ASMANEX® TWISTHALER®

(mometasone furoate inhalation powder)

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