ALVESCO® (ciclesonide) Inhalation Aerosol should be administered by the orally inhaled route. Prime ALVESCO Inhalation Aerosol before using for the first time by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for four weeks or longer after initiation. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dose after 4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ALVESCO when administered in excess of the highest recommended doses has not been established.
The recommended starting dose and the highest recommended dose of ALVESCO Inhalation Aerosol are listed in the following table.
|Previous Therapy||Recommended Starting Dose||Highest Recommended Dose|
|Patients ≥ 12 years who received bronchodilators alone||80 mcg twice daily||160 mcg twice daily|
|Patients ≥ 12 years who received inhaled corticosteroids||80 mcg twice daily||320 mcg twice daily|
|Patients ≥ 12 years who received oral corticosteroids1||320 mcg twice daily||320 mcg twice daily|
1Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.1) in Full Prescribing Information.
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.