DULERA®

(mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol

Patient Education

Patient website for DULERA

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Counseling patients about DULERA

Discuss these questions and answers with patients taking DULERA.

What should I tell patients about the risk of asthma-related events—hospitalizations, intubations, and death?

See Patient Information.

Patients should be informed that use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART)]. 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 [see Serious Asthma-Related Events with ICS/LABA]. See Warnings and Precautions Section 5.1 of the Prescribing Information.

Can DULERA be used for acute asthma symptoms?

No. DULERA is not indicated to relieve acute asthma symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting, beta2-agonist (the health care provider should prescribe the patient with such medication and instruct the patient in how it should be used).

Patients should be instructed to seek medical attention immediately if they experience any of the following:

  • If their symptoms worsen
  • Significant decrease in lung function as outlined by the physician
  • If they need more inhalations of a short-acting beta2-agonist than usual

Patients should be advised not to increase the dose or frequency of DULERA. The daily dosage of DULERA should not exceed two inhalations twice daily. If they miss a dose, they should be instructed to take their next dose at the same time they normally do. DULERA provides bronchodilation for up to 12 hours.

Patients should not stop or reduce DULERA therapy without physician/provider guidance since symptoms may recur after discontinuation. See Warnings and Precautions Section 5.2 of the Prescribing Information.

Can additional LABAs be used with DULERA?

No. When patients are prescribed DULERA, other long-acting beta2-agonists should not be used. See Warnings and Precautions Section 5.3 of the Prescribing Information.

What are the risks of corticosteroid therapy?

Local effects: Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (ie, oral) antifungal therapy while still continuing with DULERA therapy, but at times therapy with DULERA may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised. See Warnings and Precautions Section 5.4 of the Prescribing Information.

Immunosuppression: Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. See Warnings and Precautions Section 5.5 of the Prescribing Information.

Hypercorticism and adrenal suppression: Patients should be advised that DULERA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to DULERA. See Warnings and Precautions Section 5.7 of the Prescribing Information.

Reduction in bone mineral density (BMD): Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk and should be monitored and, where appropriate, be treated for this condition. See Warnings and Precautions Section 5.12 of the Prescribing Information.

Reduced growth velocity: Patients should be informed that orally inhaled corticosteroids, a component of DULERA, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of pediatric patients taking corticosteroids by any route. See Warnings and Precautions Section 5.13 of the Prescribing Information.

Glaucoma and cataracts: Long-term use of inhaled corticosteroids may increase the risk of some eye problems (glaucoma or cataracts); consider referral to an ophthalmologist in patients who develop ocular symptoms or use DULERA long term. See Warnings and Precautions Section 5.14 of the Prescribing Information.

What are the risks of beta-agonist therapy?

Patients should be informed that treatment with beta2-agonists may lead to adverse events which include palpitations, chest pain, rapid heart rate, tremor or nervousness, and death. See Warnings and Precautions Section 5.11 of the Prescribing Information.

Indication

DULERA is indicated for the twice-daily treatment of asthma in patients 12 years of age and older.

DULERA is NOT indicated for the relief of acute bronchospasm.

Selected Safety Information

Serious Asthma-Related Events—Hospitalizations, Intubations, and Death

Use of long-acting beta2-adrenergic agonist (LABA) as monotherapy [without inhaled corticosteroids (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 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, tricyclic antidepressants, macrolides, or drugs known to prolong the QTc interval.

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.

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 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 accompanying Prescribing Information. The Patient Information also is available.

RESP-1087947-000806/18