Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Epistaxis, nasal septal perforations, Candida albicans infection, impaired wound healing [see Warnings and Precautions ( 5.1 )] • Cataracts and glaucoma [see Warnings and Precautions ( 5.2 )] • Immunosuppression [see Warnings and Precautions ( 5.3 )] • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions ( 5.4 , 5.5 ), Use in Specific Populations ( 8.4 )] The most common adverse reactions (>2% incidence) included headache, epistaxis, nasopharyngitis, ear pain, and pharyngolaryngeal pain.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below for adults and adolescents 12 years of age and older are based on 3 clinical trials of 2 to 6 weeks duration and one 52-week trial.
In the 3 trials of 2 to 6 weeks duration, 1524 patients (495 males and 1029 females, ages 12 to 86 years old) with seasonal or perennial allergic rhinitis were treated with OMNARIS Nasal Spray 200, 100, 50, or 25 mcg or placebo once daily.
The racial distribution in these three trials included 1374 Caucasians, 69 Blacks, 31 Asians, and 50 patients classified as Other.
The 52-week trial was conducted in 663 patients (227 males and 436 females, ages 12 to 73 years old) treated with OMNARIS Nasal Spray 200 mcg or placebo once daily.
The racial distribution in this trial included 538 Caucasians, 69 Blacks, 16 Asians, and 40 patients classified as Other.
The data from pediatric patients are based upon 4 clinical trials in which 1541 children (871 males and 670 females, ages 2 to 11 years old) with seasonal or perennial allergic rhinitis were treated with OMNARIS Nasal Spray 200, 100, or 25 mcg or placebo once daily for 2 to 12 weeks.
The racial distribution in these four trials included 1136 Caucasians, 273 Blacks, 20 Asians, and 112 patients classified as Other.
5 WARNINGS AND PRECAUTIONS • Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing.
Monitor patients periodically for signs of adverse effects on the nasal mucosa.
Avoid spraying OMNARIS directly onto the nasal septum.
Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
( 5.1 ) • Development of glaucoma or cataracts.
Like all medications, Omnaris can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: