Healthcare Professionals

For asthma control, consider starting with ALVESCO® (ciclesonide) Inhalation Aerosol

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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ALVESCO is one of the smallest particle ICSs

ALVESCO formulation delivers small particle size

ALVESCO demonstrated high lung deposition9

Clinical significance of this non-clinical data is unknown.

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 reduced symptoms for improved asthma control13,14

In patients previously on bronchodilators and/or ICS, ALVESCO was well tolerated13,14

Adrenal function: ALVESCO was comparable to placebo15

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.

Please see accompanying full Prescribing Information.

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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; September 2011.

13. Berger WE, Kerwin E, Bernstein DI, Pedinoff A, Bensch G, Karafilidis J. Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids. Allergy Asthma Proc. 2009;30(3):304-314.

14. Meltzer EO, Korenblat PE, Weinstein SF, Noonan M, Karafilidis J. Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc. 2009;30(3):293-303.

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.

ALVESCO, with its small particle size, reaches the
   large and small airways to treat inflammation in
   the lungs—the root of the problem.

Available in 2 strengths for convenient dosing
   (80 mcg per actuation and 160 mcg per actuation)


Allows people to see remaining doses available

Only ALVESCO...

Reduces
Co-pays to $17 for EVERY Rx!

with the ALVESCO Savings Program†

* Most insured patients will pay no more than $17 monthly with a maximum benefit of $75 per fill. Restrictions apply and co-pay amounts may vary. See full program rules and eligibility.

INDICATION for ALVESCO® (ciclesonide) INHALATION AEROSOL

ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. ALVESCO is NOT indicated for the relief of acute bronchospasm.


IMPORTANT SAFETY INFORMATION FOR ALVESCO

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.

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.

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.

Orally inhaled corticosteroids may cause reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ALVESCO.

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.

If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting inhaled bronchodilator.

The most common adverse reactions in clinical trials 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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ALVESCO is a registered trademark of Nycomed GmbH, used under license.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd., and is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd. This site is intended for U.S. residents 18 years of age or older.

© 2012 Sunovion Pharmaceuticals Inc. Marlborough, MA 01752. All rights reserved. 11/2012 ALVV064-12