Drug: Anoro Ellipta
ANORO ELLIPTA is an inhalation powder drug product for delivery of a combination of umeclidinium (an anticholinergic) and vilanterol (a LABA) to patients by oral inhalation. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure: Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C29H34NO2•Br (as a quaternary ammonium bromide compound). It is slightly soluble in water. Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[(2,6dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol (1:1) and the following chemical structure: Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5•C20H16O2. It is practically insoluble in water. ANORO ELLIPTA is a light grey and red plastic inhaler containing 2 double-foil blister strips. Each blister on one strip contains a white powder mix of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), magnesium stearate (75 mcg), and lactose monohydrate (to 12.5 mg), and each blister on the other strip contains a white powder mix of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (to 12.5 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ANORO ELLIPTA delivers 55 mcg of umeclidinium and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC less than 70% and FEV1 less than 30% predicted or FEV1 less than 50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
LABA, such as vilanterol, one of the active ingredients in ANORO ELLIPTA, increase the risk of asthma-related death. ANORO ELLIPTA is not indicated for the treatment of asthma. [See BOXED WARNING and WARNINGS AND PRECAUTIONS] The following adverse reactions are described in greater detail in other sections:
Adverse Reaction Placebo
(n = 555)
% ANORO ELLIPTA
(n = 842)
% Umeclidinium 62.5 mcg
(n = 418)
% Vilanterol 25 mcg
(n = 1,034)
% Infections and infestations Pharyngitis < 1 2 1 2 Sinusitis < 1 1 < 1 1 Lower respiratory tract infection < 1 1 < 1 < 1 Gastrointestinal disorders Constipation < 1 1 < 1 < 1 Diarrhea 1 2 < 1 2 Musculoskeletal and connective tissue disorders Pain in extremity 1 2 < 1 2 Muscle spasms < 1 1 < 1 < 1 Neck pain < 1 1 < 1 < 1 General disorders and administration site conditions Chest pain < 1 1 < 1 < 1 Other adverse reactions with ANORO ELLIPTA observed with an incidence less than 1% but more common than with placebo included the following: productive cough, dry mouth, dyspepsia, abdominal pain, gastroesophageal reflux disease, vomiting, musculoskeletal chest pain, chest discomfort, asthenia, atrial fibrillation, ventricular extrasystoles, supraventricular extrasystoles, myocardial infarction, pruritus, rash, and conjunctivitis. 12-Month Trial In a long-term safety trial, 335 subjects were treated for up to 12 months with umeclidinium/vilanterol 125 mcg/25 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy trials described above. Adverse reactions that occurred with a frequency of greater than or equal to 1% in the group receiving umeclidinium/vilanterol 125 mcg/25 mcg that exceeded that in placebo in this trial were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus. Read the Anoro Ellipta (umeclidinium and vilanterol inhalation powder) Side Effects Center for a complete guide to possible side effectsLearn More »
- Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
- Cardiovascular effects [see WARNINGS AND PRECAUTIONS]
- Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
- Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
Adverse Reaction Placebo
(n = 555)
% ANORO ELLIPTA
(n = 842)
% Umeclidinium 62.5 mcg
(n = 418)
% Vilanterol 25 mcg
(n = 1,034)
% Infections and infestations Pharyngitis < 1 2 1 2 Sinusitis < 1 1 < 1 1 Lower respiratory tract infection < 1 1 < 1 < 1 Gastrointestinal disorders Constipation < 1 1 < 1 < 1 Diarrhea 1 2 < 1 2 Musculoskeletal and connective tissue disorders Pain in extremity 1 2 < 1 2 Muscle spasms < 1 1 < 1 < 1 Neck pain < 1 1 < 1 < 1 General disorders and administration site conditions Chest pain < 1 1 < 1 < 1 Other adverse reactions with ANORO ELLIPTA observed with an incidence less than 1% but more common than with placebo included the following: productive cough, dry mouth, dyspepsia, abdominal pain, gastroesophageal reflux disease, vomiting, musculoskeletal chest pain, chest discomfort, asthenia, atrial fibrillation, ventricular extrasystoles, supraventricular extrasystoles, myocardial infarction, pruritus, rash, and conjunctivitis. 12-Month Trial In a long-term safety trial, 335 subjects were treated for up to 12 months with umeclidinium/vilanterol 125 mcg/25 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy trials described above. Adverse reactions that occurred with a frequency of greater than or equal to 1% in the group receiving umeclidinium/vilanterol 125 mcg/25 mcg that exceeded that in placebo in this trial were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus. Read the Anoro Ellipta (umeclidinium and vilanterol inhalation powder) Side Effects Center for a complete guide to possible side effectsLearn More »
Source: http://www.rxlist.com
ANORO ELLIPTA (umeclidinium/vilanterol 62.5 mcg/25 mcg) should be administered as 1 inhalation once daily by the orally inhaled route only. ANORO ELLIPTA should be taken at the same time every day. Do not use ANORO ELLIPTA more than 1 time every 24 hours. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see CLINICAL PHARMACOLOGY].
Source: http://www.rxlist.com
Inhibitors Of Cytochrome P450 3A4 Vilanterol, a component of ANORO ELLIPTA, is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to vilanterol. Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. Monoamine Oxidase Inhibitors And Tricyclic Antidepressants Vilanterol, like other beta2-agonists, 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 the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias. Beta-Adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, a component of ANORO ELLIPTA, but may produce severe bronchospasm in patients with COPD. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of betaadrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution. Non–Potassium-Sparing Diuretics The electrocardiographic changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as vilanterol, a component of ANORO ELLIPTA, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of ANORO ELLIPTA with non–potassium-sparing diuretics. Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of ANORO ELLIPTA with other anticholinergiccontaining drugs as this may lead to an increase in anticholinergic adverse effects [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]. Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
ANORO ELLIPTA is a combination anticholinergic/long-acting beta2-adrenergic agonist (anticholinergic/LABA) 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. Important Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
Source: http://www.rxlist.com
The use of ANORO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients [see WARNINGS AND PRECAUTIONS, DESCRIPTION]. Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
No case of overdose has been reported with ANORO ELLIPTA. ANORO ELLIPTA contains both umeclidinium and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to ANORO ELLIPTA. Treatment of overdosage consists of discontinuation of ANORO ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage. Umeclidinium High doses of umeclidinium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a once-daily inhaled dose of up to 1,000 mcg umeclidinium (16 times the maximum recommended daily dose) for 14 days in subjects with COPD. Vilanterol The expected signs and symptoms with overdosage of vilanterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of vilanterol.
Source: http://www.rxlist.com
Dosage Forms And Strengths Inhalation Powder. Disposable light grey and red plastic inhaler containing 2 double-foil blister strips, each with 30 blisters containing powder intended for oral inhalation only. One strip contains umeclidinium (62.5 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). An institutional pack containing 7 blisters per strip is also available. Storage And Handling ANORO ELLIPTA is supplied as a disposable light grey and red plastic inhaler containing 2 double-foil blister strips with 30 blisters each. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0869-10). ANORO ELLIPTA is also supplied in an institutional pack of a disposable light grey and red plastic inhaler containing 2 double-foil blister strips with 7 blisters each. The inhaler is packaged in a moisture protective foil tray with a desiccant and a peelable lid (NDC 0173-086906). Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. ANORO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard ANORO ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart. GlaxoSmithKline, Research Triangle Park, NC 27709. December 2013 Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Asthma-Related Death
This monograph has been modified to include the generic and brand name in many instances.
- Data from a large placebo-controlled trial in subjects with asthma showed that LABA may increase the risk of asthma-related death. Data are not available to determine whether the rate of death in patients with COPD is increased by LABA.
- A 28-week, placebo-controlled, US trial comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in subjects receiving salmeterol (13/13,176 in subjects treated with salmeterol vs. 3/13,179 in subjects treated with placebo; relative risk: 4.37 [95% CI: 1.25, 15.34]). The increased risk of asthma-related death is considered a class effect of LABA, including vilanterol, one of the active ingredients in ANORO ELLIPTA.
- No trial adequate to determine whether the rate of asthma-related death is increased in subjects treated with ANORO ELLIPTA has been conducted. The safety and efficacy of ANORO ELLIPTA in patients with asthma have not been established. ANORO ELLIPTA is not indicated for the treatment of asthma.
- Symptoms get worse
- Need for more inhalations than usual of their rescue inhaler
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
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