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warnings and cautions
5 WARNINGS AND PRECAUTIONS BRONCHITOL can cause bronchospasm, which can be severe in susceptible patients. Because of the risk of bronchospasm, prior to prescribing BRONCHITOL, perform the BRONCHITOL tolerance test (BTT). The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm. Do not prescribe BRONCHITOL if the patient fails the BTT. Patients who pass the BTT may experience bronchospasm with maintenance use of BRONCHITOL. Advise patients to premedicate with an inhaled short-acting bronchodilator prior to each administration of BRONCHITOL. If bronchospasm occurs, immediately discontinue BRONCHITOL. Treat bronchospasm with an inhaled short-acting bronchodilator. ( 2.1 , 5.1 ) Hemoptysis can occur with BRONCHITOL use. Monitor patients with history of episodes of hemoptysis. If hemoptysis occurs, discontinue use of BRONCHITOL ( 5.2 ) 5.1 Bronchospasm BRONCHITOL Tolerance Test BRONCHITOL can cause bronchospasm, which can be severe in susceptible individuals. Because of the risk of bronchospasm, prior to prescribing BRONCHITOL, perform the BRONCHITOL Tolerance Test (BTT), to identify patients who are appropriate for maintenance treatment with BRONCHITOL. The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm. In clinical trials, 896 adult patients with cystic fibrosis underwent the BTT and 72 patients (8%) failed or did not complete the BTT. Do not prescribe BRONCHITOL if the patient fails the BTT. Maintenance Therapy Bronchospasm may occur during inhalation of BRONCHITOL, even in patients who have passed the BTT. An inhaled short-acting bronchodilator must be administered 5-15 minutes before administration of each dose during maintenance therapy. In clinical studies, bronchospasm or bronchial hyperreactivity was reported in 4 of 414 adult patients (1.0%) receiving BRONCHITOL as maintenance therapy and in 2 of 347 adult patients (0.6%) receiving control (50 mg inhaled mannitol), even though these patients had passed the BTT. If bronchospasm occurs following dosing of BRONCHITOL, it should immediately be discontinued and treated with an inhaled short-acting bronchodilator or as medically appropriate. 5.2 Hemoptysis Hemoptysis may occur with BRONCHITOL use. Hemoptysis was reported in 43 (10.4%) adult patients receiving BRONCHITOL and in 33 (9.5%) adult patients receiving control (50 mg inhaled mannitol) during clinical studies. In patients aged 6 years to 17 years, hemoptysis was reported in 12 of 154 (7.8%) patients who received BRONCHITOL and in 2 of 105 (1.9%) patients who received control. BRONCHITOL has not been studied in patients with a history of episodes of significant hemoptysis (volume greater than 60 mL) in the previous 3 months. BRONCHITOL should be discontinued in the event of hemoptysis. BRONCHITOL is not indicated for use in children and adolescents.
warnings and cautions
5.1 Bronchospasm BRONCHITOL Tolerance Test BRONCHITOL can cause bronchospasm, which can be severe in susceptible individuals. Because of the risk of bronchospasm, prior to prescribing BRONCHITOL, perform the BRONCHITOL Tolerance Test (BTT), to identify patients who are appropriate for maintenance treatment with BRONCHITOL. The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm. In clinical trials, 896 adult patients with cystic fibrosis underwent the BTT and 72 patients (8%) failed or did not complete the BTT. Do not prescribe BRONCHITOL if the patient fails the BTT. Maintenance Therapy Bronchospasm may occur during inhalation of BRONCHITOL, even in patients who have passed the BTT. An inhaled short-acting bronchodilator must be administered 5-15 minutes before administration of each dose during maintenance therapy. In clinical studies, bronchospasm or bronchial hyperreactivity was reported in 4 of 414 adult patients (1.0%) receiving BRONCHITOL as maintenance therapy and in 2 of 347 adult patients (0.6%) receiving control (50 mg inhaled mannitol), even though these patients had passed the BTT. If bronchospasm occurs following dosing of BRONCHITOL, it should immediately be discontinued and treated with an inhaled short-acting bronchodilator or as medically appropriate.
warnings and cautions
5.2 Hemoptysis Hemoptysis may occur with BRONCHITOL use. Hemoptysis was reported in 43 (10.4%) adult patients receiving BRONCHITOL and in 33 (9.5%) adult patients receiving control (50 mg inhaled mannitol) during clinical studies. In patients aged 6 years to 17 years, hemoptysis was reported in 12 of 154 (7.8%) patients who received BRONCHITOL and in 2 of 105 (1.9%) patients who received control. BRONCHITOL has not been studied in patients with a history of episodes of significant hemoptysis (volume greater than 60 mL) in the previous 3 months. BRONCHITOL should be discontinued in the event of hemoptysis. BRONCHITOL is not indicated for use in children and adolescents.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Bronchospasm [see Warnings and Precautions ( 5.1 )] Hemoptysis [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥3%) include cough, hemoptysis, oropharyngeal pain, vomiting, bacteria sputum identified, pyrexia, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The overall safety profile for BRONCHITOL is based on data from 1,020 CF patients from three 26-week, randomized, double-blind, controlled trials (Trials 1, 2, and 3). While CF patients aged 6 to 17 years were included in two of the three trials, BRONCHITOL is not indicated for use in this age group [ see Indications (1), Use in Specific Populations (8) ]. The safety data described below are based on 761 adult patients who received at least one dose of study drug in the three trials. Of the 761 adult patients, 45% of patients were female and 98% were Caucasian; 414 received BRONCHITOL and 347 received control (50 mg inhaled mannitol) for up to 26 weeks. Adult patients treated with BRONCHITOL were ages 18 to 59 years with a mean baseline FEV 1 of 62.0% of predicted. In these three trials, the proportion of adult patients who prematurely discontinued study drug due to adverse reactions was 12.3% for patients treated with BRONCHITOL and 8.6% for patients treated with control. Serious adverse reactions occurred in 18.8% of patients treated with BRONCHITOL and 18.4% of patients treated with control. Serious adverse reactions occurring with greater than 1% incidence and more frequently in BRONCHITOL-treated adult patients compared to control-treated patients were CF exacerbations (13.3% vs. 11.2%), hemoptysis (1.4% vs. 1.2%) and lower respiratory tract infection (1.2% vs 0.9%). The incidence of Adverse Reactions in adults during the 26 week treatment period with BRONCHITOL across the three trials is shown in Table 1. Table 1. Adverse Reactions Occurring With ≥3% Incidence and More Common Than Control in Adult CF Patients (Trials 1, 2, and 3) Primary System Organ Class Preferred Term BRONCHITOL N = 414 % CONTROL N = 347 % Respiratory, thoracic, and mediastinal disorders Cough 15.0 10.7 Hemoptysis 10.4 9.5 Oropharyngeal pain 7.0 4.3 Gastrointestinal disorders Vomiting 3.1 1.4 Investigations Bacteria sputum identified 6.8 4.6 General disorders and administrative site conditions Pyrexia 4.6 2.3 Musculoskeletal and connective tissue disorders Arthralgia 3.1 2.6 In Trials 1, 2, and 3, exacerbations of cystic fibrosis (reported as condition aggravated) occurred in 132 of 414 (32%) adult patients receiving BRONCHITOL and in 114 of 347 (33%) adult patients receiving control (50 mg inhaled mannitol). Exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 55 of 414 adult patients (13%) receiving BRONCHITOL and in 39 of 347 adult patients (11%) receiving control. Within the U.S. adult subgroup (comprising 27% of adults enrolled), exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 23 of 110 (21%) patients receiving BRONCHITOL and in 10 of 93 (11%) patients receiving control. Among the non-U.S. adult subgroup (comprising 73% of adults enrolled), exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 11% of patients in each treatment arm.
adverse reactions
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The overall safety profile for BRONCHITOL is based on data from 1,020 CF patients from three 26-week, randomized, double-blind, controlled trials (Trials 1, 2, and 3). While CF patients aged 6 to 17 years were included in two of the three trials, BRONCHITOL is not indicated for use in this age group [ see Indications (1), Use in Specific Populations (8) ]. The safety data described below are based on 761 adult patients who received at least one dose of study drug in the three trials. Of the 761 adult patients, 45% of patients were female and 98% were Caucasian; 414 received BRONCHITOL and 347 received control (50 mg inhaled mannitol) for up to 26 weeks. Adult patients treated with BRONCHITOL were ages 18 to 59 years with a mean baseline FEV 1 of 62.0% of predicted. In these three trials, the proportion of adult patients who prematurely discontinued study drug due to adverse reactions was 12.3% for patients treated with BRONCHITOL and 8.6% for patients treated with control. Serious adverse reactions occurred in 18.8% of patients treated with BRONCHITOL and 18.4% of patients treated with control. Serious adverse reactions occurring with greater than 1% incidence and more frequently in BRONCHITOL-treated adult patients compared to control-treated patients were CF exacerbations (13.3% vs. 11.2%), hemoptysis (1.4% vs. 1.2%) and lower respiratory tract infection (1.2% vs 0.9%). The incidence of Adverse Reactions in adults during the 26 week treatment period with BRONCHITOL across the three trials is shown in Table 1. Table 1. Adverse Reactions Occurring With ≥3% Incidence and More Common Than Control in Adult CF Patients (Trials 1, 2, and 3) Primary System Organ Class Preferred Term BRONCHITOL N = 414 % CONTROL N = 347 % Respiratory, thoracic, and mediastinal disorders Cough 15.0 10.7 Hemoptysis 10.4 9.5 Oropharyngeal pain 7.0 4.3 Gastrointestinal disorders Vomiting 3.1 1.4 Investigations Bacteria sputum identified 6.8 4.6 General disorders and administrative site conditions Pyrexia 4.6 2.3 Musculoskeletal and connective tissue disorders Arthralgia 3.1 2.6 In Trials 1, 2, and 3, exacerbations of cystic fibrosis (reported as condition aggravated) occurred in 132 of 414 (32%) adult patients receiving BRONCHITOL and in 114 of 347 (33%) adult patients receiving control (50 mg inhaled mannitol). Exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 55 of 414 adult patients (13%) receiving BRONCHITOL and in 39 of 347 adult patients (11%) receiving control. Within the U.S. adult subgroup (comprising 27% of adults enrolled), exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 23 of 110 (21%) patients receiving BRONCHITOL and in 10 of 93 (11%) patients receiving control. Among the non-U.S. adult subgroup (comprising 73% of adults enrolled), exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 11% of patients in each treatment arm.
adverse reactions table
<table width="100%"><caption>Table 1. Adverse Reactions Occurring With ≥3% Incidence and More Common Than Control in Adult CF Patients (Trials 1, 2, and 3) </caption><col width="159.6pt"/><col width="93.3pt"/><col width="1.25in"/><tbody><tr><td align="center"><paragraph><content styleCode="bold">Primary System Organ Class</content></paragraph><paragraph> Preferred Term</paragraph></td><td align="center" styleCode=" Lrule"><paragraph><content styleCode="bold">BRONCHITOL</content></paragraph><paragraph><content styleCode="bold">N = 414</content></paragraph><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode=" Lrule"><paragraph><content styleCode="bold">CONTROL</content></paragraph><paragraph><content styleCode="bold">N = 347</content></paragraph><paragraph><content styleCode="bold">%</content></paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">Respiratory, thoracic, and mediastinal disorders</content></paragraph></td></tr><tr><td styleCode=" Botrule Toprule"><paragraph>Cough</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>15.0</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>10.7</paragraph></td></tr><tr><td styleCode=" Botrule Toprule"><paragraph>Hemoptysis</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>10.4</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>9.5</paragraph></td></tr><tr><td styleCode=" Botrule Toprule"><paragraph>Oropharyngeal pain</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>7.0</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>4.3</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">Gastrointestinal disorders</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Vomiting</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>3.1</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>1.4</paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">Investigations</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Bacteria sputum identified</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>6.8</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>4.6</paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">General disorders and administrative site conditions</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Pyrexia</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>4.6</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>2.3</paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Arthralgia</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>3.1</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>2.6</paragraph></td></tr></tbody></table>
adverse reactions table
<table width="100%"><caption>Table 1. Adverse Reactions Occurring With ≥3% Incidence and More Common Than Control in Adult CF Patients (Trials 1, 2, and 3) </caption><col width="159.6pt"/><col width="93.3pt"/><col width="1.25in"/><tbody><tr><td align="center"><paragraph><content styleCode="bold">Primary System Organ Class</content></paragraph><paragraph> Preferred Term</paragraph></td><td align="center" styleCode=" Lrule"><paragraph><content styleCode="bold">BRONCHITOL</content></paragraph><paragraph><content styleCode="bold">N = 414</content></paragraph><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode=" Lrule"><paragraph><content styleCode="bold">CONTROL</content></paragraph><paragraph><content styleCode="bold">N = 347</content></paragraph><paragraph><content styleCode="bold">%</content></paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">Respiratory, thoracic, and mediastinal disorders</content></paragraph></td></tr><tr><td styleCode=" Botrule Toprule"><paragraph>Cough</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>15.0</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>10.7</paragraph></td></tr><tr><td styleCode=" Botrule Toprule"><paragraph>Hemoptysis</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>10.4</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>9.5</paragraph></td></tr><tr><td styleCode=" Botrule Toprule"><paragraph>Oropharyngeal pain</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>7.0</paragraph></td><td styleCode=" Botrule Toprule Lrule"><paragraph>4.3</paragraph></td></tr><tr><td colspan="3"><paragraph><content styleCode="bold">Gastrointestinal disorders</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Vomiting</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>3.1</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>1.4</paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">Investigations</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Bacteria sputum identified</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>6.8</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>4.6</paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">General disorders and administrative site conditions</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Pyrexia</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>4.6</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>2.3</paragraph></td></tr><tr><td colspan="3" styleCode=" Toprule"><paragraph><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></paragraph></td></tr><tr><td styleCode=" Toprule"><paragraph>Arthralgia</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>3.1</paragraph></td><td styleCode=" Toprule Lrule"><paragraph>2.6</paragraph></td></tr></tbody></table>