Important Safety Information & Indications for ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER
Important Safety Information
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US 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 all LABAs, including indacaterol, the active ingredient in ARCAPTA NEOHALER, and one of the active ingredients in UTIBRON NEOHALER.
The safety and efficacy of ARCAPTA NEOHALER or of UTIBRON NEOHALER in patients with asthma have not been established. ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated for the treatment of asthma.
All LABAs, including indacaterol, are contraindicated in patients with asthma without the use of a long-term asthma-control medication; ARCAPTA NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients, and UTIBRON NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients. SEEBRI NEOHALER is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.
ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
ARCAPTA NEOHALER or UTIBRON NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medicines containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using ARCAPTA NEOHALER or UTIBRON NEOHALER should not use another medicine containing a LABA for any reason.
Immediate hypersensitivity reactions have been reported with ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.
As with other inhaled medicines, ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER should be discontinued immediately and alternative therapy instituted.
Indacaterol, like other beta2-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. ARCAPTA NEOHALER and UTIBRON NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. beta2-adrenergic agonists may produce significant hypokalemia in some patients.
As with other beta2-adrenergic agonists, indacaterol should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.
As with other beta2-adrenergic agonists, ARCAPTA NEOHALER and UTIBRON NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.
ARCAPTA NEOHALER and UTIBRON NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. SEEBRI NEOHALER and UTIBRON NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any signs or symptoms develop.
In 6 clinical trials, 48% of ARCAPTA NEOHALER patients reported adverse reactions compared with 43% of placebo patients. The most common adverse events reported in ≥2% of patients taking ARCAPTA NEOHALER, and occurring more frequently than in patients taking placebo, were cough (6.5% vs 4.5%), nasopharyngitis (5.3% vs 2.7%), headache (5.1% vs 2.5%), nausea (2.4% vs 0.9%), and oropharyngeal pain (2.2% vs 0.7%). The most common serious adverse reactions of ARCAPTA NEOHALER patients were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation, which occurred at similar rates across treatment groups.
The most common adverse events reported in ≥1% of patients taking SEEBRI NEOHALER, and occurring more frequently than in patients taking placebo, were upper respiratory tract infection (3.4% vs 2.3%), nasopharyngitis (2.1% vs 1.9%), oropharyngeal pain (1.8% vs 1.2%), urinary tract infection (1.4% vs 1.3%), and sinusitis (1.4% vs 0.7%).
The most common adverse events reported in ≥1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis (4.1% vs 1.8%), hypertension (2.0% vs 1.4%), back pain (1.8% vs 0.6%), and oropharyngeal pain (1.6% vs 1.2%).
ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information, please see full Prescribing Information, including BOXED WARNINGS and Medication Guides, for ARCAPTA NEOHALER and UTIBRON NEOHALER, and Patient Information for SEEBRI NEOHALER at www.SunovionProFile.com/ARCAPTA, www.SunovionProFile.com/UTIBRON, and www.SunovionProFile.com/SEEBRI.
ARCAPTA® NEOHALER® (indacaterol) is a long-acting beta2-adrenergic agonist (LABA), SEEBRI® NEOHALER® (glycopyrrolate) is an anticholinergic, and UTIBRON® NEOHALER® (indacaterol and glycopyrrolate) is a combination of indacaterol and glycopyrrolate; all are indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important limitations: ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated to treat acute deteriorations of COPD and are not indicated to treat asthma.