OMNARIS Nasal spray (2019)

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Covis Pharma

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1. Indications and Usage

1.1 Treatment of Seasonal Allergic Rhinitis 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. ...

2. Dosage and Administration

Administer OMNARIS Nasal Spray by the intranasal route only. Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. If the product is ...

3. Dosage Forms and Strengths

OMNARIS Nasal Spray is a metered-dose, manual-pump spray formulation containing a hypotonic aqueous suspension of ciclesonide. Once primed, each actuation of the pump delivers 50 mcg ciclesonide in a volume ...

4. Contraindications

OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray [see Warnings and Precautions (5.3)].

5. Warnings and Precautions

5.1 Local Nasal Effects Epistaxis: In clinical studies of 2 to 52 weeks' duration, epistaxis was observed more frequently in patients treated with OMNARIS Nasal Spray than those who received placebo ...

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)] ...

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been reported in association with post-marketing use of OMNARIS Nasal Spray and are not listed above: nasal congestion, nasal ulcer and dizziness. Because these reactions ...

7. Drug Interactions

In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see Clinical ...

8.1. Pregnancy

Risk Summary There are no data on ONMARIS nasal spray use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is low systemic ...

8.2. Lactation

Risk Summary There are no data on the presence of ciclesonide in human milk, the effects on the breastfed child, or on milk production. It is not known whether nasal spray administration of ciclesonide ...

8.4. Pediatric Use

The safety and effectiveness for seasonal and perennial allergic rhinitis in children 12 years of age and older have been established. The efficacy of OMNARIS Nasal Spray in patients 6 to 11 years of age ...

8.5. Geriatric Use

Clinical studies of OMNARIS Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience ...

10. Overdosage

Chronic overdosage may result in signs or symptoms of hypercorticism [see Warnings and Precautions (5.4)]. There are no data available on the effects of acute or chronic overdosage with OMNARIS ...

11. Description

The active component of OMNARIS Nasal Spray is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy) ...

12.1. Mechanism of Action

Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application. Des-ciclesonide ...

12.2. Pharmacodynamics

Adrenal Function In a 6-week trial in adolescents and adults 12-73 years of age with perennial allergic rhinitis, a daily dose of 200 mcg of OMNARIS Nasal Spray was compared to placebo nasal spray. Dexamethasone ...

12.3. Pharmacokinetics

Absorption Ciclesonide and des-ciclesonide have negligible oral bioavailability (both less than 1%) due to low gastrointestinal absorption and high first-pass metabolism. The intranasal administration ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year carcinogenicity studies in B6C3F1 mice and Wistar rats were conducted to assess the carcinogenic potential of ciclesonide. Ciclesonide demonstrated no tumorigenic potential in a study with mice ...

14. Clinical Studies

14.1 Seasonal and Perennial Allergic Rhinitis Adults and Adolescent Patients 12 Years of Age and Older The efficacy of OMNARIS Nasal Spray was evaluated in 3 randomized, double‑blind, parallel-group, multicenter, ...

16.1. How Supplied

OMNARIS is supplied in an amber glass bottle and provides for nasal delivery with a manual metered pump. OMNARIS Nasal Spray is supplied with an oxygen absorber sachet and enclosed in a foil pouch. The ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Do not freeze. Shake gently before use. Keep out of reach of children.

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Use). 17.1 Local Nasal Effects Patients should be informed that treatment with OMNARIS Nasal Spray may lead to adverse reactions, ...