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DULERA is indicated for the treatment of asthma in patients 12 years of age and older.
DULERA is NOT indicated for the relief of acute bronchospasm.

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Review clinical data about DULERA from a 26-week study.

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Selected Important Safety Information about DULERA

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in DULERA, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

When treating patients with asthma, prescribe DULERA only for patients with asthma not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue DULERA) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use DULERA for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

  • DULERA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
    DULERA is contraindicated in patients with known hypersensitivity to any of the ingredients in DULERA.
  • DULERA is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms. Increasing use of inhaled, short-acting beta2-agonists is a marker for deteriorating asthma. In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen.
  • Patients using DULERA should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.
  • Oropharyngeal candidiasis may occur. If candidiasis develops, it should be treated with appropriate antifungal therapy, but at times therapy with DULERA may need to be interrupted. Advise patients to rinse the mouth after inhalation.
  • DULERA should be used with caution in patients with tuberculosis, fungal, bacterial, viral (including chickenpox or measles), or parasitic infections; or ocular herpes simplex infections because of the potential for worsening of these infections. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • Particular care is needed for patients who are transferred from systemically active corticosteroids to DULERA. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
  • Hypercorticism and adrenal suppression may occur with very high dosages of DULERA or at the regular dosage in susceptible individuals. Patients treated with DULERA should be observed carefully for any evidence of systemic corticosteroid effects. If such changes occur, discontinue DULERA slowly.
  • Caution should be exercised when considering the coadministration of DULERA with long-term ketoconazole and other known strong CYP3A4 inhibitors, or in patients being treated with MAO inhibitors or tricyclic antidepressants.
  • Discontinue DULERA and institute alternative therapy if paradoxical bronchospasm occurs.
  • Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. DULERA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  • Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate, a component of DULERA. Patients with major risk factors for decreased BMD should be monitored and treated with established standards of care.
  • Inhaled corticosteroids, including DULERA, may cause a reduction in growth velocity when administered in pediatric patients.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term inhaled corticosteroids, including mometasone furoate, a component of DULERA.
  • DULERA, like other medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
  • Be alert to hypokalemia and hyperglycemia as beta2-agonist medications such as DULERA have the potential to produce adverse cardiovascular effects.
  • The most common treatment-emergent adverse events reported in ≥3% of patients and more common than placebo included nasopharyngitis, sinusitis, and headache.
  • Dysphonia was reported in a longer-term treatment trial at an incidence of 5% in patients receiving DULERA 100 mcg/5 mcg and 3.8% in patients receiving DULERA 200 mcg/5 mcg.

Before prescribing DULERA, please read the Prescribing Information about DULERA, including the Boxed Warning about asthma-related death. The Medication Guide also is available.

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