Mobile App

Tolerability

In a clinical study,

OMNARIS was well-tolerated with an overall incidence of adverse events (AEs) similar to placebo1

* AEs that occurred with an incidence of 2% or greater and more frequently with OMNARIS than with placebo in controlled clinical trials 2 to 6 weeks in duration in patients aged 12 years and older with SAR or PAR.1

† AEs that occurred with an incidence of 3% or greater and more frequently with OMNARIS than with placebo, with the exception of epistaxis and ear pain, in controlled clinical trials 2 to 12 weeks in duration in patients aged 6 to 11 years with SAR or PAR.1

‡ Data on file.13,14

§ Not reported.

The safety and efficacy of OMNARIS in patients <12 years of age with PAR have not been established.

OMNARIS patients had

  • Low discontinuation rates due to AEs
    • 4.3%, vs placebo (2.7%) in a 52-week, long-term safety trial15
  • Low discontinuation rates due to epistaxis
    • 0.6% in a 4-week SAR safety and efficacy trial¶16
    • 0.5% in a 52-week PAR safety trial¶17
    • No discontinuations due to epistaxis in a 6-week PAR safety and efficacy trial¶18,19

¶No discontinuations due to epistaxis in the placebo-treatment arm.

Small Font
Medium Font
Large Font

email

print

Relief is here program $11 COPAY EVERY TIME*

Best-in-class copay program for qualifying patients on every prescription fill

Find out how

* Restrictions apply. Maximum savings of up to $50, on up to 12 prescription fills of OMNARIS per calendar year. See program rules and eligibility requirements

Desirable
Characteristics,1,2
One Formulation

OMNARIS is

  • Unscented
  • Alcohol-free
  • Low-volume spray
  • BKC preservative-free

Learn more

Access Physician Resources

  • Request Samples
    & Copay Cards
  • View Medication Guide
  • Submit Medical Inquiries

For Your Patients: AllergyManager Mobile App

With pollen forecasts, symptoms diary, refill reminders, and daily allergy tips. Free from the App Store.

See details

OMNARIS (ciclesonide) 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

Patients using drugs that suppress the immune system are more susceptible to infections. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults taking corticosteroids. In clinical studies with OMNARIS Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. Intranasal 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.

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

Rare instances of nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids. Close follow-up is warranted in patients with a change in vision and with a history of glaucoma and/or cataracts.

If recommended doses of intranasal corticosteroids are exceeded, or in susceptible individuals used at recommended dosages, symptoms of hypercorticism may occur. If such changes occur, topical corticosteroids should be discontinued slowly.

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including OMNARIS Nasal Spray, should be monitored routinely.

The most common side effects that may occur with OMNARIS are headache, epistaxis, nasopharyngitis and ear pain.

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.
  • 13. Data on file, CSR 417. Florham Park, NJ: Altana Pharma US, Inc; April 27, 2007.
  • 14. Data on file, CSR 403. Florham Park, NJ: Altana Pharma US, Inc; December 9, 2005.
  • 15. Chervinsky P, Kunjibettu S, Miller DL, et al. Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007;99(1):69-76.
  • 16. Data on file, CSR 401. Florham Park, NJ: Altana Pharma US, Inc; December 21, 2004.
  • 17. Data on file, CSR 404. Florham Park, NJ: Altana Pharma US, Inc; September 12, 2005.
  • 18. Meltzer EO, Kunjibettu S, Hall N, et al. Efficacy and safety of ciclesonide, 200 μg once daily, for the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007;98(2):175-181.
  • 19. Data on file, CSR 402. Florham Park, NJ: Altana Pharma US, Inc; April 5, 2005.

© 2011 Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd., and is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd.
OMNARIS is a registered trademark of Nycomed GmbH, used with permission.