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warnings and cautions
5 WARNINGS AND PRECAUTIONS Do not initiate in acutely deteriorating COPD or to treat acute symptoms. ( 5.1 ) If paradoxical bronchospasm occurs, discontinue SEEBRI NEOHALER immediately and institute alternative therapy. ( 5.2 ) Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur. ( 5.4 ) Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder neck obstruction and instruct patients to consult a physician immediately if symptoms occur. ( 5.5 ) 5.1 Deterioration of Disease and Acute Episodes SEEBRI NEOHALER should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD. SEEBRI NEOHALER has not been studied in subjects with acutely deteriorating COPD. The initiation of SEEBRI NEOHALER in this setting is not appropriate. SEEBRI NEOHALER should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. SEEBRI NEOHALER has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta 2 -agonist. COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If SEEBRI NEOHALER no longer controls symptoms of bronchoconstriction; the patient’s inhaled, short-acting beta 2 -agonist becomes less effective; or the patient needs more inhalation of a short-acting beta 2 -agonist than usual, these may be markers of deterioration of disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dose of SEEBRI NEOHALER beyond the recommended dose is not appropriate in this situation. 5.2 Paradoxical Bronchospasm As with other inhaled medicines, SEEBRI NEOHALER can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with SEEBRI NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; SEEBRI NEOHALER should be discontinued immediately, and alternative therapy instituted. 5.3 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions have been reported after administration of SEEBRI NEOHALER. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria, or skin rash, SEEBRI NEOHALER should be discontinued immediately and alternative therapy instituted. SEEBRI NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins. 5.4 Worsening of Narrow-Angle Glaucoma SEEBRI NEOHALER should be used with caution in patients with narrow-angle glaucoma. 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). Instruct patients to consult a physician immediately should any of these signs or symptoms develop. 5.5 Worsening of Urinary Retention SEEBRI NEOHALER should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail, in other sections Paradoxical bronchospasm [see Warnings and Precautions (5.2)] . Immediate hypersensitivity reactions [see Warnings and Precautions (5.3)] . Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.4)] . Worsening of urinary retention [see Warnings and Precautions (5.5)] . Most common adverse reactions (incidence greater than or equal to 2% and higher than placebo) are upper respiratory tract infection and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. The SEEBRI NEOHALER safety database included 3415 subjects with COPD in four 12-week lung function trials and one 52-week long-term safety study. A total of 1202 subjects received treatment with SEEBRI NEOHALER 15.6 mcg twice-daily (BID). The safety data described below are based on the four 12-week trials and the one 52-week trial. 12-Week Trials The incidence of adverse reactions associated with SEEBRI NEOHALER in Table 1 is based on four 12-week, placebo-controlled trials in 2908 subjects with COPD. In the total population, 61.2% of patients had moderate COPD and 37.8% had severe COPD. In these trials, 951 subjects received SEEBRI NEOHALER 15.6 mcg BID, 511 subjects received indacaterol 27.5 mcg BID, 508 subjects received a fixed-dose combination of indacaterol/glycopyrrolate 27.5 mcg/15.6 mcg BID, and 938 subjects received placebo. Overall, 62% were males, 90% were Caucasian, and the mean age was 63 years (ranging from 41 to 89 years). In this population, 53% were identified as current smokers with an average smoking history of 48 pack-years. The most common adverse reactions (incidence greater than or equal to 2% and higher than placebo) were upper respiratory tract infection and nasopharyngitis. The proportion of subjects who discontinued treatment due to adverse reactions was 2.4% for the SEEBRI NEOHALER-treated patients and 3.8% for placebo-treated patients. Table 1. Adverse reactions with SEEBRI NEOHALER (greater than or equal to 1% incidence and higher than placebo) in COPD patients Adverse Reaction SEEBRI NEOHALER 15.6 mcg BID (N=951) n (%) Placebo (N=938) n (%) Upper respiratory tract infection 32 (3.4) 22 (2.3) Nasopharyngitis 20 (2.1) 18 (1.9) Urinary tract infection 13 (1.4) 12 (1.3) Sinusitis 13 (1.4) 7 (0.7) Oropharyngeal pain 17 (1.8) 11 (1.2) Other adverse reactions occurring more frequently with SEEBRI NEOHALER than with placebo, but with an incidence of less than 1% include rash, pruritus, gastroenteritis, hypersensitivity, atrial fibrillation, insomnia, pain in extremity, dysuria, vomiting, productive cough, and diabetes mellitus/hyperglycemia. 52-Week Trial In a long-term safety trial, 507 subjects were treated for up to 52 weeks with glycopyrrolate 15.6 mcg twice-daily or indacaterol 75 mcg once-daily. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy trials described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the placebo-controlled trials of 12 weeks. Additional adverse reactions that occurred with a frequency greater than or equal to 2% in the group receiving glycopyrrolate 15.6 mcg twice-daily that exceeded the frequency of indacaterol 75 mcg once-daily in this trial were: diarrhea, nausea, upper abdominal pain, fatigue, bronchitis, pneumonia, rhinitis, back pain, arthralgia, dyspnea, and wheezing. 6.2 Postmarketing Experience The following additional adverse reactions have been identified during worldwide post-approval use of glycopyrrolate, the active ingredient in SEEBRI NEOHALER, at higher than the recommended dose. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are: angioedema, paradoxical bronchospasm and dysphonia.