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Healthcare Professionals

ALVESCO (ciclesonide), is a prescription inhaled corticosteroid for maintenance treatment of persistent asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

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A key contributor to asthma: Inflammation in small airways1,2

ALVESCO formulation delivers small particle size†

ALVESCO demonstrated high lung deposition9

ALVESCO delivers medication with low systemic exposure

ALVESCO delivers powerful asthma control

...in patients not currently taking ICS therapy12,13
...in patients switched from another ICS therapy12,14

ALVESCO reduces symptoms for improved asthma control

In patients previously on bronchodilators and/or ICS, ALVESCO was well tolerated

Adrenal function: ALVESCO was comparable to placebo

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References:
1. Balzar S, Chu HW, Strand M, Wenzel S. Relationship of small airway chymase-positive mast cells and lung function in severe asthma. Am J Respir Crit Care Med. 2005; 171:431-439.

2. Taha RA, Minshall EM, Miotto D, et al. Eotaxin and monocyte chemotactic protein-4 mRNA expression in small airways of asthmatic and nonasthmatic individuals. J Allergy Clin Immunol. 1999;103:476-483.

3. 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;12:1346-1353.

4. Cohen J, Douma WR, ten Hacken NH, Vonk JM, Oudkerk M, Postma DS. Ciclesonide improves measures of small airway involvement in asthma [published online February 20, 2008]. Eur Respir J. doi: 10.1183/09031936.00082407.

5. Martin RJ. Therapeutic signifi cance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002;109:S447-S460.

6. Yang TT, Li S, Wyka B, Kenyon D. Drug delivery performance of the mometasone furoate dry powder inhaler. J Aerosol Med. 2001;14:487-494. (MMAD was calculated using data on p 492.)

7. 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.

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;19:117-126.

9. 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; 100:375-384.

10. 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.

11. Clark A, Borgström L. In vitro testing of pharmaceutical aerosols and predicting lung deposition from in vitro measurements. In: Bisgaard H, O'Callaghan C, Smaldone GC, eds. Drug Delivery to the Lung. New York, NY: Marcel Dekker; 2002:105-142. Lenfant C, exec ed. Lung Biology in Health and Disease; vol 162.

12. ALVESCO [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc; May 2008.

13. Data on file, Study EFC6164(3031).

14. Data on file, Study EFC6163(3030).

15. Szefler S, Rohatagi S, Williams J, Lloyd M, Kundu S, Banerji D. Ciclesonide, a novel inhaled steroid, does not aff ect hypothalamic-pituitary-adrenal axis function in patients with moderate-to-severe persistent asthma. Chest. 2005;128:1104-1114.

16. Kaiser/HRET Survey of Employer-Sponsored Health Benefits, 2000-2007.

For asthma control, start with ALVESCO

Deliver powerful results with...

Potent anti-inflammatory effect directly to the lungs

Convenient dosing available in 2 strengths (80 mcg per actuation and 160 mcg per actuation)

- Dose indicator (counter)

Only ALVESCO...

Knocks Down
Copays to $0 for EVERY Rx!

with the ALVESCO Instant Rebate Program†

* Maximum benefit is $75 off, on up to 12 prescription fills of ALVESCO per year. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, and where prohibited by law. Click here for program rules.

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

IMPORTANT SAFETY INFORMATION

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. In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans occurred in 32 of 3038 patients treated with ALVESCO. Most cases of candida infection were mild to moderate.

ALVESCO is NOT indicated for the relief of acute bronchospasm.

Patients who are on immunosuppressant doses of corticosteroids are more susceptible to infections and should avoid exposure to chickenpox and measles and seek prompt medical attention if exposed. 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.

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 products containing 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.

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