INDICATION AND USAGE FOR ALVESCO® (ciclesonide inhalation aerosol)
ALVESCO Inhalation Aerosol is a prescription medicine used for the control and prevention of asthma in adults and children 12 years of age and older.

Important Limitations of Use:

• ALVESCO is NOT for the relief of acute bronchospasm and does not treat sudden symptoms of an asthma attack such as wheezing, cough, shortness of breath, and chest pain or tightness. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.
• ALVESCO is NOT indicated for children under 12 years of age. It is not known if ALVESCO is safe and effective in children 11 years of age and younger.

Do not use your ALVESCO Inhalation Aerosol near heat or an open flame.

IMPORTANT SAFETY INFORMATION

Who should not use ALVESCO Inhalation Aerosol? Do not use ALVESCO:

• to treat status asthmaticus or other sudden symptoms of asthma. ALVESCO is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler such as albuterol, during a sudden asthma attack.
• if you are allergic to ciclesonide or any of the ingredients in ALVESCO.

What should I tell my healthcare provider before using ALVESCO?

Before you use ALVESCO, tell your healthcare provider if you have or have had eye problems such as increased ocular pressure, glaucoma, or cataracts; have any infections including tuberculosis or ocular herpes simplex; have not had or been vaccinated for chicken pox or measles; are pregnant or plan to become pregnant (it is not known if ALVESCO will harm your unborn baby); are breastfeeding or plan to breastfeed (talk to your healthcare provider about the best way to feed your baby if you are using ALVESCO).

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

How should I use ALVESCO?

Use ALVESCO exactly as your healthcare provider tells you to use it. Do not take more of your medicine or take it more often than your healthcare provider tells you.

You must use ALVESCO regularly. It may take 4 weeks or longer after you start using ALVESCO for your asthma symptoms to get better. Do not stop using ALVESCO even if you are feeling better, unless your healthcare provider tells you to. If your symptoms do not improve or get worse, call your healthcare provider.

What are the possible side effects of ALVESCO?

ALVESCO may cause serious side effects, including:

• Thrush (Candida), a fungal infection of your nose, mouth, or throat. Tell your healthcare provider if you have discomfort or pain in your throat, have hoarseness in your voice or have any redness or white colored patches in your mouth or throat. Rinse your mouth after you use your ALVESCO.
• 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. Symptoms of an infection may include fever, pain, aches, chills, feeling tired, nausea, or vomiting.
• Adrenal insufficiency, a condition in which the adrenal glands do not make enough steroid hormones. Your healthcare provider will follow you closely if you take steroids by mouth and are having them decreased (tapered) or you are being switched to ALVESCO. People have died while steroids are being decreased and when people have been switched from steroids by mouth to inhaled steroids like ALVESCO.
  • Call your healthcare provider right away if you have any symptoms such as tiredness, weakness, dizziness, or nausea or vomiting that does not go away.
• Decreased bone mass (bone mineral density). People who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass which can affect bone strength.
• Slowed or delayed growth in children. A child’s growth should be checked regularly while using ALVESCO.
• Eye problems such as glaucoma and cataracts.
• Increased wheezing (bronchospasm) can happen right away after using ALVESCO. Stop using ALVESCO and use an inhaled fast-acting bronchodilator (rescue inhaler) right away. Tell your healthcare provider right away so that a new medicine can be prescribed to control your asthma.

What are the most common side effects of ALVESCO? The most common side effects with ALVESCO include headache, swelling of nose and throat (nasopharyngitis), swelling of the sinuses (sinusitis), throat pain, upper respiratory infection, joint pain (arthralgia), nasal congestion, and pain in arms, legs, and back. These are not all of the possible side effects with ALVESCO. Tell your healthcare provider about any side effect that bothers you or does not go away.

To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or at medinfoUS@covispharma.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please also see the Full Prescribing Information, including Patient Information.