The ELLIPTA inhaler portfolio of respiratory medicines from GSK

One inhaler. One inhalation. Once daily.

Indication for ANORO ANORO is for the once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ANORO is NOT for the relief of acute bronchospasm or for asthma.

Important Safety Information for ANORO (umeclidinium 62.5 mcg and vilanterol 25 mcg inhalation powder)
    WARNING: ASTHMA-RELATED DEATH
  • Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in ANORO, increase the risk of asthma-related death. cont'd below A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths. This finding with salmeterol is considered a class effect of all LABA.
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  • The safety and efficacy of ANORO in patients with asthma have not been established. ANORO is not indicated for the treatment of asthma.
  • CONTRAINDICATIONS
  • ANORO is contraindicated in patients with severe hypersensitivity to milk proteins or with hypersensitivity to umeclidinium, vilanterol, or any of the excipients.
  • WARNINGS AND PRECAUTIONS
  • ANORO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
  • ANORO is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • ANORO should not be used more often or at higher doses than recommended or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
  • Caution should be exercised when considering the coadministration of ANORO with long-term ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue ANORO and institute alternative therapy.
  • Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of ANORO. Discontinue ANORO if such reactions occur.
  • Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. If such effects occur, ANORO may need to be discontinued. ANORO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
  • Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
  • Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
  • Be alert to hypokalemia and hyperglycemia.
  • ADVERSE REACTIONS
  • The most common adverse reactions (≥1% and more common than placebo) reported in four 6-month clinical trials with ANORO (and placebo) were: pharyngitis, 2% (<1%); sinusitis, 1% (<1%); lower respiratory tract infection, 1% (<1%); constipation, 1% (<1%); diarrhea, 2% (1%); pain in extremity, 2% (1%); muscle spasms, 1% (<1%); neck pain, 1% (<1%); and chest pain, 1% (<1%).
  • In addition to the 6-month efficacy trials with ANORO, a 12-month trial evaluated the safety of umeclidinium/vilanterol 125 mcg/25 mcg in subjects with COPD. Adverse reactions (incidence ≥1% and more common than placebo) in subjects receiving umeclidinium/vilanterol 125 mcg/25 mcg were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus.
  • DRUG INTERACTIONS
  • Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors as increased systemic exposure to vilanterol and cardiovascular adverse effects may occur. See prior Warning and Precaution regarding CYP3A4 inhibitors.
  • ANORO should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
  • Use beta‐blockers with caution as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.
  • Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.
  • Avoid coadministration of ANORO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
  •  
  • Please see full Prescribing Information, including Boxed Warning and Medication Guide, for ANORO (umeclidinium 62.5 mcg and vilanterol 25 mcg inhalation powder).
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Indication for TRELEGY Once-daily TRELEGY is for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and for reducing exacerbations in patients with a history of exacerbations. TRELEGY is NOT indicated for relief of acute bronchospasm or asthma.

Important Safety Information for TRELEGY (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder)
  • CONTRAINDICATIONS
  • TRELEGY is contraindicated in patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, umeclidinium, vilanterol, or any of the excipients. cont'd below
  • WARNINGS AND PRECAUTIONS
  • TRELEGY is not for the treatment of asthma. LABA monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. 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 with ICS alone.
  • TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
  • TRELEGY is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
  • Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate. Advise patients to rinse their mouths with water without swallowing after inhalation.
  • Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported following use of inhaled corticosteroids, like fluticasone furoate.
  • Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
  • Particular care is needed for patients transferred from systemic corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY.
  • Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, appropriate therapy should be considered.
  • Caution should be exercised when considering the coadministration of TRELEGY with long‐term ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue TRELEGY and institute alternative therapy.
  • Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY if such reactions occur.
  • Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, TRELEGY may need to be discontinued. TRELEGY should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  • Decreases in bone mineral density have been observed with long‐term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating TRELEGY and periodically thereafter.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long‐term administration of inhaled corticosteroids or inhaled anticholinergics; therefore, monitoring is warranted.
  • Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
  • Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
  • Be alert to hypokalemia and hyperglycemia.
  • ADVERSE REACTIONS
  • The most common adverse reactions (≥1% and more common than placebo + FF/VI) reported in two 12-week clinical trials with umeclidinium + FF/VI, the components of TRELEGY, (and placebo + FF/VI) were: headache, 4% (3%); back pain, 4% (2%); dysgeusia, 2% (<1%); diarrhea, 2% (<1%); cough, 1% (<1%); oropharyngeal pain, 1% (0%); and gastroenteritis, 1% (0%).
  • Additional adverse reactions (≥1% incidence) reported in subjects taking TRELEGY in a 52-week trial included upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.
  • DRUG INTERACTIONS
  • TRELEGY should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
  • Use beta‐blockers with caution, as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.
  • Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.
  • Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects.
  • USE IN SPECIFIC POPULATIONS
  • Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.
  •  
  • Please see full Prescribing Information, including Patient Information, for TRELEGY (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder).
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Indications for BREO BREO ELLIPTA 100/25 is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BREO ELLIPTA 100/25 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA 100/25 is the only strength indicated for COPD.

BREO ELLIPTA is indicated for the once-daily treatment of asthma in patients aged 18 years and older. BREO ELLIPTA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).

BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.

Important Safety Information for BREO (fluticasone furoate 100, 200 mcg and vilanterol 25 mcg inhalation powder)
  • CONTRAINDICATIONS
  • The use of BREO is contraindicated in the following conditions:
  • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required. cont'd below
  • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients.
  • WARNINGS AND PRECAUTIONS
  • LABA monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. 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 with ICS alone.
  • BREO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.
  • BREO is not a rescue medication and should not be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • BREO should not be used more often or at higher doses than recommended or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
  • Oropharyngeal candidiasis has occurred in patients treated with BREO. Advise patients to rinse the mouth with water without swallowing after inhalation.
  • An increase in the incidence of pneumonia has been observed in subjects with COPD receiving BREO. There was also an increased incidence of pneumonias resulting in hospitalization. In some incidences these pneumonia events were fatal.
    • In replicate 12-month studies of subjects with moderate to severe COPD who had experienced a COPD exacerbation in the previous year, there was a higher incidence of pneumonia reported in subjects receiving BREO 100/25 (6% [51 of 806 subjects]) and BREO 200/25 (7% [55 of 811 subjects]) than in subjects receiving vilanterol 25 mcg (3% [27 of 818 subjects]). There was fatal pneumonia in 1 subject receiving BREO 100/25 and in 7 subjects receiving BREO 200/25 (<1% for each treatment group).
  • In a mortality trial in subjects with moderate COPD and cardiovascular disease, the annualized incidence rate of pneumonia was 3.4 per 100 patient-years for BREO 100/25 vs 3.2 for placebo.
  • Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as signs and symptoms of pneumonia and COPD exacerbations overlap.
  • Use caution in patients who use corticosteroids as they are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
  • Particular care is needed for patients transferred from systemic corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREO.
  • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, discontinue BREO slowly.
  • Caution should be exercised when considering the coadministration of BREO with long-term ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue BREO immediately and institute alternative therapy.
  • Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of BREO. Discontinue BREO if such reactions occur.
  • Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, BREO may need to be discontinued. BREO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  • In a mortality trial in subjects with moderate COPD and cardiovascular disease, the annualized incidence rate of cardiovascular adverse events was 2.5 per 100 patient-years for BREO 100/25 vs 2.7 for placebo.
  • Decreases in bone mineral density (BMD) have been observed with long‐term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care. Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating BREO and periodically thereafter.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with COPD or asthma following the long‐term administration of inhaled corticosteroids. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
  • Be alert to hypokalemia and hyperglycemia.
  • Orally inhaled corticosteroids may reduce growth velocity in children and adolescents.
  • ADVERSE REACTIONS: BREO 100/25 FOR COPD
  • In subjects with COPD, the most common adverse reactions (≥3% and more common than placebo) reported in two 6‐month clinical trials with BREO 100/25 (and placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%).
  • In addition to the events reported in the 6-month studies, adverse reactions occurring in ≥3% of the subjects treated with BREO 100/25 in two 1-year COPD studies included back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, influenza, pharyngitis, and pyrexia.
  • In addition to the events reported in the 6-month studies, in a mortality trial (median treatment duration of 1.5 years) in subjects with moderate COPD and cardiovascular disease, adverse reactions occurring in ≥3% of the subjects treated with BREO 100/25 and more common than placebo included pneumonia, back pain, hypertension, and influenza.
  • ADVERSE REACTIONS: BREO FOR ASTHMA
  • In a 12-week trial, adverse reactions (≥2% incidence and more common than placebo) reported in subjects taking BREO 100/25 (and placebo) were: nasopharyngitis, 10% (7%); headache, 5% (4%); oropharyngeal pain, 2% (1%); oral candidiasis, 2% (0%); and dysphonia, 2% (0%). In a separate 12-week trial, adverse reactions (≥2% incidence) reported in subjects taking BREO 200/25 (or BREO 100/25) were: headache, 8% (8%); nasopharyngitis, 7% (6%); influenza, 3% (3%); upper respiratory tract infection, 2% (2%); oropharyngeal pain, 2% (2%); sinusitis, 2% (1%); bronchitis, 2% (<1%); and cough, 1% (2%).
  • Additional adverse reactions (≥2% incidence) reported in subjects taking BREO 200/25 in a 24-week trial included viral respiratory tract infection, pharyngitis, pyrexia, and arthralgia, and with BREO 100/25 or 200/25 in a 12-month trial included pyrexia, back pain, extrasystoles, upper abdominal pain, respiratory tract infection, allergic rhinitis, pharyngitis, rhinitis, arthralgia, supraventricular extrasystoles, ventricular extrasystoles, acute sinusitis, and pneumonia.
  • In a 24- to 76-week trial of subjects with ≥1 asthma exacerbations in the past year, asthma-related hospitalizations occurred in 1% of subjects taking BREO 100/25. No asthma-related deaths or intubations were observed.
  • DRUG INTERACTIONS
  • Caution should be exercised when considering the coadministration of BREO with long‐term ketoconazole and other known strong CYP3A4 inhibitors. See prior Warning and Precaution regarding CYP3A4 inhibitors.
  • BREO should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
  • Use beta-blockers with caution as they not only block the pulmonary effect of beta-agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD or asthma.
  • Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.
  • USE IN SPECIFIC POPULATIONS
  • BREO is not indicated for children and adolescents. The safety and efficacy in patients aged ≤17 years have not been established.
  • Use BREO with caution in patients with moderate or severe hepatic impairment. Fluticasone furoate systemic exposure increased by up to 3-fold in subjects with hepatic impairment. Monitor for corticosteroid-related side effects.
  •  
  • Please see full Prescribing Information, including Patient Information, for BREO (fluticasone furoate 100, 200 mcg and vilanterol 25 mcg inhalation powder).
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Indication for INCRUSE INCRUSE is for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Safety Information for INCRUSE (umeclidinium 62.5 mcg inhalation powder)
  • CONTRAINDICATIONS
  • INCRUSE is contraindicated in patients with severe hypersensitivity to milk proteins or with hypersensitivity to umeclidinium or any of the excipients. cont'd below
  • WARNINGS AND PRECAUTIONS
  • INCRUSE should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
  • INCRUSE is not a rescue medication and does not replace fast-acting inhalers to treat acute symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • If paradoxical bronchospasm occurs, discontinue INCRUSE immediately and institute alternative therapy.
  • Hypersensitivity reactions such as anaphylaxis, angioedema, pruritus, rash, and urticaria may occur after administration of INCRUSE. Discontinue INCRUSE if such reactions occur.
  • Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
  • Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
  • ADVERSE REACTIONS
  • The most common adverse reactions ≥1% and more common than placebo with INCRUSE as monotherapy (and placebo) were: nasopharyngitis, 8% (7%); upper respiratory tract infection, 5% (4%); pharyngitis, 1% (<1%); viral upper respiratory tract infection, 1% (<1%); cough, 3% (2%); arthralgia, 2% (1%); myalgia, 1% (<1%); upper abdominal pain, 1% (<1%); toothache, 1% (<1%); contusion, 1% (<1%); tachycardia, 1% (<1%).
  • The adverse reactions in a long-term safety trial reported for umeclidinium 125 mcg as monotherapy with incidence ≥1% and exceeding that in placebo were: nasopharyngitis, upper respiratory tract infection, urinary tract infection, pharyngitis, pneumonia, lower respiratory tract infection, rhinitis, supraventricular tachycardia, supraventricular extrasystoles, sinus tachycardia, idioventricular rhythm, headache, dizziness, sinus headache, cough, back pain, arthralgia, pain in extremity, neck pain, myalgia, nausea, dyspepsia, diarrhea, rash, depression, and vertigo.
  • In addition to the adverse reactions reported in the umeclidinium monotherapy trials, adverse reactions reported in trials with INCRUSE in combination with an inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), at an incidence of ≥1% and exceeding ICS/LABA alone, were oropharyngeal pain and dysgeusia.
  • DRUG INTERACTIONS
  • Avoid coadministration of INCRUSE with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
  •  
  • Please see full Prescribing Information, including Patient Information, for INCRUSE (umeclidinium 62.5 mcg inhalation powder).
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Indication for ARNUITY ARNUITY is an inhaled corticosteroid indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. ARNUITY is NOT indicated for the relief of acute bronchospasm.

Important Safety Information for ARNUITY (fluticasone furoate inhalation powder) 50 mcg, 100 mcg, and 200 mcg
  • CONTRAINDICATIONS
  • ARNUITY is contraindicated for primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. cont'd below
  • ARNUITY is contraindicated in patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone furoate or any of the ingredients.
  • WARNINGS AND PRECAUTIONS
  • Oropharyngeal candidiasis has occurred in patients treated with ARNUITY. Advise patients to rinse the mouth with water without swallowing after inhalation.
  • ARNUITY is NOT a rescue medicine and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
  • Particular care is needed for patients transferred from systemic corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to ARNUITY.
  • Hypercorticism and adrenal suppression may occur with higher than the recommended dose or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, appropriate therapy should be considered.
  • Caution should be exercised when considering the coadministration of ARNUITY with long-term ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue ARNUITY and institute alternative therapy.
  • Hypersensitivity reactions such as urticaria, flushing, allergic dermatitis, and bronchospasm may occur after administration of ARNUITY. Discontinue ARNUITY if such reactions occur.
  • Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating ARNUITY and periodically thereafter.
  • Inhaled corticosteroids, as well as poorly controlled asthma, may cause a reduction in growth velocity, and the long-term effect on final adult height is unknown. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of children and adolescents.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long-term administration of inhaled corticosteroids; therefore, monitoring is warranted.
  • ADVERSE REACTIONS
  • Most common adverse reactions (≥5% of subjects ≥12 years of age) reported in a 24-week trial with ARNUITY 100 mcg (and placebo) were: nasopharyngitis 8% (5%), bronchitis 7% (6%), upper respiratory tract infection 6% (5%), headache 6% (4%).
  • Most common adverse reactions (≥5% of subjects ≥12 years of age) reported in a separate 24-week trial with ARNUITY 200 mcg (and 100 mcg) were: nasopharyngitis 13% (12%), headache 13% (10%), bronchitis 7% (12%), influenza 7% (4%), upper respiratory tract infection 6% (2%).
  • In a 12-week trial, adverse reactions (≥3% and greater than placebo) seen in subjects aged 5 to 11 years were similar to those reported in adult and adolescent subjects. Adverse reactions occurring in ≥3% of subjects treated with ARNUITY 50 mcg and greater than placebo were pharyngitis, bronchitis, and viral infection.
  • USE IN SPECIFIC POPULATIONS
  • Use ARNUITY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.
  •  
  • Please see full Prescribing Information, including Patient Information, for ARNUITY (fluticasone furoate inhalation powder) 50 mcg, 100 mcg, and 200 mcg.
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ANORO ELLIPTA, BREO ELLIPTA, and TRELEGY ELLIPTA were developed in collaboration with 

Trademarks are owned by or licensed to the GSK group of companies.

1005734R0 June 2018