ASMANEX HFA — available in 3 dosage strengths:
| Recommended dosage of ASMANEX HFA in pediatric patients aged 5 to less than 12 years | Maximum daily dosage |
|---|---|
| Morning: 2 inhalations; 50 mcg per inhalation Evening: 2 inhalations; 50 mcg per inhalation | 200 mcg |
-OR-
| Recommended dosage of ASMANEX HFA in adult and adolescent patients aged 12 years and older |
| Morning: 2 inhalations; 100 mcg per inhalation Evening: 2 inhalations; 100 mcg per inhalation |
| – OR – |
| Morning: 2 inhalations; 200 mcg per inhalation Evening: 2 inhalations; 200 mcg per inhalation |
For patients 12 years of age and older, the starting dosage is based on previous asthma therapy and disease severity, including considerations of the patients’ current control of asthma symptoms and risk of future exacerbations. The recommended starting dosage for patients 12 years of age and older who are not on an inhaled corticosteroid is ASMANEX HFA 100 mcg, 2 inhalations twice daily. It is recommended that patients currently receiving chronic oral corticosteroid therapy (e.g., prednisone) begin with ASMANEX HFA 200 mcg (2 inhalations twice daily). For patients who do not respond adequately to the initial dosage after 2 weeks of therapy, increasing the dosage may provide additional asthma control. The maximum daily recommended dose is two inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day).
After asthma stability has been achieved, it may be desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.
If a dosage regimen of ASMANEX HFA fails to provide adequate control of asthma, re-evaluate the therapeutic regimen and consider additional therapeutic options, e.g., replacing the current strength of ASMANEX HFA with a higher strength, initiating an inhaled corticosteroid and long-acting beta2-agonist combination product, or initiating oral corticosteroids.
Administer ASMANEX HFA only by the orally inhaled route. After each dose, advise patients to rinse their mouth with water and, without swallowing, spit out the contents to help reduce the risk of oropharyngeal candidiasis.
Remove the cap from the mouthpiece of the actuator before using ASMANEX HFA.
Prime ASMANEX HFA before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.
Only use the ASMANEX HFA canister with the ASMANEX HFA actuator. Do not use the ASMANEX HFA actuator with any other inhalation drug product. Do not use actuators from other products with the ASMANEX HFA canister.
Abbreviation: HFA, hydrofluoroalkane.
ASMANEX HFA is for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.
ASMANEX HFA is NOT indicated for the relief of acute bronchospasm or in patients less than 5 years old.
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 with water and spit out contents without swallowing after each dose (2 inhalations) to help reduce the risk.
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. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX HFA long term.
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. Overall, the safety profile for patients aged 5 to less than 12 years is similar to that observed in patients aged 12 years and older.
Before prescribing ASMANEX® HFA (mometasone furoate) Inhalation Aerosol, please read the accompanying Prescribing Information. The Patient Information also is available.
