DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older.
DULERA is NOT indicated for the relief of acute bronchospasm.
Selected Safety Information
- 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.
- Serious Asthma-Related Events — Hospitalizations, Intubations, and Death
Use of long-acting beta2-adrenergic agonist (LABA) as monotherapy [without inhaled corticosteroid (ICS)] for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART) in PI section 5.1]. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone.
- 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 more than 2 inhalations twice daily of the prescribed dosage strength of DULERA, additional formoterol, or other long-acting inhaled beta2-agonists for any reason as an overdose may result. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
- 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 their mouth with water and, without swallowing, spit out the contents after each dose (2 inhalations) to help reduce the risk.
- 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, tricyclic antidepressants, macrolides, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents.
- There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
- 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. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
- 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. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use DULERA long term.
- DULERA, like other medications containing sympathomimetic amines, should be used with caution in patients with aneurysm, pheochromocytoma, 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 aged 12 years and older and more common than placebo included nasopharyngitis, sinusitis, and headache. Common treatment-emergent adverse events that occurred in patients aged 5 to less than 12 years treated with DULERA with an incidence of ≥3% and more frequently than patients with mometasone furoate alone included influenza, upper respiratory tract infection, and headache. Overall, the safety profile for pediatric patients is similar to that observed in patients aged 12 years and older.
- Dysphonia was reported in a longer-term treatment trial at an incidence of 5% in patients aged 12 years and older receiving DULERA 100 mcg/5 mcg and 3.8% in patients receiving DULERA 200 mcg/5 mcg.
Before prescribing DULERA, please read the accompanying Prescribing Information. The Patient Information also is available.