ASMANEX

ASMANEX is an FDA-registered drug product whose active ingredient is MOMETASONE FUROATE. It is labelled by Organon LLC taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 78206-114, application NDA021067, label effective 20260707. It is one of 22 FDA drug label records sharing the active ingredient MOMETASONE FUROATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MOMETASONE FUROATE are most often described in connection with: asmanex twisthaler, years age, maintenance treatment, asthma prophylactic, older limitations, relief acute, children less, therapy adult. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE ASMANEX ® TWISTHALER ® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age. ASMANEX TWISTHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. ( 1 ) Limitations of Use: ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm ( 1 , 5.2 ) or in children less than 4 years of age ( 1 , 8.4 ).

2 DOSAGE AND ADMINISTRATION Administration Information Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. After administration, advise patients to rinse the mouth with water and spit out contents without swallowing. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients ≥12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established. For oral inhalation only. ( 2 ) Instruct patients to inhale rapidly and deeply and, after administration, rinse mouth with water and spit out contents without swallowing. ( 2 ) Recommended Dosages for ASMANEX TWISTHALER Treatment Previous Therapy Recommended Starting Dose Highest Recommended Daily Dose , , , Please refer to section 2.1 for full dosage recommendations and details. Patients ≥12 years who received bronchodilators alone 220 mcg once daily in the evening 440 mcg Patients ≥12 years who received inhaled corticosteroids 220 mcg once daily in the evening 440 mcg Patients ≥12 years who received oral corticosteroids 440 mcg twice daily 880 mcg Children 4-11 years of age 110 mcg once daily in the evening 110 mcg 2.1 Recommended Dosages in Adult and Pediatric Patients 4 Years of Age and Older The recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1 . Table 1: Recommended Dosages for ASMANEX TWISTHALER Treatment Previous Therapy Recommended Starting Dose Highest Recommended Daily Dose Patients ≥12 years who received bronchodilators alone 220 mcg once daily in the evening When administered once daily, ASMANEX TWISTHALER should be taken only in the evening. 440 mcg The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily. Patients ≥12 years who received inhaled corticosteroids 220 mcg once daily in the evening 440 mcg Patients ≥12 years who received oral corticosteroids For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.5) ] . 440 mcg twice daily 880 mcg Children 4-11 years of age Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy. 110 mcg once daily in the evening 110 mcg

4 CONTRAINDICATIONS ASMANEX TWISTHALER is contraindicated: Status Asthmaticus: in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity: in patients with known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER [see Warnings and Precautions (5.3) and Description (11) ]. Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Patients with a known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Oropharyngeal Candidiasis [see Warnings and Precautions (5.1) ] Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ] Growth Effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Glaucoma and Cataracts [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence ≥5%) are headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, and dyspepsia. ( 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 Studies Experience The safety data described below reflect exposure to ASMANEX TWISTHALER in 2380 patients with asthma exposed for 8 to 12 weeks and 627 patients with asthma exposed for 1 year in a total of 17 clinical trials. In adult and adolescent patients 12 years of age and older, ASMANEX TWISTHALER was studied in 10 placebo-controlled clinical trials of 8 to 12 weeks duration with a total of 1750 patients receiving ASMANEX TWISTHALER. There were also 3 trials with a total of 475 patients receiving ASMANEX TWISTHALER for 1 year. In the 8- to 12-week clinical trials, the population was 12 to 83 years of age; 38% males and 62% females; and 83% Caucasian, 8% black, 6% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg twice daily (n=133), 220 mcg once daily in the morning (n=209), 220 mcg once daily in the evening (n=232), 220 mcg twice daily (n=433), 440 mcg once daily in the morning (n=419), 440 mcg once daily in the evening (n=250), or 440 mcg twice daily (n=74). In 3 long-term safety trials (two 9-month extensions of efficacy trials and one 52-week active-controlled safety trial), 475 patients with asthma (12-83 years of age, 44% males, 56% females, 87% Caucasian, 8% black, 4% Hispanic, and 1% other race/ethnicity) received various doses of ASMANEX TWISTHALER for 1 year. In pediatric patients 4 to 11 years of age, ASMANEX TWISTHALER was studied in 3 placebo-controlled clinical trials of 12 weeks duration with a total of 630 patients receiving ASMANEX TWISTHALER and a 52-week, active-controlled safety trial with a total of 152 patients receiving ASMANEX TWISTHALER. In the 12-week clinical trials, the population was 4 to 11 years of age; 63% males and 37% females; and 67% Caucasian, 13% black, 17% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg once daily in the evening (n=98), 110 mcg once daily in the morning (n=181), 110 mcg twice daily (n=179), or 220 mcg once daily in the morning (n=172). In the long-term active-controlled safety trial (n=152), patients with asthma (4 to 11 years of age, 60% males and 40% females, 84% Caucasian, 11% Black, and 5% Hispanic) received ASMANEX TWISTHALER 110 mcg twice daily or 220 mcg once daily in the morning for 52 weeks. 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. Adults and Adolescents 12 Years of Age and Older: The safety results of the 10 trials that were 8 to 12 weeks in duration were pooled because patients with asthma in these studies were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results of the one 12-week clinical trial in patients with asthma previously treated with oral corticosteroids are presented separately. In the pooled 8- to 12-week clinical trials, adverse reactions were reported in 70% of patients treated with ASMANEX TWISTHALER (n=1750) compared to 65% of patients taking placebo (n=720). Table 2 displays the common adverse reactions (≥3% in any patient group receiving ASMANEX TWISTHALER) that occurred more frequently in patients treated with ASMANEX TWISTHALER compared to patients treated with placebo. Table 2: Adverse Reactions with ≥3% Incidence in 10 Controlled Clinical Trials with ASMANEX TWISTHALER in Patients 12 Years of Age and Older Previously on Bronchodilators and/or Inhaled Corticosteroids (%) of Patients ASMANEX TWISTHALER Adverse Reaction 220 mcg twice daily (n=433) 440 mcg once daily (n=497) 220 mcg once daily in the evening (n=232) Placebo (n=720) Headache 22 17 20 20 Allergic Rhinitis 15 11 14 13 Pharyngitis 11 8 13 7 Upper Respiratory Infection 10 8 15 7 Sinusitis 6 6 5 5 Candidiasis, oral 6 4 4 2 Dysmenorrhea Percentages are based on the number of female patients. 9 4 4 4 Musculoskeletal Pain 8 4 4 5 Back Pain 6 3 3 4 Dyspepsia 5 3 3 3 Myalgia 3 2 3 2 Abdominal Pain 3 2 3 2 Nausea 3 1 3 2 Average Duration of Exposure (Days) 81 70 80 62 The following other adverse reactions occurred in these clinical trials with an incidence of at least 1% but less than 3% and were more common on ASMANEX TWISTHALER therapy than on placebo: Body as a Whole: fatigue, flu-like symptoms, pain Gastrointestinal: gastroenteritis, vomiting, anorexia Hearing, Vestibular: earache Resistance Mechanism: infection Respiratory: dysphonia, epistaxis, nasal irritation, respiratory disorder, throat dry In the 12-week trial in adult asthmatics who previously required oral corticosteroids, the effects of ASMANEX TWISTHALER therapy administered as two 220-mcg inhalations twice daily (n=46) were compared with those of placebo (n=43). Adverse reactions, whether considered drug-related or not by the investigators, reported in more than 3 patients in the ASMANEX TWISTHALER treatment group, and which occurred more frequently than in placebo were (ASMANEX TWISTHALER % vs. placebo %): musculoskeletal pain (22% vs. 14%), oral candidiasis (22% vs. 9%), sinusitis (22% vs. 19%), allergic rhinitis (20% vs. 5%), upper respiratory infection (15% vs. 14%), arthralgia (13% vs. 7%), fatigue (13% vs. 2%), depression (11% vs. 0%), and sinus congestion (9% vs. 0%). In considering these data, an increased duration of exposure for patients on ASMANEX TWISTHALER treatment (77 days vs. 58 days on placebo) should be taken into account. Long-Term Clinical Trials Experience - 12 Years of Age and Older: In 3 long-term safety trials, 475 patients with asthma 12 years of age and older were treated with ASMANEX TWISTHALER 220 mcg twice daily (n=60), 220 mcg once daily in the morning (n=41), 220 mcg once daily in the evening (n=40), 440 mcg once daily in the morning (n=44), 440 mcg once daily in the evening (n=41), 440 mcg twice daily (n=62), 880 mcg once daily (n=59), or at variable doses (n=128) for 52 weeks. The safety profile of ASMANEX TWISTHALER in the 52-week trials was similar to the findings in the 8- to 12-week clinical trials. In patients previously on inhaled corticosteroids, cataracts were reported in 3 patients (0.9%) treated with ASMANEX TWISTHALER, compared to 1 patient (1.7%) treated with the active comparator medication. Increased ocular pressure at the end of the study was observed in 2 patients, both on ASMANEX TWISTHALER 880 mcg once daily in the morning. Oral candidiasis, dysphonia, and dysmenorrhea were seen at a higher frequency with long-term administration than in the 8- to 12-week trials. Pediatric Patients 4 to 11 Years of Age: In the three 12-week clinical trials in pediatric patients 4 to 11 years of age, patients with asthma were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results from 1 trial are described in Table 3 for ASMANEX TWISTHALER 110 mcg once daily in the evening. The safety results from the other 2 trials showed similar findings. Overall adverse reactions were reported with approximately the same frequency by patients treated with ASMANEX TWISTHALER and those receiving placebo. Table 3 displays the common adverse reactions (≥2% in any patient group receiving ASMANEX TWISTHALER) that occurred more frequently in patients 4 to 11 years of age treated with ASMANEX TWISTHALER compared with placebo-treated patients. Table 3: Adverse Reactions with ≥2% Incidence in a 12-Week Study with ASMANEX TWISTHALER in Patients 4 to 11 Years of Age Previously on Bronchodilators and/or Inhaled Corticosteroids (%) of Patients ASMANEX TWISTHALER Adverse Reaction 110 mcg once daily in the evening (n=98) Placebo (n=99) Fever 7 5 Allergic Rhinitis 4 3 Abdominal Pain 6 2 Vomiting 3 2 Urinary Tract Infection 2 1 Bruise 2 0 Average Duration of Exposure (Days) 72 68 Long-Term Clinical Trials Experience in Children 4 to 11 Years of Age: In a 52-week, active-controlled, long-term safety trial, 152 patients with asthma 4 to 11 years of age were treated with ASMANEX TWISTHALER 110 mcg twice daily (n=74) or 220 mcg once daily (n=78). The safety profile for ASMANEX TWISTHALER in the 52-week trial was similar to the findings in the 12-week clinical trials. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of ASMANEX TWISTHALER. Because they 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 (5.9) ] . Immune System Disorders: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction [see Warnings and Precautions (5.3) and Contraindications (4) ] . Respiratory, Thoracic and Mediastinal Disorders: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.

FDA lists 22 drug label records with MOMETASONE FUROATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is ASMANEX used for?
1 INDICATIONS AND USAGE ASMANEX ® TWISTHALER ® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age. ASMANEX TWISTHALER is a corticosteroid indicated …

Who makes ASMANEX?
Organon LLC is the labeler of record for ASMANEX. 22 FDA label records share the active ingredient MOMETASONE FUROATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does ASMANEX come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ASMANEX prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MOMETASONE FUROATE?
Yes. 22 FDA drug label records list MOMETASONE FUROATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has ASMANEX been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.