INDICATION AND USAGE
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

Important Limitations of Use:

ALVESCO is NOT indicated for the relief of acute bronchospasm.
ALVESCO is NOT indicated for children under 12 years of age

IMPORTANT SAFETY INFORMATION

Contraindications

• ALVESCO is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
• ALVESCO is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue, and pharynx, have been reported.

Warnings & Precautions

• Local effects: The development of localized infections of the mouth and pharynx with Candida albicans have occurred. When such an infection develops, it should be treated with appropriate local or systemic therapy while remaining on treatment with ALVESCO, but at times therapy with ALVESCO may need to be interrupted. Patients should rinse the mouth after inhalation of ALVESCO.
• Acute asthma episodes: ALVESCO is not a bronchodilator and is not indicated for rapid relief of bronchospasm or other acute episodes of asthma. Patients should be instructed to contact their physician immediately if episodes of asthma not responsive to their usual doses of bronchodilators occur during the course of treatment with ALVESCO. During such episodes, patients may require therapy with oral corticosteroids.
• Immunosuppression: Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. ALVESCO can cause potential worsening of existing tuberculosis: fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients can occur. Use caution in patients with above because of the potential for worsening of these infections.
• Transferring from systemic corticosteroid therapy: Particular care is needed for patients who are transferred from systemically active corticosteroids to ALVESCO because deaths due to adrenal insufficiency have occurred in asthmatic patients. Patients should taper slowly from systemic corticosteroids if switching to ALVESCO.
• Hypercorticism: It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients particularly when ALVESCO is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ALVESCO should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and management of asthma.
• Reduction in bone mineral density: Decreases in bone mineral density have been observed with long-term administration of inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.
• Effect on growth: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ALVESCO.
• Glaucoma and cataracts: Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids, including ALVESCO. Patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts should be closely monitored.
• Bronchospasm: If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with ALVESCO should be discontinued.

The most common adverse reactions (≥3% incidence and greater than placebo) in clinical trials were headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity, and back pain.

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

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