ASMANEX® TWISTHALER®

(mometasone furoate inhalation powder)

Dosing

Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. Advise patients to rinse the mouth after inhalation. 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.

Recommended dosages in 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 below.

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*
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*

* When administered once daily, ASMANEX TWISTHALER should be taken only in the evening.

† The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily.

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)].

§ Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy.

Dosage forms and strengths

  • ASMANEX TWISTHALER is a dry powder for inhalation that is available in 2 strengths.
  • ASMANEX TWISTHALER 220 mcg delivers 200 mcg mometasone furoate per actuation from the mouthpiece.
  • ASMANEX TWISTHALER 110 mcg delivers 100 mcg mometasone furoate per actuation from the mouthpiece.

Indication

ASMANEX TWISTHALER is for the maintenance treatment of asthma as prophylactic therapy in patients 4 years and older.

ASMANEX TWISTHALER is NOT indicated for the relief of acute bronchospasm or in patients less than 4 years old.

ASMANEX TWISTHALER is available in 2 dose strengths, 110 mcg for patients 4 to 11 years old, and 220 mcg for patients 12 years and older.

Selected Safety Information

ASMANEX TWISTHALER is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

ASMANEX TWISTHALER is contraindicated in patients with known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER. Hypersensitivity reactions including rash, pruritus, angioedema, and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER. In postmarketing experience with ASMANEX TWISTHALER, anaphylactic reactions in patients with milk protein allergy have been reported.

Oropharyngeal candidiasis may occur. If candidiasis develops, it should be treated with appropriate antifungal therapy, but at times therapy with ASMANEX TWISTHALER may need to be interrupted. Advise patients to rinse the mouth after inhalation.

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 TWISTHALER, 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 (4 years and older) receiving orally inhaled corticosteroids, including ASMANEX TWISTHALER, should be monitored routinely.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of ASMANEX TWISTHALER. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX TWISTHALER long term.

The most common adverse events with ASMANEX TWISTHALER (vs placebo) reported with ≥2% incidence in a clinical trial involving patients 4 to 11 years previously on bronchodilators and/or inhaled corticosteroids were: fever 7% (vs 5%), allergic rhinitis 4% (vs 3%), abdominal pain 6% (vs 2%), vomiting 3% (vs 2%), urinary tract infection 2% (vs 1%), and bruise 2% (vs 0%).

The most common adverse events with ASMANEX TWISTHALER (vs placebo) reported in clinical trials involving patients 12 years and older previously maintained on inhaled corticosteroids and/or bronchodilators were: headache, 17% to 22% (vs 20%); allergic rhinitis, 11% to 15% (vs 13%); pharyngitis, 8% to 13% (vs 7%); and upper respiratory infection, 8% to 15% (vs 7%).

The most common adverse events versus placebo for patients 12 years and older previously maintained on oral corticosteroids were ASMANEX TWISTHALER (vs placebo): musculoskeletal pain (22% vs 14%), oral candidiasis (22% vs 9%), allergic rhinitis (20% vs 5%), arthralgia (13% vs 7%), fatigue (13% vs 2%), depression (11% vs 0%), and sinus congestion (9% vs 0%).

Before prescribing ASMANEX® TWISTHALER® (mometasone furoate inhalation powder), please read the accompanying Prescribing Information. The Patient Information also is available.

RESP-1076949-002306/18