INDICATION FOR ALVESCO^® (ciclesonide) INHALATION AEROSOL

ALVESCO is for the long-term treatment of asthma as preventative therapy in adults and adolescents 12 years of age and older. ALVESCO is NOT indicated for the relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION FOR ALVESCO

ALVESCO is NOT a rescue inhaler and should not be used for relief of sudden symptoms of shortness of breath during an asthma attack. Use a fast-acting rescue medicine (such as a levalbuterol or albuterol inhaler) to relieve sudden symptoms if you have an asthma attack. You should contact your healthcare professional if an asthma attack does not respond to your rescue medicine or you need to use your rescue medicine more often than usual.

You should not use ALVESCO if you are allergic to ciclesonide or any of the ingredients in ALVESCO. Rare cases of severe allergic reactions, including swelling of the lips, tongue and throat, have been reported.

Yeast infections of the mouth and throat (thrush) have occurred in some ALVESCO patients. Rinse your mouth after you inhale each dose of ALVESCO. If you develop a yeast infection, it should be treated by a healthcare professional.

Patients taking ALVESCO are at a possible increased risk of infection due to a weakened immune system that may occur when taking a steroid medicine. Tell your healthcare professional if you have had tuberculosis (TB) or any other infections before or while using ALVESCO, or if you are exposed to chickenpox or measles.

If you took an oral (by mouth) steroid previously and are having the dose decreased, or you have been switched to ALVESCO from an oral steroid, tell your healthcare professional right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). These may be symptoms of a potentially life-threatening condition in which your body does not produce enough natural steroids.

Using inhaled steroid medicines for a long time may put you at greater risk for decreased bone mass (which can cause bones to become weaker).  Inhaled corticosteroids including ALVESCO may cause slowed growth in children and adolescents.  Your healthcare professional should monitor your bone health and the growth of children and adolescents taking ALVESCO. 

Glaucoma, increased pressure in the eye, and cataracts have been seen in patients who received inhaled steroid medications, including ALVESCO. Your healthcare professional should monitor you especially if you have a change in vision or have a history of increased pressure in the eye, glaucoma, and/or cataracts.

As with other inhaled asthma medicines, bronchospasm (a sudden squeezing of the airways) can occur, with wheezing, right after you inhale your dose of ALVESCO. If this happens, stop using ALVESCO and use a rescue medicine right away, such as levalbuterol or albuterol. You should also inform your healthcare professional right away so that your asthma medicine can be re-evaluated.

It is important to take ALVESCO regularly, as prescribed. Do not stop treatment even if you are feeling better, unless told to do so by your healthcare professional. You should contact your healthcare professional if your symptoms do not improve after 4 weeks, or if your condition worsens at any time during treatment. DO NOT inhale more doses or use your ALVESCO inhaler more often than you have been directed.

What are some of the possible side effects of ALVESCO?

The most common side effects with ALVESCO include headache, pain or irritation of the nose and throat, sinus infection, upper respiratory infection (such as the common cold), joint pain, stuffy nose, leg or arm pain, and back pain.

For additional information, please see the full Prescribing Information for ALVESCO.

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.