Clinical Information
Gen. Code and Des.
59328 mometasone furoate INHALATION AER POW BA 220MCG(60)
GCN and Des.
24929 mometasone furoate INHALATION AER POW BA 220MCG(60)
Strength
220MCG
Dose Form
AEROSOL POWDER, BREATH ACTIVATED (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
48100808 ORALLY INHALED PREPARATIONS (STEROIDS)
68040000 ADRENALS
Active Ingredients
2205 mometasone furoate 83919237
Inactive Ingredients
2432 lactose 64044515
These highlights do not include all the information needed to use ASMANEX TWISTHALER safely and effectively. See full prescribing information for ASMANEX TWISTHALER.
ASMANEX® TWISTHALER® (mometasone furoate inhalation powder), for oral inhalation use
Initial U.S. Approval: 1987
RECENT MAJOR CHANGES
Dosage and Administration (2) 02/2021
Warnings and Precautions (5.1, 5.2) 02/2021
INDICATIONS AND USAGE
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).
DOSAGE AND ADMINISTRATION
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*
DOSAGE FORMS AND STRENGTHS
Inhalation powder:
220 mcg TWISTHALER: delivers 200 mcg mometasone furoate per actuation. (3)
110 mcg TWISTHALER: delivers 100 mcg mometasone furoate per actuation. (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects in the mouth and pharynx. After administration, advise patients to rinse mouth with water and spit out contents without swallowing. (5.1)
Deterioration of asthma or acute episodes: ASMANEX TWISTHALER should not be used for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.2)
Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of ASMANEX TWISTHALER. Discontinue ASMANEX TWISTHALER if such reactions occur. (5.3)
Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. (5.4)
Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to ASMANEX TWISTHALER. (5.5)
Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function, with very high dosages or at the regular dosage in susceptible individuals. If such changes occur discontinue ASMANEX TWISTHALER slowly. (5.6)
Reduction in bone mineral density with long-term administration. Monitor patients with major risk factors for decreased bone mineral content. (5.7)
Suppression of growth in children. Monitor growth routinely in pediatric patients receiving ASMANEX TWISTHALER. (5.8)
Glaucoma and cataracts. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX TWISTHALER long term. (5.9)
Paradoxical bronchospasm may occur with ASMANEX TWISTHALER. Treat bronchospasm immediately with a fast-acting inhaled bronchodilator and discontinue use of ASMANEX TWISTHALER. (5.10)
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects. Exercise caution when used with ASMANEX TWISTHALER. (5.11)
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. (7.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2021
