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ASMANEX HFA is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. ( 1.1 ) Important limitations: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 1.1 Treatment of Asthma ASMANEX ® HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use ASMANEX HFA is NOT indicated for the relief of acute bronchospasm.

• For oral inhalation only
• Treatment of asthma in patients 12 years of age and older: 2 inhalations twice daily of ASMANEX HFA 100 mcg or 200 mcg
• Starting dosage is based on prior asthma therapy
• Treatment of asthma in patients aged 5 to less than 12 years: 2 inhalations twice daily of ASMANEX HFA 50 mcg
• Administration Information Administer ASMANEX HFA only by the orally inhaled route [see Instructions for Use in the Patient Information leaflet ]
• 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
• Recommended Dosage Administer ASMANEX HFA as two inhalations twice daily every day (morning and evening) by the orally inhaled route
• Shake well prior to each inhalation

ASMANEX HFA is a pressurized metered dose inhaler (MDI) that is available in 2 strengths (100 mcg and 200 mcg) for adult and adolescent patients aged 12 years and older; and 1 strength (50 mcg) for pediatric patients aged 5 to less than 12 years. ASMANEX HFA 50 mcg delivers 50 mcg of mometasone furoate per actuation. ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation. …

• The safety and effectiveness of ASMANEX HFA have been established in patients 12 years of age and older in 2 clinical trials of 12 and 26 weeks in duration
• In the 2 clinical trials, 32 patients 12 to 17 years of age were treated with ASMANEX HFA
• No overall differences in effectiveness were observed between patients in this age group compared to those observed in patients 18 years of age and older. There were no obvious differences in the type or frequency of adverse reactions reported in this age group compared to patients 18 years of age and older. …

A total of 38 patients 65 years of age and older (3 of whom were 75 years and older) have been treated with ASMANEX HFA in 2 clinical trials of 12 and 26 weeks in duration. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. …

• Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use )
• Not for Acute Symptoms Advise patients that ASMANEX HFA is not indicated to relieve acute asthma symptoms, and extra doses should not be used for that purpose
• ASMANEX HFA is not a bronchodilator and should not be used to treat status asthmaticus or to relieve acute asthma symptoms
• Treat acute asthma symptoms with an inhaled, short-acting beta 2 -agonist such as albuterol
• Prescribe the patient with such medication and instruct the patient on how to use it [see Warnings and Precautions ]. …

• Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures
• Hypersensitivity to any of the ingredients of ASMANEX HFA
• Status Asthmaticus ASMANEX HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. …

In clinical trials, concurrent administration of ASMANEX HFA and other drugs, such as short-acting beta 2 -agonist and intranasal corticosteroids have not resulted in an increased frequency of adverse drug reactions. No formal drug interaction studies have been performed with ASMANEX HFA. Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 The main route of metabolism of corticosteroids, including mometasone furoate, is via CYP3A4. …

Deterioration of asthma and acute episodes: ASMANEX HFA should not be used for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.1 ) Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. After dosing, advise patients to rinse their mouth with water and spit out contents without swallowing. ( 5.2 ) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. …

Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.2) ] Immunosuppression [see Warnings and Precautions (5.3) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.5) ] Growth effects in pediatrics [see Warnings and Precautions (5.10) ] Glaucoma and cataracts [see Warnings and Precautions (5.11) ] 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. …

8.1 Pregnancy Risk Summary There are no randomized clinical studies of ASMANEX HFA in pregnant women. There are clinical considerations with the use of ASMANEX HFA in pregnant women [see Clinical Considerations ] . In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximatel …

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5) ] . Single oral doses up to 8000 mcg of mometasone furoate have been studied on adult subjects with no adverse reactions reported.

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. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.