*Determined in a study following intravenous administration of 800 mcg of ciclesonide.
Important Safety Information: Patients who are on immunosuppressant doses of corticosteroids are more susceptible to infections and should avoid exposure to chickenpox and measles. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
1. ALVESCO [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc., January 2013.
Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue, and pharynx, have been reported.
The development of localized infections of the mouth and pharynx with Candida albicans have occurred infrequently. When such an infection develops, it may be necessary to interrupt therapy with ALVESCO. Most cases of candida infection were mild to moderate.
ALVESCO is NOT indicated for the relief of acute bronchospasm.
Patients who are using immunosuppressant doses of corticosteroids are more susceptible to infections than healthy individuals. Chicken pox and measles can have a more serious or even fatal course in susceptible individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.
Particular care is needed for patients who are transferred from systemically active corticosteroids due to the potential for adrenal insufficiency. Patients should taper slowly from systemic corticosteroids if switching to ALVESCO.
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.
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.
Orally inhaled corticosteroids may cause reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ALVESCO. To minimize the systemic effects, patients should be titrated to the lowest dosage that effectively controls symptoms.
Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids including ALVESCO. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting inhaled bronchodilator.
The most common adverse reactions occurring at an incidence greater than or equal to 3% in any of the ALVESCO groups and which were more frequent with ALVESCO compared with placebo were headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity, and back pain.
Full Prescribing Information for ALVESCO
ALVESCO® (ciclesonide) Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.