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Asmanex

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Asmanex Twisthaler

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Effects

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans occurred in 195 of 3007 patients treated with ASMANEX TWISTHALER (mometasone furoate) . If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX TWISTHALER (mometasone furoate) therapy, but at times therapy with the ASMANEX TWISTHALER (mometasone furoate) may need to be interrupted. Advise patients to rinse the mouth after inhalation of ASMANEX TWISTHALER (mometasone furoate) .

Acute Asthma Episodes

ASMANEX TWISTHALER (mometasone furoate) is not a bronchodilator and is not indicated for rapid relief of bronchospasm or other acute episodes of asthma. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with ASMANEX TWISTHALER (mometasone furoate) . During such episodes, patients may require therapy with oral corticosteroids.

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including rash, pruritus, angioedema, and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER (mometasone furoate) . Discontinue ASMANEX TWISTHALER if such reactions occur [see CONTRAINDICATIONS and Post marketing Experience].

ASMANEX TWISTHALER (mometasone furoate) contains small amounts of lactose, which contains trace levels of milk proteins. In post-marketing experience with ASMANEX TWISTHALER (mometasone furoate) , anaphylactic reactions in patients with milk protein allergy have been reported [see CONTRAINDICATIONS and, Post-marketing experience].

Immunosuppression

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Transferring Patients from Systemic Corticosteroid Therapy

Particular care is needed for patients who are transferred from systemically active corticosteroids to ASMANEX TWISTHALER (mometasone furoate) because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although ASMANEX TWISTHALER may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity necessary for coping with these emergencies.

During periods of stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or severe asthma attack.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ASMANEX TWISTHALER (mometasone furoate) . Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during treatment with ASMANEX TWISTHALER [see DOSAGE AND ADMINISTRATION]. Lung function (FEV1 or PEFR), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to ASMANEX TWISTHALER (mometasone furoate) may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

Hypercorticism and Adrenal Suppression

ASMANEX TWISTHALER (mometasone furoate) 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 ASMANEX TWISTHALER (mometasone furoate) . Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly when ASMANEX TWISTHALER (mometasone furoate) is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ASMANEX TWISTHALER (mometasone furoate) should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma.

Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate. 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 corticosteroids) should be monitored and treated with established standards of care.

In a 2-year double-blind study in 103 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (baseline FEV1 85%88% predicted), treatment with ASMANEX TWISTHALER (mometasone furoate) 220 mcg twice daily resulted in significant reductions in lumbar spine (LS) BMD at the end of the treatment period compared to placebo. The mean change from baseline to endpoint in the lumbar spine BMD was -0.015 (-1.43%) for the ASMANEX TWISTHALER (mometasone furoate) group compared to 0.002 (0.25%) for the placebo group. In another 2-year double-blind study in 87 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (baseline FEV1 82%-83% predicted), treatment with ASMANEX TWISTHALER (mometasone furoate) 440 mcg twice daily demonstrated no statistically significant changes in lumbar spine BMD at the end of the treatment period compared to placebo. The mean change from baseline to endpoint in the lumbar spine BMD was -0.018 (-1.57%) for the ASMANEX TWISTHALER (mometasone furoate) group compared to -0.006 (-0.43%) for the placebo group.

Effect on Growth

Orally inhaled corticosteroids, including ASMANEX TWISTHALER (mometasone furoate) , may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ASMANEX TWISTHALER (mometasone furoate) routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX

TWISTHALER, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [see Use In Specific Populations].

Glaucoma and Cataracts

In clinical trials glaucoma, increased intraocular pressure, and cataracts have been reported in 8 of 3007 patients following the administration of ASMANEX TWISTHALER. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Paradoxical Bronchospasm

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

Patient Counseling Information

See FDA-Approved Patient Labeling

Oral Candidiasis

Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with ASMANEX TWISTHALER (mometasone furoate) therapy, but at times therapy with ASMANEX TWISTHALER (mometasone furoate) may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see WARNINGS AND PRECAUTIONS].

Acute Asthma Episodes

Patients should be advised that ASMANEX TWISTHALER (mometasone furoate) is not a bronchodilator and should not be used to treat status asthmaticus or to relieve acute asthma symptoms. Acute asthma symptoms should be treated with an inhaled, short-acting beta-2 agonist such as albuterol [see WARNINGS AND PRECAUTIONS].

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER (mometasone furoate) . Discontinue ASMANEX TWISTHALER if such reactions occur [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and Post marketing Experience].

ASMANEX TWISTHALER (mometasone furoate) contains small amounts of lactose, which contains trace levels of milk proteins. In post-marketing experience with ASMANEX TWISTHALER (mometasone furoate) , anaphylactic reactions in patients with milk protein allergy have been reported [see CONTRAINDICATIONSand Post-marketing experience].

Immunosuppression

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex [see WARNINGS AND PRECAUTIONS].

Hypercorticism and Adrenal Suppression

Patients should be advised that ASMANEX TWISTHALER (mometasone furoate) may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to ASMANEX TWISTHALER (mometasone furoate) [see WARNINGS AND PRECAUTIONS].

Reduction in Bone Mineral Density

Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk and should be monitored and, where appropriate, be treated for this condition [see WARNINGS AND PRECAUTIONS].

Reduced Growth Velocity

Patients should be informed that orally inhaled corticosteroids, including mometasone furoate inhalation powder, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see WARNINGS AND PRECAUTIONS].

Use Daily for Best Effect

Patients should be advised to use ASMANEX TWISTHALER (mometasone furoate) at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. If symptoms do not improve in that time frame or if the condition worsens, patients should be instructed to contact their physician.

Instructions for Use

Patients should be instructed to record the date of pouch opening on the cap label, and discard the inhaler 45 days after opening the foil pouch or when the dose counter reads “00” and the final dose has been inhaled, whichever comes first. The inhaler should be held upright while removing the cap. The medication should be taken as directed, breathing rapidly and deeply, and patients should not breathe out through the inhaler. The mouthpiece should be wiped dry and the cap replaced immediately following each inhalation, rotated fully until the click is heard. Rinsing of mouth after inhalation is advised. Patients should store the unit as instructed. The dose counter displays the doses remaining. When the dose counter indicates zero, the cap will lock and the unit must be discarded. Patients should be advised that if the dose counter is not working correctly, the unit should not be used and it should be brought to their physician or pharmacist [see FDA-Approved Patient Labeling-Patient's Instructions for Use].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year carcinogenicity study in Sprague Dawley® rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 8 times the maximum recommended daily inhalation dose in adults on an AUC basis and 2 times the maximum recommended daily inhalation dose in pediatric patients based on an mcg/m² basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 10 times the maximum recommended daily inhalation dose in adults on an AUC basis and 2 times the maximum recommended daily inhalation dose in pediatric patients based on an mcg/m² basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not have this effect in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (approximately 6 times the maximum recommended daily inhalation dose in adults on an AUC basis).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of ASMANEX TWISTHALER (mometasone furoate) use in pregnant women. Animal reproduction studies in mice, rats, and rabbits revealed evidence of teratogenicity. Asthma is a serious and potentially life-threatening condition. Poorly controlled asthma during pregnancy is associated with adverse outcomes for mother and fetus. ASMANEX TWISTHALER (mometasone furoate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

There is a natural increase in corticosteroid production during pregnancy; therefore most women require a lower exogenous corticosteroid dose and may not need corticosteroid treatment during pregnancy. Infants born to mothers taking substantial oral corticosteroid doses during pregnancy should be monitored for signs of hypoadrenalism.

When administered to pregnant mice, rats, and rabbits, mometasone furoate increased fetal malformations and decreased fetal growth (measured by lower fetal weights and/or delayed ossification). Dystocia and related complications were also observed when mometasone furoate was administered to rats late in gestation. However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans.

In a mouse reproduction study, subcutaneous mometasone furoate produced cleft palate at approximately one-third of the maximum recommended daily human dose (MRHD) for adults on an mcg/m² basis and decreased fetal survival at approximately 1 time the MRHD. No toxicity was observed at approximately one-tenth of the MRHD.

In a rat reproduction study, mometasone furoate produced umbilical hernia at topical dermal doses approximately 6 times the MRHD and delays in ossification at approximately 3 times the MRHD.

In another study, rats received subcutaneous doses of mometasone throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose that was approximately 6 times the MRHD for adults on an area under the curve (AUC) basis. Similar effects were not observed at approximately 3 times the MRHD.

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical dermal doses approximately 3 times the maximum recommended daily inhalation dose in adults on an mcg/m² basis. In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at a dose less than the MRHD for adults based on AUC. At a dose approximately 2 times the MRHD in adults based on AUC, most litters were aborted or resorbed [see Nonclinical Toxicology].

Nursing Mothers

Systemic absorption of a single inhaled 400 mcg mometasone dose was less than 1%. It is not known if mometasone furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when ASMANEX TWISTHALER (mometasone furoate) is administered to nursing women.

Pediatric Use

The safety and effectiveness of ASMANEX TWISTHALER (mometasone furoate) have been established in children 4 years of age and older. Use of ASMANEX TWISTHALER (mometasone furoate) in children 12 years of age and older is supported by evidence from adequate and well-controlled clinical trials in this patient population [see Clinical Studies and ADVERSE REACTIONS].

Use of ASMANEX TWISTHALER (mometasone furoate) in pediatric patients 4 to 11 years of age is supported by evidence from adequate and well-controlled clinical trials of 12 weeks duration in 630 patients 4 to 11 years of age receiving ASMANEX TWISTHALER (mometasone furoate) and one 52-week safety trial in 152 patients [see Clinical Studies and ADVERSE REACTIONS].

Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth in pediatric patients. In these studies, the mean reduction in growth velocity was approximately 1 cm per year (range: 0.3-1.8 per year) and appears to depend upon dose and duration of exposure. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. The growth of children and adolescents (4 years of age and older) receiving orally inhaled corticosteroids, including ASMANEX TWISTHALER (mometasone furoate) , should be monitored routinely (e.g., via stadiometry).

A 52-week, placebo-controlled, parallel-group study was conducted to assess the potential growth effects of ASMANEX TWISTHALER (mometasone furoate) in 187 prepubescent children (131 males and 56 females) 4 to 9 years of age with asthma who were previously maintained on an inhaled beta-agonist. Treatment groups included ASMANEX TWISTHALER (mometasone furoate) 110 mcg twice daily (n=44), 220 mcg once daily in the morning (n=50), 110 mcg once daily in the morning (n=48), and placebo (n=45). For each patient, an average growth rate was determined using an individual regression approach. The mean growth rates, expressed as least-squares mean in cm per year, for ASMANEX TWISTHALER (mometasone furoate) 110 mcg twice daily, 220 mcg once daily in the morning, 110 mcg once daily in the morning, and placebo were 5.34, 5.93, 6.15, and 6.44, respectively. The differences from placebo and the corresponding 2-sided 95% CI of growth rates for ASMANEX TWISTHALER (mometasone furoate) 110 mcg twice daily, 220 mcg once daily in the morning, and 110 mcg once daily in the morning were -1.11 (95% CI: -2.34, 0.12), -0.51 (95% CI: -1.69, 0.67), and 0.30 (95% CI: -1.48, 0.89), respectively.

The potential growth effects of prolonged treatment with orally inhaled corticosteroids should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX TWISTHALER (mometasone furoate) , each patient should be titrated to his/her lowest effective dose.

Geriatric Use

A total of 175 patients 65 years of age and over (23 of whom were 75 years of age and older) have been treated with ASMANEX TWISTHALER (mometasone furoate) in controlled clinical trials. No overall differences in safety or effectiveness were observed between these and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment

Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see CLINICAL PHARMACOLOGY].

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

Warnings
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