Frequently Asked Questions About OMNARIS® (ciclesonide) Nasal Spray

 

General questions about OMNARIS® (ciclesonide) Nasal Spray

What is OMNARIS Nasal Spray?
How does OMNARIS Nasal Spray work?

Questions about nasal allergies

What are nasal allergies?
What is the difference between seasonal (outdoor) and year-round (indoor) allergies?

Questions about how OMNARIS® (ciclesonide) Nasal Spray works

What is the active ingredient in OMNARIS Nasal Spray?
Is OMNARIS a steroid?
Does OMNARIS have a taste or smell?
How effective is OMNARIS Nasal Spray?
How quickly does OMNARIS Nasal Spray start to work?
How long does OMNARIS Nasal Spray work?
Can OMNARIS Nasal Spray be used in children younger than 12 years of age?
What are the most common side effects of OMNARIS Nasal Spray?

Questions about using OMNARIS® (ciclesonide) Nasal Spray

How much does OMNARIS Nasal Spray cost?
Can I get a sample of OMNARIS Nasal Spray?
How much OMNARIS Nasal Spray do I use each day?
How long does OMNARIS Nasal Spray last?
How do I use OMNARIS Nasal Spray?
Why does OMNARIS Nasal Spray contain a foil pouch?
How long can OMNARIS Nasal Spray be used after opening/removing the foil pouch?
What happens if my OMNARIS Nasal Spray freezes?

What is OMNARIS® (ciclesonide) Nasal Spray?
OMNARIS is a nasal steroid spray for people with seasonal or year-round allergies. It contains a medication called ciclesonide, which works to relieve the inflammation that causes nasal allergy symptoms, such as sneezing, itchy nose, runny nose, and congestion.

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How does OMNARIS® (ciclesonide) Nasal Spray work?
OMNARIS Nasal Spray works by reducing allergic inflammation, a major cause of nasal allergy symptoms like sneezing, runny, itchy nose, and congestion.

To learn more, please see Patient Information and Important Safety Information.

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What are nasal allergies?
Nasal allergies (also called simply "allergies" or "hay fever", or by its medical term, "allergic rhinitis"), is a condition where your nasal passages become swollen and irritated due to allergic inflammation. Nasal allergies may be seasonal or year-round.

To learn more, please see Patient Information and Important Safety Information.

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What is the difference between seasonal (outdoor) and year-round (indoor) allergies?
Seasonal allergic rhinitis — or seasonal allergies — occurs only at certain times of the year, when you are exposed to certain seasonal allergens such as tree, grass, or ragweed pollen. Perennial allergic rhinitis — also called "year-round" or "indoor" allergies — may occur throughout the year, when you are exposed to certain allergens such as pet dander or dust.

To learn more, please see Patient Information and Important Safety Information.

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What is the active ingredient in OMNARIS® (ciclesonide) Nasal Spray?
The ingredient in OMNARIS Nasal Spray is ciclesonide (sye-KLES-oh-nide), a drug that is converted in the nasal passages to an active form, des-ciclesonide — an effective anti-inflammatory agent that treats nasal allergy symptoms like sneezing, runny, itchy nose, and congestion.

To learn more, please see Patient Information and Important Safety Information.

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Is OMNARIS® (ciclesonide) Nasal Spray a steroid?
OMNARIS is an intranasal steroid. It is NOT the same as an anabolic steroid — the kind of steroid you may hear about some athletes misusing. Intranasal steroids are very effective for relieving nasal allergy symptoms because they reduce the inflammation inside the nasal passages that causes symptoms.

Like all steroid nasal sprays, OMNARIS may cause slowed growth in children. The growth of children using OMNARIS should be monitored routinely by a healthcare professional.

As with other steroids, there may be side effects. The most common side effects that may occur with OMNARIS Nasal Spray are headache, nosebleed, sore throat and ear pain. To learn more, please see Patient Information and Important Safety Information.

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Does OMNARIS® (ciclesonide) Nasal Spray have a taste or smell?
OMNARIS Nasal Spray is a unique formulation that is scent-free, taste-free, and alcohol-free.

To learn more, please see Patient Information and Important Safety Information.

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How effective is OMNARIS® (ciclesonide) Nasal Spray?
In clinical trials, OMNARIS Nasal Spray was shown to significantly improve nasal allergy symptoms including sneezing, runny, itchy nose, and congestion in people with seasonal or year-round nasal allergy symptoms.

OMNARIS® (ciclesonide) Nasal Spray is for the treatment of nasal allergy symptoms associated with seasonal allergies in adults and children 6 years of age and older, and with year-round allergies in adults and adolescents 12 and older. It is for use in the nose only.

The most common side effects that may occur with OMNARIS Nasal Spray are headache, nosebleed, sore throat and ear pain.

These are not all the possible side effects of OMNARIS Nasal Spray. For additional information, please see the Important Safety Information.

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How quickly does OMNARIS® (ciclesonide) Nasal Spray start to work?
OMNARIS Nasal Spray may begin to improve nasal allergy symptoms (runny, itchy nose, sneezing, and congestion) within 24-48 hours after the first dose. When using OMNARIS Nasal Spray daily as prescribed, your symptoms will continue to improve over the next 1 to 2 weeks for seasonal allergy symptoms, and over the next 5 weeks for year-round allergy symptoms. If your symptoms do not improve within 2 weeks after taking OMNARIS Nasal Spray or if your condition worsens, you should contact your healthcare professional.

To learn more, please see Patient Information and Important Safety Information.

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How long does OMNARIS® (ciclesonide) Nasal Spray work?
In clinical trials, OMNARIS Nasal Spray resulted in significant improvements in nasal allergy symptoms such as sneezing, runny, itchy nose, and congestion for a full 24-hour period. OMNARIS does not lose its effectiveness over time.

To learn more, please see Patient Information and Important Safety Information.

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Can OMNARIS® (ciclesonide) Nasal Spray be used in children younger than 12 years of age?
For treating seasonal (outdoor) nasal allergy symptoms, OMNARIS Nasal Spray is approved for adults and children 6 years of age and older. For treating year-round (indoor) nasal allergy symptoms, OMNARIS Nasal Spray is approved for adults and adolescents 12 years of age and older.

To learn more, please see Patient Information and Important Safety Information.

If you have any questions about who should use OMNARIS Nasal Spray, please contact a healthcare professional.

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What are the most common side effects of OMNARIS® (ciclesonide) Nasal Spray?
The most common side effects that may occur with use of OMNARIS Nasal Spray are headache, nose bleed, sore throat, and ear pain.

These are not all the possible side effects of OMNARIS Nasal Spray. To learn more, please see Patient Information and Important Safety Information.

Please contact your healthcare professional to discuss any side effects or other concerns while taking OMNARIS Nasal Spray. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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How much does OMNARIS® (ciclesonide) Nasal Spray cost?
The cost of OMNARIS Nasal Spray varies depending on your insurance plan and how you pay for your medicines. You may be eligible for the Relief is Here Co-pay Program. If you qualify, you may be able to reduce your co-pay to $17 on each of your next 12 prescriptions or refills of OMNARIS Nasal Spray. Learn more about how to get OMNARIS for $17.*

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Can I get a sample of OMNARIS® (ciclesonide) Nasal Spray?
Samples of OMNARIS Nasal Spray are available from certain healthcare professionals. Please check with your doctor or other healthcare professional to find out if a product sample is available.

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How much OMNARIS® (ciclesonide) Nasal Spray do I use each day?
The recommended dose of OMNARIS Nasal Spray is 200 micrograms per day, which is two 50-microgram sprays in each nostril, once a day. You should never use more than 2 sprays in each nostril each day unless told to do so by your healthcare professional.

To learn more, please see Patient Information and Important Safety Information.

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How long does OMNARIS® (ciclesonide) Nasal Spray last?
Each bottle of OMNARIS Nasal Spray contains 120 metered sprays after initial priming. This is typically a 30-day supply for most patients.

To learn more, please see Patient Information and Important Safety Information.

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How do I use OMNARIS® (ciclesonide) Nasal Spray?
Before you use OMNARIS Nasal Spray for the first time, each bottle must be gently shaken and then the pump must be primed by pressing eight times. You should receive complete instructions along with your prescription.  To learn more, please see Patient Information and Important Safety Information.

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Why does OMNARIS® (ciclesonide) Nasal Spray contain a foil pouch?
Each bottle of OMNARIS Nasal Spray is packaged in an outer foil pouch, which maintains the stability and integrity of the product.

To learn more, please see Patient Information and Important Safety Information.

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How long can OMNARIS® (ciclesonide) Nasal Spray be used after opening/removing the foil pouch?
After you take the OMNARIS bottle out of the foil pouch, it can be used for 120 sprays (after initial priming) or for 4 months, whichever comes first. After 120 sprays or 4 months, you should discard the OMNARIS bottle.

To learn more, please see Patient Information and Important Safety Information.

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What happens if my OMNARIS® (ciclesonide) Nasal Spray freezes?
If frozen, the proper amount of drug may not be administered with each spray, and the bottle should be discarded.

To learn more, please see Patient Information and Important Safety Information.

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* Most insured patients will pay no more than $17 monthly with a maximum benefit of $50 per fill. Restrictions apply and co-pay amounts may vary.
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Indication and Dosing

OMNARIS® (ciclesonide) Nasal Spray is for the treatment of nasal allergy symptoms associated with seasonal allergies in adults and children 6 years of age and older, and with year-round allergies in adults and adolescents 12 and older. It is for use in the nose only. OMNARIS is used 1 time each day, 2 sprays per nostril.

Important Safety Information

Do not spray OMNARIS Nasal Spray in your eyes or directly onto your nasal septum (the wall inside your nose between your two nostrils).

OMNARIS Nasal Spray may cause serious side effects, including:

  • nose bleeds and nasal ulcers. Call your healthcare provider right away if you start to have more nose bleeds or nasal ulcers.
  • hole in the cartilage in the nose (nasal septal perforation). Stop using OMNARIS Nasal Spray and call your doctor right away if you have symptoms of a nasal perforation. Symptoms of nasal perforation may include: crusting in the nose, nosebleeds, runny nose, and a whistling sound when you breathe.
  • thrush (Candida), a fungal infection in your nose, mouth, or throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
  • slow wound healing. You should not use OMNARIS Nasal Spray until your nose has healed, if you have a sore in your nose, if you have had surgery in your nose, or if your nose has been injured.
  • eye problems such as glaucoma and cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use OMNARIS Nasal Spray.
  • immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that may weaken your body's ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use OMNARIS Nasal Spray. Symptoms of an infection may include: fever, pain, aches, chills, feeling tired, nausea, and vomiting.
  • adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Call your healthcare provider right away if you experience the following symptoms of adrenal insufficiency: tiredness, weakness, dizziness, nausea, and vomiting.
  • slowed or delayed growth in children. A child's growth should be checked regularly while using OMNARIS Nasal Spray.
  • allergic reactions. Call your healthcare provider right away if you experience swelling of the lips, tongue, or throat.

The most common side effects that may occur with OMNARIS Nasal Spray are headache, nosebleed, sore throat and ear pain.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OMNARIS Nasal Spray.

For more information, please see the OMNARIS Full Prescribing Information and the OMNARIS Patient Information. You may also call 1-888-394-7377.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

OMNARIS® (ciclesonide) Nasal Spray is available by prescription. Ask your healthcare professional if OMNARIS Nasal Spray is right for you.

The health information contained on this website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. This site is intended for U.S. residents 18 years of age and older. The product discussed on this site may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

OMNARIS is the registered trademark of Takeda GmbH, used under license. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd., is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd.

© 2014 Sunovion Pharmaceuticals Inc. All rights reserved. 03/14 OMN010-14.

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