Alvesco (Page 2 of 7)

5.5 Hypercorticism and Adrenal Suppression

ALVESCO will often help control asthma symptoms with less suppression of HPA function than therapeutically similar oral doses of prednisone. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing ALVESCO. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

Hypercorticism and adrenal suppression may occur when corticosteroids, including ALVESCO, are used at higher-than-recommended dosages [see Dosage and Administration (2)] or patients at risk for such effects.

5.6 Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term outcomes is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and oral corticosteroids) should be monitored and treated with established standards of care.

5.7 Effect on Growth

Orally inhaled corticosteroids, including ALVESCO, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of ALVESCO have not been established in pediatric patients less than 12 years of age and ALVESCO is not indicated for use in this population. Monitor the growth of pediatric patients receiving ALVESCO routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ALVESCO, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

5.8 Glaucoma and Cataracts

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.

In a comparator control study of one-year treatment duration, 743 patients 18 years of age and older (mean age 43.1 years) with moderate persistent asthma were treated with ALVESCO 320 mcg twice daily and 742 were treated with a labeled dose of a comparator-inhaled corticosteroid appropriate for the patient population. Patients had an ophthalmology examination that included visual acuity, intraocular pressure measurement, and a slit lamp examination at baseline, 4, 8 and 12 months. Lens opacities were graded using the Lens Opacification System III. After 52 weeks, CLASS I effects (minimally detected changes) were recorded in 36.1% of the ALVESCO-treated patients and in 38.4% of patients treated with the comparator-inhaled corticosteroid. The more severe CLASS III effects were recorded in 8.1% of the ALVESCO-treated patients and 9.2% of patients treated with the comparator-inhaled corticosteroid. Of those patients having a CLASS III effect, the incidence of posterior sub-capsular opacities was 0.9% and 0.5% in the ALVESCO- and comparator-treated patients, respectively.

5.9 Paradoxical Bronchospasm

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with ALVESCO should be discontinued and alternative treatment should be instituted.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Oropharyngeal Candidiasis [see Warnings and Precautions (5.1)]
Immunosuppression and Risk of Infections [see Warnings and Precautions (5.3)]
Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.5)]
Reduction in Bone Mineral Density [see Warnings and Precautions (5.6)]
Growth Effects [see Warnings and Precautions (5.7)]
Glaucoma and Cataracts [see Warnings and Precautions (5.8)]

6.1 Clinical Trial Experience

The safety data described below for adult and pediatric patients 12 years of age and older reflect exposure to ALVESCO in doses ranging from 80 mcg to 640 mcg twice daily in five double-blind placebo-controlled clinical trials. Studies with once daily dosing are omitted from the safety database because the doses studied once daily are lower than the highest recommended twice daily doses. The five studies were of 12 to 16 weeks treatment duration, one of which included a safety extension follow-up of one year. In the 12 to 16 week treatment studies, 720 patients (298 males and 422 females) aged 12 years and older were exposed to ALVESCO. In the long-term safety trial, 197 patients (82 males and 115 females) with severe persistent asthma from one of the 12-week trials were re-randomized and treated for up to one year with ALVESCO 320 mcg twice daily.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Pediatric Patients 12 Years of Age and Older

Four of the five trials included a total of 624 patients ages 12 years and older (359 females and 265 males) with asthma of varying severity who were treated with ALVESCO 80 mcg, 160 mcg, or 320 mcg twice daily for 12 to 16 weeks. These studies included patients previously using either controller therapy (predominantly inhaled corticosteroids) or reliever therapy (bronchodilator therapy alone). In these trials, the mean age was 39.1 years, and the majority of the patients (79.0%) were Caucasian. In these trials, 52.3%, 59.8% and 54.1% of the patients in the ALVESCO 80 mcg, 160 mcg, and 320 mcg treatment groups, respectively, had at least one adverse event compared to 58.0% in the placebo group.

Table 2 includes adverse reactions for the recommended doses of ALVESCO that occurred at an incidence of ≥ 3% in any of the ALVESCO groups and which were more frequent with ALVESCO compared to placebo.

Table 2: Adverse Reactions with ≥ 3% Incidence Reported in Patients ≥ 12 Years of Age with ALVESCO in US Placebo-Controlled Clinical Trials in Patients Previously on Bronchodilators and/or Inhaled Corticosteroids

Adverse Reaction

Placebo(N=507)%

ALVESCO

80 mcg BID(N=325)%

160 mcg BID(N=127)%

320 mcg BID(N=172)%

Headache

7.3

4.9

11.0

8.7

Nasopharyngitis

7.5

10.5

8.7

7.0

Sinusitis

3.0

3.1

5.5

5.2

Pharyngolaryngeal pain

4.3

4.3

2.4

4.7

Upper respiratory Inf.

6.5

7.1

8.7

4.1

Arthralgia

1.0

0.9

2.4

3.5

Nasal congestion

1.6

1.8

5.5

2.9

Pain in extremity

1.0

0.3

3.1

2.3

Back pain

2.0

0.6

3.1

1.2

The following adverse reactions occurred in these clinical trials using ALVESCO with an incidence of less than 1% and occurred at a greater incidence with ALVESCO than with placebo.

Infections and Infestations: Oral candidiasis

Respiratory Disorders: Cough

Gastrointestinal Disorders: Dry mouth, nausea

General Disorders and Administrative Site Conditions: Chest discomfort

Respiratory, Thoracic, and Mediastinal Disorders: Dysphonia, dry throat

The fifth study was a 12-week clinical trial in asthma patients 12 years of age and older who previously required oral corticosteroids (average daily dose of oral prednisone of 12 mg/day), in which the effects of ALVESCO 320 mcg twice daily (n = 47) and 640 mcg twice daily (n = 49) were compared with placebo (n = 45) for the frequency of reported adverse reactions. The following adverse reactions occurred at an incidence of ≥ 3% in the ALVESCO-treated patients and were more frequent compared to placebo: sinusitis, hoarseness, oral candidiasis, influenza, pneumonia, nasopharyngitis, arthralgia, back pain, musculoskeletal chest pain, headache, urticaria, dizziness, gastroenteritis, face edema, fatigue, and conjunctivitis.

Long-Term Clinical Trials Experience

A total of 197 patients 12 years of age and older (82 males and 115 females) from one of the 12-week treatment placebo-controlled studies were re-randomized to ciclesonide 320 mcg twice daily and followed for one year. The safety profile from the one-year follow-up was similar to that seen in the 12- and 16-week treatment studies.

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