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PRODUCT: Alvesco

COMPANY: Sepracor

PHARMACOLOGIC CLASS: Corticosteroid

ACTIVE INGREDIENTS: Ciclesonide 80mcg/inh, 160mcg/inh; metered-dose inhaler.

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

PHARMACOLOGY: Alvesco is a metered-dose oral inhaler product with a dose counter that delivers ciclesonide, a nonhalogenated corticosteroid, to the airways using HFA-134 as a propellant. Ciclesonide is a prodrug that is hydrolized to its active metabolite, desciclesonide, 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.

CLINICAL TRIALS: 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.

ADULTS: 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.

CHILDREN: Not recommended.

CONTRAINDICATIONS: Not for primary treatment of acute attack.

PRECAUTIONS: Infections. If exposed to chickenpox or measles, consider immune-globulin 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.

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

HOW SUPPLIED: Inhaler 80mcg/inh—6.1g, (60 inh) Inhaler 160mcg/inh—6.1g (60 inh), 9.6g (120 inh)

Facts about asthma

• According to numbers from the National Center for Health Statistics, 16.1 million community-dwelling adults (7.3%) and 6.8 million children (9.4%) had asthma in 2006.

• In 2005, Puerto Ricans had an asthma prevalence rate 125% higher than the rate for non-Hispanic white people and 80% higher than the rate for non-Hispanic black people. When only race is considered, American Indians and Alaska Natives and black people had a 25% higher prevalence than white people. Females had a 40% higher prevalence rate than males.

• In 2005, an estimated 4.2% of people (12.2 million) had at least one asthma attack in the previous year. Among those with current asthma, about 55% had at least one asthma attack in the previous year. Asthma attack prevalence decreased with age: 5.2% of children (3.8 million) had an asthma attack in the previous year compared to 3.9% of adults (8.4 million). Puerto Ricans had the highest asthma attack prevalence, 140% higher than the rate for non-Hispanic white people. American Indians and Alaska Natives had a 40% higher prevalence rate than white people. Females had about a 50% higher prevalence rate than males.

• In 2005, health care visits for asthma included 12.8 million to office-based physicians, 1.3 million to hospital outpatient settings, and 1.8 million to hospital emergency departments; 3,884 people died from asthma in 2005.

Data from The National Center for Health Statistics. www.cdc.gov/nchs. Accessed September 11, 2008.