Indicated for maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm or in children less than 4 years of age. A short acting beta2-agonist, such as albuterol, should be available at all times to treat acute asthma symptoms.

Particular care is needed for patients who are transferred from systemically active corticosteroids to ASMANEX TWISTHALER 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.

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans occurred in patients treated with ASMANEX TWISTHALER. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX TWISTHALER therapy, but at times therapy with the ASMANEX TWISTHALER may need to be interrupted.

ASMANEX TWISTHALER is contraindicated in:

• Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required
• Patients with a known hypersensitivity to milk proteins

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate.

Orally inhaled corticosteroids, including ASMANEX TWISTHALER, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ASMANEX TWISTHALER routinely (e.g., via stadiometry).

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.

Hypersensitivity reactions including rash, pruritus, angioedema, and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER.

As with other inhaled asthma medications, bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with ASMANEX TWISTHALER, it should be treated immediately with a fast-acting inhaled bronchodilator.

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.

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.

Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Caution should be exercised when considering the co-administration of ASMANEX TWISTHALER with ketoconazole, and other known strong 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.

There are no adequate and well-controlled studies of ASMANEX TWISTHALER use in pregnant women. Animal studies: evidence of teratogenicity including increased fetal malformations and decreased fetal growth.

It is not known if mometasone furoate is excreted in human milk. Other inhaled corticosteroids, similar to
mometasone furoate, are present in human milk. 

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• Nasal polyps. GoToSource

• Perennial allergic rhinitis. GoToSource

• Eosinophilic esophagitis. GoToSource

• Use in patients under the age of 4. GoToSource

Adrenal suppression, (adrenal glands not producing adequate amounts of steroid hormones), cataracts, glaucoma, decreased bone mineral density, decreased growth velocity in children and oral candidiasis. GoToSource

Upper respiratory tract infection, rhinitis (inflammation of mucous membrane of the nose), pharyngitis (inflammation of pharynx) and sinusitis. GoToSource

Muscle cramps and muscle twisting. GoToSource

Thinning and bruising of the skin. GoToSource

Increased risk of mycobacterium especially in patients with chronic obstructive pulmonary disease or in patients with prior pulmonary tuberculosis. GoToSource

Herpes simplex keratitis (viral infection of the eye). GoToSource

No major injury lawsuits reported.