Pharmacy & Therapeutics - March 2008 - (Page 151) Pharmaceutical Approval Update joint or muscular pain, lassitude, and depression, even with their improved respiratory function. Hypercorticism and Adrenal Suppression: Ciclesonide often helps control asthma symptoms with less suppression of HPA function than therapeutically similar oral prednisone. Because each patient’s sensitivity to the effects on cortisol production differs, physicians should consider this fact when they prescribe ciclesonide. Particular care should be taken to observe patients postoperatively or during periods of stress for evidence of inadequate adrenal response. The effects of systemic corticosteroids, such as hypercorticism and adrenal suppression, may occur in a small number of patients, particularly when ciclesonide is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the ciclesonide dosage should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for managing asthma. Reduced Bone Density: Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids. The significance of small changes in bone density in terms of long-term outcomes is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, a family history of osteoporosis, or the chronic use of drugs that can reduce bone mass (such as anticonvulsant agents and oral corticosteroids) should be monitored and treated with established standards of care. Effect on Growth: Orally inhaled corticosteroids may cause a reduced growth rate in children. The growth of these patients who receive ciclesonide routinely should also be monitored (e.g., by stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ciclesonide, the lowest dose that effectively controls symptoms should be used. Glaucoma and Cataracts: Glaucoma and cataracts have been reported after the therapy with inhaled corticosteroids, including ciclesonide. Close monitoring is warranted in patients with a change in vision or a history of increased intraocular pressure, glaucoma, or cataracts. In a comparator control study of one year’s duration, 743 patients 18 years of age and older (mean age, 43.1 years) with moderate, persistent asthma received ciclesonide 320 mcg twice daily; 742 patients were treated with a labeled dose of a comparator inhaled corticosteroid. An ophthalmology examination included visual acuity, measurement of intraocular pressure, and a slit-lamp examination at baseline and at four, eight, and 12 months. Lens opacities were graded. After 52 weeks, class 1 effects, defined as minimally detected changes, were recorded in 36.1% of the ciclesonide-treated patients and in 38.4% of patients using the comparator inhaled corticosteroid. More severe class 3 effects were recorded in 8.1% of the ciclesonide patients and in 9.2% of the comparator patients. Of those patients experiencing a class 3 effect, the incidence of posterior subcapsular opacities was 0.9% with ciclesonide and 0.5% with the comparator agent. Bronchospasm: As with other inhaled asthma drugs, bronchospasm, accompanied by an immediate increase in wheezing, may occur after ciclesonide therapy. The wheezing should be treated immediately with a fast-acting inhaled bronchodilator. Ciclesonide should be discontinued, and an alternative treatment should be instituted. Dosage and Administration: Ciclesonide is inhaled orally. The aerosol should be primed before patients use it for the first time. Patients should activate the canister three times before using the first dose or when the inhaler has not been used for more than 10 days. The time to onset and the degree of symptom relief may vary among patients, and the maximum benefit might not be achieved for four weeks or longer after therapy is initiated. After asthma stability has been achieved, it is best to titrate the drug to the lowest effective dosage to reduce the potential for adverse effects. For patients who do not respond adequately to the starting dose after four weeks, higher doses may provide additional asthma control. The safety and efficacy of ciclesonide, when administered in excess of the highest recommended doses, have not been established. Commentar y: Inhaled corticosteroids are regarded as the gold standard in asthma and allergic rhinitis therapy. They inhibit the activity of proinflammatory cells and promote the production of anti-inflammatory substances. With regular use of these agents, the inflammation in the lungs and airways that underlies the asthma is lessened. Approximately 22 million Americans have asthma. Each year the disease is responsible for nearly two million emergency department visits and accounts for $11.5 billion in health care costs. Every day in America 40,000 people miss school or work because of asthma; 30,000 people have an asthma attack; 5,000 people visit the emergency room; 1,000 people are admitted to the hospital; and 11 people die of this disease. Ciclesonide is activated into des-ciclesonide after its administration. It has potent anti-inflammatory activity and a high affinity for glucocorticoid receptors. Ciclesonide and desciclesonide have negligible bioavailability because of low gastrointestinal absorption and first-pass metabolism, and they can be expected to exert fewer systemic adverse effects. However, this agent does not provide immediate relief of wheezing or breathlessness during sudden, severe, or continuous asthma attacks. In this situation, a quick-acting “reliever” inhaler containing a bronchodilator (albuterol) should be used. Source: www.spectrumscience.com Etravirine (Intelence) Manufacturer: Tibotec Pharmaceuticals, Bridgewater, N.J. Indication: Etravirine is used in combination with at least two other antiretroviral agents for adults with HIV-1 infection. It does not cure the infection or AIDS and does not reduce the risk of passing the virus to other people. Prescribers should consider these points when initiating therapy: 1. The patient’s treatment history is important. When available, testing for resistance should guide the use of etravirine. 2. The use of other active antiretroviral agents with etravirine may increase the likelihood of a treatment response. 3. For patients who have experienced virological failure after a regimen containing a non-nucleoside reverse transcriptase inhibitor (NNRTI), etravirine should not be used in combination with only nucleotide reverse transcriptase inhibitors (NtRTIs). continued on page 157 Vol. 33 No. 3 • March 2008 • P&T® 151 http://www.spectrumscience.com
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