Physical Characteristics

ALVESCO® (ciclesonide) Inhalation Aerosol is one of the smallest particle ICSs*

img-alvesco-small-particle-chart

*Clinical significance of this nonclinical information is unknown.

Particle size of ICS medications, Mass Median Aerodynamic Diameter (µm)

Mass Median Aerodynamic Diameter is the diameter of the particle at the median within the range of weights of aerodynamic particles.

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With its small particle size and high lung deposition, ALVESCO®(ciclesonide) Inhalation Aerosol was deposited throughout the lung.*1

52% of the delivered ALVESCO® (ciclesonide) Inhalation Aerosol dose was deposited in the lungs†§1

img-alvesco-scintigraphy-chart

§Based on 2-dimensional (2D) scintigraphy.

Clinical significance of this nonclinical information is unknown.

Study Design: Single-dose, open-label, nonrandomized study performed in 12 patients with mild asthma. Patients received a single dose of 99mtechnetium (Tc)-ciclesonide HFA 320 mcg ex-actuator (400 mcg ex-valve). The primary study variable was the total and regional distribution of ciclesonide in the lungs, oropharynx, and exhaled air.1

The ALVESCO® (ciclesonide) Inhalation Aerosol that was deposited in the lung was distributed throughout the airways¶,†,1

img-alvesco-deposition-graph

 

Clinical significance of this nonclinical information is unknown.

Study Design: Single-dose, open-label, nonrandomized study performed in 12 patients with mild asthma. Patients received a single dose of 99mtechnetium (Tc)-ciclesonide HFA 320 mcg ex-actuator (400 mcg ex-valve). The primary study variable was the total and regional distribution of ciclesonide in the lungs, oropharynx, and exhaled air.1

References:
1. Newman S, Salmon A, Nave R, Drollmann A. High lung deposition of 99mTc-labeled ciclesonide administered via HFA-MDI to patients with asthma. Respir Med. 2006;100(3):375-384.
2. Kamin WES, Genz T, Roeder S, et al. Mass output and particle size distribution of glucocorticosteroids emitted from different inhalation devices depending on various inspiratory parameters. J Aerosol Med. 2002;15(1):65-73.
3. Yang TT, Li S, Wyka B, Kenyon D. Drug delivery performance of the mometasone furoate dry powder inhaler. J Aerosol Med. 2001;14(4):487-494.
4. Data on file. Sunovion Pharmaceuticals Inc.
5. Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000;94(suppl B):S3-S9.
6. Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998;12(6):1346-1353.
7. Rohatagi S, Derendorf H, Zech K, Nave R, Banerji D. PK/PD of inhaled corticosteroids: the risk/benefit of inhaled ciclesonide [abstract]. J Allergy Clin Immunol. 2003;111(suppl 2):S218.
8. Leach CL, Bethke TD, Boudreau RJ, et al. Two-dimensional and three-dimensional imaging show ciclesonide has high lung deposition and peripheral distribution: a nonrandomized study in healthy volunteers. J Aerosol Med. 2006;19(2):117-126.

 

 

Important Safety Information & Indication

ALVESCO is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

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

Indication
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.