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Asmanex Twisthaler

Side Effects
Interactions

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Studies Experience

The safety data described below reflect exposure to ASMANEX TWISTHALER (mometasone furoate) in 2380 patients with asthma exposed for 8 to 12 weeks and 627 patients with asthma exposed for 1 year in a total of 17 clinical trials.

In adult and adolescent patients 12 years of age and older, ASMANEX TWISTHALER (mometasone furoate) was studied in 10 placebo-controlled clinical trials of 8 to 12 weeks duration with a total of 1750 patients receiving ASMANEX TWISTHALER (mometasone furoate) . There were also 3 trials with a total of 475 patients receiving ASMANEX TWISTHALER (mometasone furoate) for 1 year. In the 8- to 12-week clinical trials, the population was 12 to 83 years of age, 38% males and 62% females, and 83% Caucasian, 8% black, 6% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER (mometasone furoate) 110 mcg twice daily (n=133), 220 mcg once daily in the morning (n=209), 220 mcg once daily in the evening (n=232), 220 mcg twice daily (n=433), 440 mcg once daily in the morning (n=419), 440 mcg once daily in the evening (n=250), or 440 mcg twice daily (n=74). In 3 long-term safety trials (two 9-month extensions of efficacy trials and one 52-week active-controlled safety trial), 475 patients with asthma (12 - 83 years of age, 44% males, 56% females, 87% Caucasian, 8% black, 4% Hispanic, and 1% other race/ethnicity) received various doses of ASMANEX TWISTHALER (mometasone furoate) for 1 year.

In pediatric patients 4 to 11 years of age, ASMANEX TWISTHALER (mometasone furoate) was studied in 3 placebo-controlled clinical trials of 12 weeks duration with a total of 630 patients receiving ASMANEX TWISTHALER (mometasone furoate) and a 52-week, active-controlled safety trial with a total of 152 patients receiving ASMANEX TWISTHALER (mometasone furoate) . In the 12-week clinical trials, the population was 4 to 11 years of age, 63% males and 37% females, and 67% Caucasian, 13% black, 17% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER (mometasone furoate) 110 mcg once daily in the evening (n=98), 110 mcg once daily in the morning (n=181), 110 mcg twice daily (n=179), or 220 mcg once daily in the morning (n=172). In the long-term active-controlled safety trial (n=152), patients with asthma (4 to 11 years of age, 60% males and 40% females, 84% Caucasian, 11% Black, and 5% Hispanic) received ASMANEX TWISTHALER (mometasone furoate) 110 mcg twice daily or 220 mcg once daily in the morning for 52 weeks.

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 Adolescents 12 Years of Age and Older

The safety results of the 10 trials that were 8 to 12 weeks in duration were pooled because patients with asthma in these studies were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results of the one 12-week clinical trial in patients with asthma previously treated with oral corticosteroids are presented separately.

In the pooled 8- to 12-week clinical trials, adverse reactions were reported in 70% of patients treated with ASMANEX TWISTHALER (mometasone furoate) (n=1750) compared to 65% of patients taking placebo (n=720). Table 2 displays the common adverse reactions ( ≥ 3% in any patient group receiving ASMANEX TWISTHALER (mometasone furoate) ) that occurred more frequently in patients treated with ASMANEX TWISTHALER (mometasone furoate) compared to patients treated with placebo.

TABLE 2: Adverse Reactions with ≥ 3% Incidence in 10 Controlled Clinical Trials with ASMANEX TWISTHALER (mometasone furoate) in Patients 12 Years of Age and Older Previously on Bronchodilators and/or Inhaled Corticosteroids

Adverse Reaction (%) of Patients
ASMANEX TWISTHALER Placebo
(n=720)
220 mcg
twice daily
(n=433)
440 mcg
once daily
(n=497)
220 mcg
once daily in the evening
(n=232)
Headache 22 17 20 20
Allergic Rhinitis 15 11 14 13
Pharyngitis 11 8 13 7
Upper Respiratory Infection 10 8 15 7
Sinusitis 6 6 5 5
Candidiasis, oral 6 4 4 2
Dysmenorrhea* 9 4 4 4
Musculoskeletal Pain 8 4 4 5
Back Pain 6 3 3 4
Dyspepsia 5 3 3 3
Myalgia 3 2 3 2
Abdominal Pain 3 2 3 2
Nausea 3 1 3 2
Average Duration of Exposure (Days) 81 70 80 62
* Percentages are based on the number of female patients.

The following other adverse reactions occurred in these clinical trials with an incidence of at least 1% but less than 3% and were more common on ASMANEX TWISTHALER therapy than on placebo:

Body as a Whole: fatigue, flu-like symptoms, pain

Gastrointestinal: gastroenteritis, vomiting, anorexia

Hearing, Vestibular: earache

Resistance Mechanism: infection

Respiratory: dysphonia, epistaxis, nasal irritation, respiratory disorder, throat dry

In the 12-week trial in adult asthmatics who previously required oral corticosteroids, the effects of ASMANEX TWISTHALER (mometasone furoate) therapy administered as two 220mcg inhalations twice daily (n=46) were compared with those of placebo (n=43). Adverse reactions, whether considered drug-related or not by the investigators, reported in more than 3 patients in the ASMANEX TWISTHALER (mometasone furoate) treatment group, and which occurred more frequently than in placebo were (ASMANEX TWISTHALER (mometasone furoate) % vs. placebo %): musculoskeletal pain (22% vs. 14%), oral candidiasis (22% vs. 9%), sinusitis (22% vs. 19%), allergic rhinitis (20% vs. 5%), upper respiratory infection (15% vs. 14%), arthralgia (13% vs. 7%), fatigue (13% vs. 2%), depression (11% vs. 0%), and sinus congestion (9% vs. 0%). In considering these data, an increased duration of exposure for patients on ASMANEX TWISTHALER (mometasone furoate) treatment (77 days vs. 58 days on placebo) should be taken into account.

Long-Term Clinical Trials Experience - 12 Years of Age and Older

In 3 long-term safety trials, 475 patients with asthma 12 years of age and older were treated with ASMANEX TWISTHALER (mometasone furoate) 220 mcg twice daily (n=60), 220 mcg once daily in the morning (n=41), 220 mcg once daily in the evening (n=40), 440 mcg once daily in the morning (n=44), 440 once daily in the evening (n=41), 440 mcg twice daily (n=62), 880 mcg once daily (n=59), or at variable doses (n=128) for 52 weeks. The safety profile of ASMANEX TWISTHALER (mometasone furoate) in the 52-week trials was similar to the findings in the 8- to 12-week clinical trials. In patients previously on inhaled corticosteroids, cataracts were reported in 3 patients (0.9%) treated with ASMANEX TWISTHALER (mometasone furoate) , compared to 1 patient (1.7%) treated with the active comparator medication. Increased ocular pressure at the end of the study was observed in 2 patients, both on ASMANEX TWISTHALER (mometasone furoate) 880 mcg once daily in the morning. Oral candidiasis, dysphonia, and dysmenorrhea were seen at a higher frequency with long-term administration than in the 8- to 12-week trials.

Pediatric Patients 4 to 11 Years of Age

In the three 12-week clinical trials in pediatric patients 4 to 11 years of age, patients with asthma were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results from 1 trial are described in Table 3 for ASMANEX TWISTHALER (mometasone furoate) 110 mcg once daily in the evening. The safety results from the other 2 trials showed similar findings.

Overall adverse reactions were reported with approximately the same frequency by patients treated with ASMANEX TWISTHALER (mometasone furoate) and those receiving placebo. Table 3 displays the common adverse reactions ( ≥ 2% in any patient group receiving ASMANEX TWISTHALER (mometasone furoate) ) that occurred more frequently in patients 4 to 11 years of age treated with ASMANEX TWISTHALER (mometasone furoate) compared with placebo-treated patients.

TABLE 3: Adverse Reactions with ≥ 2% Incidence in a 12-Week Study with ASMANEX TWISTHALER (mometasone furoate) in Patients 4 to 11 Years of Age Previously on Bronchodilators and/or Inhaled Corticosteroids

Adverse Reaction (%) of Patients
ASMANEX TWISTHALER
110 mcg once
daily in the
evening (n=98)
Placebo
(n=99)
Fever 7 5
Allergic Rhinitis 4 3
Abdominal Pain 6 2
Vomiting 3 2
Urinary Tract Infection 2 1
Bruise 2 0
Average Duration of Exposure (Days) 72 68

Long-Term Clinical Trials Experience in Children 4 to 11 Years of Age

In a 52-week, active-controlled, long-term safety trial, 152 patients with asthma 4 to 11 years of age were treated with ASMANEX TWISTHALER (mometasone furoate) 110 mcg twice daily (n=74) or 220 mcg once daily (n=78). The safety profile for ASMANEX TWISTHALER (mometasone furoate) in the 52-week trial was similar to the findings in the 12-week clinical trials.

Post marketing Experience

The following adverse reactions have been reported during post-approval use of ASMANEX TWISTHALER (mometasone furoate) . Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction. [see WARNINGS AND PRECAUTIONS and CONTRAINDICATIONS]

Respiratory, Thoracic and Mediastinal Disorders: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.

Read the Asmanex Twisthaler (mometasone furoate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

In clinical studies, the concurrent administration of ASMANEX TWISTHALER (mometasone furoate) and other drugs commonly used in the treatment of asthma was not associated with any unusual adverse reactions.

Inhibitors of Cytochrome P450 3A4

Ketoconazole, a strong inhibitor of cytochrome P450 3A4, may increase plasma levels of mometasone furoate during concomitant dosing [see CLINICAL PHARMACOLOGY].

Read the Asmanex Twisthaler Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/14/2010
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
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Asmanex Twisthaler - User Reviews

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