ASMANEX® HFA (mometasone furoate) Inhalation Aerosol

ASMANEX® HFA is for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

ASMANEX HFA is NOT indicated for the relief of acute bronchospasm or in patients less than 12 years old.

ASMANEX HFA is available in 2 dose strengths, 100 mcg and 200 mcg.

Selected Safety Information About ASMANEX® HFA (mometasone furoate) Inhalation Aerosol

ASMANEX HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

ASMANEX HFA is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in ASMANEX HFA.

ASMANEX HFA is not indicated for the relief of acute symptoms, ie, as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not ASMANEX HFA, should be used to relieve acute symptoms such as shortness of breath.

Oropharyngeal candidiasis may occur. If candidiasis develops, it should be treated with appropriate antifungal therapy, but at times, therapy with ASMANEX HFA may need to be interrupted. Advise patients to rinse the mouth after inhalation.

Chickenpox and measles 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.

CAUTION: Adrenal insufficiency may occur when transferring patients from systemic steroids (see WARNINGS and PRECAUTIONS in full Prescribing Information). To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX HFA, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms.

Caution should be exercised when considering the coadministration of ASMANEX HFA with ketoconazole and other known strong cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) inhibitors because adverse effects related to increased systemic exposure to mometasone furoate may occur.

Orally inhaled corticosteroids, including ASMANEX HFA, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ASMANEX HFA routinely (eg, via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX HFA, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms.

Clinical trials have shown that inhaled corticosteroids may cause a reduction in growth in pediatric patients. In studies, the mean reduction in growth velocity for patients was approximately 1 cm per year (range, 0.3−1.8 per year) and appears to depend upon dose and duration of exposure. The long-term effects of the reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The growth of children and adolescents receiving orally inhaled corticosteroids, including ASMANEX HFA, should be monitored routinely.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of ASMANEX HFA. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

The most common adverse events with ASMANEX HFA reported in ≥3% of patients 12 years and older in 2 clinical trials were: nasopharyngitis, headache, sinusitis, bronchitis, and influenza.

Before prescribing ASMANEX HFA, please read the accompanying Prescribing Information. The Patient Information also is available.

RESP-1076949-0004 03/15

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Selected Safety Information About ASMANEX® HFA (mometasone furoate) Inhalation Aerosol

ASMANEX HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

ASMANEX HFA is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in ASMANEX HFA.

ASMANEX HFA is not indicated for the relief of acute symptoms, ie, as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not ASMANEX HFA, should be used to relieve acute symptoms such as shortness of breath.

Oropharyngeal candidiasis may occur. If candidiasis develops, it should be treated with appropriate antifungal therapy, but at times, therapy with ASMANEX HFA may need to be interrupted. Advise patients to rinse the mouth after inhalation.

Chickenpox and measles 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.

CAUTION: Adrenal insufficiency may occur when transferring patients from systemic steroids (see WARNINGS and PRECAUTIONS in full Prescribing Information). To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX HFA, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms.

Caution should be exercised when considering the coadministration of ASMANEX HFA with ketoconazole and other known strong cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) inhibitors because adverse effects related to increased systemic exposure to mometasone furoate may occur.

Orally inhaled corticosteroids, including ASMANEX HFA, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ASMANEX HFA routinely (eg, via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX HFA, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms.

Clinical trials have shown that inhaled corticosteroids may cause a reduction in growth in pediatric patients. In studies, the mean reduction in growth velocity for patients was approximately 1 cm per year (range, 0.3−1.8 per year) and appears to depend upon dose and duration of exposure. The long-term effects of the reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The growth of children and adolescents receiving orally inhaled corticosteroids, including ASMANEX HFA, should be monitored routinely.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of ASMANEX HFA. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

The most common adverse events with ASMANEX HFA reported in ≥3% of patients 12 years and older in 2 clinical trials were: nasopharyngitis, headache, sinusitis, bronchitis, and influenza.

Before prescribing ASMANEX HFA, please read the accompanying Prescribing Information. The Patient Information also is available.