Company:

Sepracor

Corticosteroid

Ciclesonide 80mcg/inh, 160mcg/inh; metered dose inhaler.

Maintenance treatment of asthma as prophylactic therapy in patients ≥12 years of age.

Alvesco is a metered-dose oral inhaler product with a dose counter that delivers ciclesonide, a non-halogenated corticosteroid, to the airways using HFA-134 as a propellant. Ciclesonide is a prodrug that is hydrolized to its active metabolite, des-ciclesonide, which is further metabolized in the liver to other active metabolites.

The exact mechanism of action of corticosteroids in the management of asthma is unknown, however they have been shown to have a wide range of activity against mediators of inflammation involved in the inflammatory response seen with asthma.

Six randomized, double-blind, placebo controlled studies were conducted to evaluate the efficacy of Alvesco in the management of mild-to-severe asthma in patients ≥12 years of age.

In patients previously treated with bronchodilators alone, subjects treated with Alvesco had significant improvements in the morning pre-dose FEV₁ at week 16. For this and other measures of asthma control and the need for rescue albuterol, the improvement was greatest in patients given 80mcg twice daily compared to those using 160mcg once daily.

In patients previously maintained on inhaled corticosteroids, the FEV₁ was improved, and asthma symptom scores, AM PEF, and decreased need for rescue albuterol remained stable at 12 weeks for those receiving Alvesco versus those given placebo.

For patients previously maintained on oral corticosteroids, patients using Alvesco 320mcg or 640mcg twice daily significantly reduced their prednisone needs by 47% and 62%, respectively, compared to those on placebo, whose prednisone needs increased by 4%. There was no significant difference seen with Alvesco 640mcg twice daily compared to 320mcg twice daily.

Previously on bronchodilators alone: initially 80mcg twice daily, max 160mcg twice daily. Previously on inhaled corticosteroids: initially 80mcg twice daily; max 320mcg twice daily. Previously on oral corticosteroids (see literature): 320mcg twice daily. Rinse mouth after use; avoid eyes.

Not recommended.

Not for primary treatment of acute attack.

Infections. If exposed to chickenpox or measles, consider immuneglobulin prophylactic therapy. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with inhaled corticosteroids may exacerbate symptoms of adrenal insufficiency (eg, lassitude). Monitor for hypercorticism and HPA axis suppression (if occur reduce dose gradually). Monitor for growth suppression in children. Monitor for changes in vision, increased intraocular pressure, cataracts. Pregnancy (Cat.C). Nursing mothers.

Headache, nasopharyngitis, sinusitis, throat pain, upper respiratory infection, arthralgia, nasal congestion, back pain; rare: bronchospasm, immunosuppression, glaucoma, cataracts, oral candidiasis, decreased bone mineral density.

Inhaler 80mcg/inh—6.1g (60 inh)

Inhaler 160mcg/inh—6.1g (60 inh), 9.6g (120 inh)

8/22/2008