Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ASMANEX HFA is available in three strengths and supplied in the following package size (TABLE 3): TABLE 3 Package NDC Strength Identifier (Color Band) Included on the outer carton, actuator, and canister labels. ASMANEX HFA 50 mcg 120 metered actuations 78206-111-01 Orange ASMANEX HFA 100 mcg 120 metered actuations 78206-112-01 Green ASMANEX HFA 200 mcg 120 metered actuations 78206-113-01 Blue Each strength is supplied as a pressurized aluminum canister that has a blue plastic actuator integrated with a dose counter and a pink dust cap. Each canister has a net fill weight of 13 grams. Each inhaler is placed into a carton. Each carton contains 1 inhaler. Initially the dose counter will display "124" actuations. After the initial priming with 4 actuations, the dose counter will read "120" and the inhaler is now ready for use. 16.2 Storage and Handling 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. Do not remove the canister from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Discard the inhaler when the labeled number of actuations has been used (the dose counter will read "0"). Store at controlled room temperature 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. After priming, store the inhaler with the mouthpiece down or in a horizontal position. For best results, keep the canister at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.; PRINCIPAL DISPLAY PANEL - 100 mcg Canister Carton NDC 78206-112-01 Asmanex ® HFA (mometasone furoate) Inhalation Aerosol 100 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g PRINCIPAL DISPLAY PANEL - 100 mcg Canister Carton; PRINCIPAL DISPLAY PANEL - 200 mcg Canister Carton NDC 78206-113-01 Asmanex ® HFA (mometasone furoate) Inhalation Aerosol 200 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g PRINCIPAL DISPLAY PANEL - 200 mcg Canister Carton; PRINCIPAL DISPLAY PANEL - 50 mcg Canister Carton NDC 78206-111-01 Asmanex ® HFA (mometasone furoate) Inhalation Aerosol 50 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g PRINCIPAL DISPLAY PANEL - 50 mcg Canister Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ASMANEX HFA is available in three strengths and supplied in the following package size (TABLE 3): TABLE 3 Package NDC Strength Identifier (Color Band) Included on the outer carton, actuator, and canister labels. ASMANEX HFA 50 mcg 120 metered actuations 78206-111-01 Orange ASMANEX HFA 100 mcg 120 metered actuations 78206-112-01 Green ASMANEX HFA 200 mcg 120 metered actuations 78206-113-01 Blue Each strength is supplied as a pressurized aluminum canister that has a blue plastic actuator integrated with a dose counter and a pink dust cap. Each canister has a net fill weight of 13 grams. Each inhaler is placed into a carton. Each carton contains 1 inhaler. Initially the dose counter will display "124" actuations. After the initial priming with 4 actuations, the dose counter will read "120" and the inhaler is now ready for use. 16.2 Storage and Handling 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. Do not remove the canister from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Discard the inhaler when the labeled number of actuations has been used (the dose counter will read "0"). Store at controlled room temperature 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. After priming, store the inhaler with the mouthpiece down or in a horizontal position. For best results, keep the canister at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.
- PRINCIPAL DISPLAY PANEL - 100 mcg Canister Carton NDC 78206-112-01 Asmanex ® HFA (mometasone furoate) Inhalation Aerosol 100 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g PRINCIPAL DISPLAY PANEL - 100 mcg Canister Carton
- PRINCIPAL DISPLAY PANEL - 200 mcg Canister Carton NDC 78206-113-01 Asmanex ® HFA (mometasone furoate) Inhalation Aerosol 200 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g PRINCIPAL DISPLAY PANEL - 200 mcg Canister Carton
- PRINCIPAL DISPLAY PANEL - 50 mcg Canister Carton NDC 78206-111-01 Asmanex ® HFA (mometasone furoate) Inhalation Aerosol 50 mcg per actuation For oral inhalation only Asmanex HFA canister to be used with Asmanex HFA actuator only. SHAKE WELL BEFORE USING. Rx only 120 Metered Actuations Net Wt. 13g PRINCIPAL DISPLAY PANEL - 50 mcg Canister Carton
Overview
ASMANEX HFA is a metered dose inhaler for oral inhalation only, consisting of 50 mcg, 100 mcg, or 200 mcg of mometasone furoate per actuation. Mometasone furoate, the active component of ASMANEX HFA, is a corticosteroid having the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16 (alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) with the following chemical structure: Mometasone furoate is a white powder with an empirical formula of C 27 H 30 Cl 2 O 6 , and molecular weight 521.44. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone. ASMANEX HFA 50 mcg, 100 mcg, and 200 mcg are each formulated as a hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane) propelled pressurized metered dose inhaler containing sufficient amount of drug for 120 actuations [see How Supplied/Storage and Handling (16) ] . After priming, each actuation of the inhaler delivers 60, 115, or 225 mcg of mometasone furoate in 69.6 mg of suspension from the valve and delivers 50, 100, or 200 mcg of mometasone furoate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. ASMANEX HFA also contains ethanol as a cosolvent and oleic acid as a surfactant. ASMANEX HFA should be primed 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. Chemical Structure
Indications & Usage
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.
Dosage & Administration
For oral inhalation only. ( 2.1 ) 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. ( 2.2 ) Treatment of asthma in patients aged 5 to less than 12 years: 2 inhalations twice daily of ASMANEX HFA 50 mcg. ( 2.2 ) 2.1 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. 2.2 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. If symptoms arise between doses, use an inhaled short-acting beta 2 -agonist for immediate relief. The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may experience a variable time to onset and degree of symptom relief. Adult and Adolescent Patients Aged 12 Years and Older For patients 12 years of age and older, the dosage is either 2 inhalations twice daily of ASMANEX HFA 100 mcg or 200 mcg. 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 beta 2 -agonist combination product, or initiating oral corticosteroids. Pediatric Patients Aged 5 to Less Than 12 Years For patients aged 5 to less than 12 years, the dosage is 2 inhalations of ASMANEX HFA 50 mcg twice daily. The maximum daily dosage is 200 mcg.
Warnings & Precautions
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. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections. ( 5.3 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Wean patients slowly from systemic corticosteroids if transferring to ASMANEX HFA. ( 5.4 ) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ASMANEX HFA slowly. ( 5.5 ) Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects. Exercise caution when used with ASMANEX HFA. ( 5.6 ) Paradoxical bronchospasm: Discontinue ASMANEX HFA and institute alternative therapy if paradoxical bronchospasm occurs. ( 5.7 ) Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, such as urticaria, flushing, allergic dermatitis, bronchospasm, rash, pruritus, angioedema, and anaphylactic reaction may occur. Discontinue ASMANEX HFA if such reactions occur. ( 5.8 ) Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. ( 5.9 ) Effects on growth: Monitor growth of pediatric patients. ( 5.10 ) Glaucoma and cataracts: Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX HFA long term. ( 5.11 ) 5.1 Deterioration of Asthma and Acute Episodes ASMANEX HFA is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta 2 -agonist, not ASMANEX HFA, should be used to relieve acute symptoms such as shortness of breath. When prescribing ASMANEX HFA, the physician must also provide the patient with an inhaled, short-acting beta 2 -agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and evening) use of ASMANEX HFA. 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 HFA. During such episodes, patients may require therapy with oral corticosteroids. 5.2 Local Effects In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans have occurred in patients treated with ASMANEX HFA. If oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX HFA therapy, but at times therapy with ASMANEX HFA may need to be interrupted. To reduce the risk of oropharyngeal candidiasis, after dosing with ASMANEX HFA, advise patients to rinse their mouth with water and spit out the contents without swallowing. 5.3 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) or pooled intravenous immunoglobulin (IVIG) 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. 5.4 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed for patients who are transferred from systemically active corticosteroids to ASMANEX HFA 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 HFA 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 or other systemic corticosteroids should be weaned slowly from oral or other systemic corticosteroid use after transferring to ASMANEX HFA. Lung function (FEV 1 or PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral or other systemic 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 HFA 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. 5.5 Hypercorticism and Adrenal Suppression ASMANEX HFA will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since mometasone furoate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of ASMANEX HFA in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with ASMANEX HFA should be observed carefully for any evidence of systemic corticosteroid effects. 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 (including adrenal crisis) may appear in a small number of patients, particularly when mometasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ASMANEX HFA should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms. 5.6 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of ASMANEX HFA with ketoconazole, and other known strong cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to mometasone furoate may occur [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. 5.7 Paradoxical Bronchospasm and Upper Airway Symptoms ASMANEX HFA may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs, it should be treated immediately with an inhaled, short-acting bronchodilator. ASMANEX HFA should be discontinued immediately and alternative therapy instituted. 5.8 Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions such as urticaria, flushing, allergic dermatitis, and bronchospasm, may occur after administration of ASMANEX HFA. Discontinue ASMANEX HFA if such reactions occur [see Contraindications (4.2) ]. The following additional hypersensitivity reactions, such as rash, pruritus, angioedema, and anaphylactic reaction, have been reported after administration of mometasone furoate dry powder inhaler (DPI) [see Adverse Reactions (6.2) ]. 5.9 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, such as fracture, 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 FEV 1 85%-88% predicted), treatment with mometasone furoate dry powder inhaler 200 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 mometasone furoate dry powder inhaler 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 FEV 1 82%-83% predicted), treatment with mometasone furoate dry powder inhaler 400 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 mometasone furoate group compared to -0.006 (-0.43%) for the placebo group. 5.10 Effect on Growth 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 (e.g., 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 [see Use in Specific Populations (8.4) ] . 5.11 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term administration of inhaled corticosteroids, including mometasone furoate. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX HFA long term [see Adverse Reactions (6) ] .
Contraindications
Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4.1 ) Hypersensitivity to any of the ingredients of ASMANEX HFA. ( 4.2 ) 4.1 Status Asthmaticus ASMANEX HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. 4.2 Hypersensitivity ASMANEX HFA is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in ASMANEX HFA [see Warnings and Precautions (5.8) ] .
Adverse Reactions
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. Most common adverse reactions (reported in greater than or equal to 3% of patients) included: nasopharyngitis, headache, sinusitis, bronchitis, and influenza. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adult and Adolescent Patients Aged 12 Years and Older The safety of ASMANEX HFA was evaluated in 2 randomized placebo and active-controlled trials of 12 and 26 weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program, which enrolled 1509 patients with persistent asthma. Patient ages ranged from 12 to 84 years of age, 41% were male and 59% female, 73% were Caucasian and 27% non-Caucasian. Of the total population enrolled in the 2 trials, 432 patients received two inhalations twice daily of either ASMANEX HFA, 100 mcg or 200 mcg/actuation. In the 26-week trial (Trial 1) 192 patients received two inhalations twice daily of ASMANEX HFA 100 mcg/actuation and 196 patients received placebo. In the 12 week trial (Trial 2) 240 patients received two inhalations twice daily of ASMANEX HFA 200 mcg/actuation and 233 and 255 patients received mometasone furoate and formoterol fumarate 100 mcg/5 mcg and 200 mcg/5 mcg/actuation combination products, respectively, as comparators. In these trials, the proportion of patients who discontinued study treatment early due to adverse reactions was 3% and 2% for ASMANEX HFA 100 and 200 mcg treated patients, respectively, and 4% for placebo-treated patients. Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in ASMANEX HFA-treated patients included colitis ulcerative, colonic polyp, chest pain, gastroenteritis, endometriosis, asthma, and hemoptysis; all events occurred at rates less than 1%. The incidence of treatment emergent adverse events associated with ASMANEX HFA are shown in Tables 1 and 2. These are based upon data from each of the 2 clinical trials of 12 or 26 weeks in duration in patients 12 years and older treated with two inhalations twice daily of ASMANEX HFA (100 mcg or 200 mcg), mometasone furoate/formoterol fumarate (100 mcg/5 mcg or 200 mcg/5 mcg), or placebo. TABLE 1: Trial 1: Treatment-Emergent Adverse Events Occurring at an Incidence of ≥3% and More Commonly than Placebo Over 26 Weeks ASMANEX HFA 100 mcg N=192 n (%) Placebo N=196 n (%) Nasopharyngitis 15 (8) 7 (4) Headache 10 (5) 7 (4) Influenza 7 (4) 5 (3) Sinusitis 6 (3) 2 (1) TABLE 2: Trial 2: Treatment-Emergent Adverse Events Occurring at an Incidence of ≥3% Over 12 Weeks ASMANEX HFA 200 mcg N=240 n (%) MF/F MF/F = mometasone furoate/formoterol fumarate. 100/5 mcg N=233 n (%) MF/F 200/5 mcg N=255 n (%) Nasopharyngitis 13 (5) 8 (3) 12 (5) Headache 8 (3) 10 (4) 5 (2) Bronchitis 6 (3) 2 (1) 7 (3) Oral candidiasis has been reported in clinical trials at an incidence of 0.5% in patients using ASMANEX HFA 100 mcg, 0.8% in patients using ASMANEX HFA 200 mcg and 0.5% in the placebo group. Pediatric Patients Aged 5 to Less Than 12 Years The safety profile for ASMANEX HFA 50 mcg, 2 inhalations twice daily, is based on two clinical trials consisting of a total of 759 patients aged 5 to less than 12 years with persistent asthma. The first trial was a placebo-controlled trial comparing ASMANEX HFA 50 mcg (administered as 2 inhalations, twice daily) to 2 other dosage strengths of mometasone furoate MDI (25 mcg or 100 mcg, each administered as two inhalations, twice daily) as well as mometasone furoate DPI 100 mcg, administered as one evening inhalation. The second trial compared ASMANEX HFA 50 mcg to the combination of mometasone furoate and formoterol fumarate 50 mcg/5 mcg, each administered by MDI as two inhalations, twice daily. Overall, the safety profile for pediatric patients is similar to that observed in patients aged 12 years and older. 6.2 Postmarketing Experience There are no postmarketing adverse experiences reported to date with ASMANEX HFA. However, the postmarketing safety experience with mometasone furoate dry powder inhaler is relevant to ASMANEX HFA since they contain the same active ingredient. The following adverse reactions have been reported during post-approval use of mometasone furoate dry powder inhaler. Because these reactions 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. Eye Disorders: Vision blurred [see Warnings and Precautions (5.11) ] . Immune System Disorders: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction [see Contraindications (4.2) and Warnings and Precautions (5.8) ] . Respiratory, Thoracic and Mediastinal Disorders: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.
Drug Interactions
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. After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally inhaled mometasone furoate increased. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the coadministration of ASMANEX HFA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) ] . Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.
Storage & Handling
16.2 Storage and Handling 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. Do not remove the canister from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Discard the inhaler when the labeled number of actuations has been used (the dose counter will read "0"). Store at controlled room temperature 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. After priming, store the inhaler with the mouthpiece down or in a horizontal position. For best results, keep the canister at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.
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