, irrespective of drug relationship, that occurred with an incidence of 2% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo in clinical trials of 2 to 6 weeks in duration. Table 4 Adverse Events from Controlled Clinical Trials 2 to 6 Weeks in Duration in Patients 12 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis Adverse Event OMNARIS Nasal Spray 200 mcg Once Daily (N =546) % Placebo (N = 544) % Headache 6.0 4.6 Epistaxis 4.9 2.9 Nasopharyngitis 3.7 3.3 Ear Pain 2.2 0.6 In a 52-week long-term safety trial that included 663 adults and adolescent patients (441 treated with ciclesonide: 227 males and 436 females) with perennial allergic rhinitis, the adverse event profile over the treatment period was similar to the adverse event profile in trials of shorter duration. Adverse events considered likely or definitely related to OMNARIS Nasal Spray that were reported at an incidence of 1% or greater of patients and more commonly in OMNARIS Nasal Spray versus placebo were epistaxis, nasal discomfort, and headache. No patient experienced a nasal septal perforation or nasal ulcer during long-term use of OMNARIS Nasal Spray. While primarily designed to assess the long-term safety of OMNARIS Nasal Spray 200 mcg once daily, this 52-week trial demonstrated greater decreases in total nasal symptom scores with OMNARIS Nasal Spray versus placebo treated patients over the entire treatment period. Pediatric Patients Aged 6 to 11 Years: Two controlled clinical studies 2 and 12 weeks in duration were conducted in the US and Canada and included a total of 1282 patients with allergic rhinitis ages 6 to 11 years, of which 913 were treated with OMNARIS (ciclesonide) Nasal Spray 200 mcg, 100 mcg or 25 mcg daily. The overall incidence of adverse events for patients treated with OMNARIS Nasal Spray was comparable to that in patients treated with placebo. Adverse events did not differ appreciably based on age, gender, or race. In clinical trials, 1.6% and 2.7% of patients treated with OMNARIS Nasal Spray 200 mcg or 100 mcg, respectively, discontinued because of adverse events; these rates were lower than the rate in patients treated with placebo (2.8%). Table 5 displays adverse events, irrespective of drug relationship, that occurred with an incidence of 3% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo. Table 5 Adverse Events from Controlled Clinical Trials 2 to 12 Weeks in Duration in Patients 6 to 11 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis Adverse Event OMNARIS Nasal Spray 200 mcg Once Daily (N =380) % Placebo (N = 369) % Headache 6.6 5.7 Nasopharyngitis 6.6 5.4 Pharyngolaryngeal pain 3.4 3.3 Pediatric Patients Aged 2 to 5 Years: Two controlled clinical studies 6 and 12 weeks in duration were conducted in the US and included a total of 258 patients 2 to 5 years of age with perennial allergic rhinitis, of which 183 were treated with OMNARIS Nasal Spray 200 mcg, 100 mcg or 25 mcg daily. The distribution of adverse events was similar to that seen in the 6 to 11 year old children.

<table width="60%" ID="iecbbd7b9-6cc1-4f54-870e-bba1d8d416ce"> <caption>Table 4 Adverse Events from Controlled Clinical Trials 2 to 6 Weeks in Duration in Patients 12 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis</caption> <col align="left"/> <col align="center"/> <col align="center"/> <thead> <tr> <th>Adverse Event</th> <th>OMNARIS Nasal Spray 200 mcg Once Daily (N =546) %</th> <th>Placebo (N = 544) %</th> </tr> </thead> <tbody> <tr> <td>Headache</td> <td>6.0</td> <td>4.6</td> </tr> <tr> <td>Epistaxis</td> <td>4.9</td> <td>2.9</td> </tr> <tr> <td>Nasopharyngitis</td> <td>3.7</td> <td>3.3</td> </tr> <tr> <td>Ear Pain</td> <td>2.2</td> <td>0.6</td> </tr> </tbody> </table>

<table width="60%" ID="ibf0d6b03-ce8f-43a3-8acd-f647d270fe27"> <caption>Table 5 Adverse Events from Controlled Clinical Trials 2 to 12 Weeks in Duration in Patients 6 to 11 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis</caption> <col align="left"/> <col align="center"/> <col align="center"/> <thead> <tr> <th>Adverse Event</th> <th>OMNARIS Nasal Spray 200 mcg Once Daily (N =380) %</th> <th>Placebo (N = 369) %</th> </tr> </thead> <tbody> <tr> <td>Headache</td> <td>6.6</td> <td>5.7</td> </tr> <tr> <td>Nasopharyngitis</td> <td>6.6</td> <td>5.4</td> </tr> <tr> <td>Pharyngolaryngeal pain</td> <td>3.4</td> <td>3.3</td> </tr> </tbody> </table>