Generic Name
Vilanterol
Brand Names
Anoro Ellipta, Breo Ellipta, Trelegy Ellipta, Umeclidinium
FDA approval date: August 26, 2013
Classification: Corticosteroid
Form: Powder
What is Anoro Ellipta (Vilanterol)?
ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease . Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of ANORO ELLIPTA in asthma have not been established. ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta 2 -adrenergic agonist , indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease . Limitations of Use: Not indicated for relief of acute bronchospasm or for the treatment of asthma. ( 1.
Approved To Treat
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Brand Information
Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate)
1INDICATIONS AND USAGE
ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Limitations of Use
ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of ANORO ELLIPTA in asthma have not been established.
2DOSAGE AND ADMINISTRATION
The recommended dosage of ANORO ELLIPTA for maintenance treatment of COPD is 62.5 mcg umeclidinium and 25 mcg vilanterol (1 actuation of ANORO ELLIPTA 62.5/25 mcg) once daily by oral inhalation.
- ANORO ELLIPTA should be used 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
3DOSAGE FORMS AND STRENGTHS
Inhalation powder: 62.5 mcg umeclidinium and 25 mcg vilanterol (62.5/25 mcg) per actuation.
4CONTRAINDICATIONS
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
- use of a long-acting beta
5ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Serious asthma-related events–hospitalizations, intubations, death
- Paradoxical bronchospasm
- Cardiovascular effects
- Worsening of narrow-angle glaucoma
- Worsening of urinary retention
5.1Clinical 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for ANORO ELLIPTA included 8,138 subjects with COPD in four 6‑month lung function trials, one 12-month long-term safety study, and 9 other trials of shorter duration. A total of 1,124 subjects have received at least 1 dose of ANORO ELLIPTA (umeclidinium/vilanterol 62.5/25 mcg), and 1,330 subjects have received a higher dose of umeclidinium/vilanterol (125/25 mcg). The safety data described below are based on the four 6-month and one 12-month trials. Adverse reactions observed in the other trials were similar to those observed in the confirmatory trials.
6-Month Trials
The incidence of adverse reactions associated with ANORO ELLIPTA in Table 1 is based on four 6-month trials: 2 placebo-controlled trials (Trial 1 and Trial 2); N = 1,532 and N = 1,489, respectively) and 2 active-controlled trials (Trial 3 and Trial 4); N = 843 and N = 869, respectively). Of the 4,733 subjects, 68% were male and 84% were white. They had a mean age of 63 years and an average smoking history of 45 pack-years, with 50% identified as current smokers. At screening, the mean postbronchodilator percent predicted forced expiratory volume in 1 second (FEV
Subjects received 1 dose once daily of the following: ANORO ELLIPTA, umeclidinium/vilanterol 125/25 mcg, umeclidinium 62.5 mcg, umeclidinium 125 mcg, vilanterol 25 mcg, active control, or placebo.
Other adverse reactions with ANORO ELLIPTA observed with an incidence <1% but more common than 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 (Trial 5), 335 subjects were treated for up to 12 months with umeclidinium/vilanterol 125/25 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 observed with a frequency of ≥1% in the group receiving umeclidinium/vilanterol 125/25 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.
5.2Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of ANORO ELLIPTA. 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 events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to ANORO ELLIPTA or a combination of these factors.
Cardiac Disorders
Palpitations.
Eye Disorders
Blurred vision, eye pain, glaucoma, increased intraocular pressure.
Immune System Disorders
Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria.
Nervous System Disorders
Dysgeusia, tremor.
Psychiatric Disorders
Anxiety.
Renal and Urinary Disorders
Dysuria, urinary retention.
Respiratory, Thoracic, and Mediastinal Disorders
Dysphonia, paradoxical bronchospasm.
6OVERDOSAGE
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.
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., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, 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.
7DESCRIPTION
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 C
Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1
Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C
ANORO ELLIPTA is a light grey and red plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder blend 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 blend 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 FEV
The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
8CLINICAL STUDIES
The safety and effectiveness of ANORO ELLIPTA were evaluated in a clinical development program that included 6 dose-ranging trials, 4 lung function trials of 6 months’ duration (2 placebo controlled and 2 active controlled), two 12-week crossover trials, and a 12-month long‑term safety trial. The efficacy of ANORO ELLIPTA is based primarily on the dose-ranging trials in 1,908 subjects with COPD or asthma
8.1Dose-Ranging Trials
Dose selection for ANORO ELLIPTA in COPD was based on dose-ranging trials for the individual components, vilanterol and umeclidinium. Based on the findings from these studies, once-daily doses of umeclidinium/vilanterol 62.5/25 mcg and umeclidinium/vilanterol 125/25 mcg were evaluated in the confirmatory COPD trials.
Umeclidinium
Dose selection for umeclidinium in COPD was supported by a 7-day, randomized, double-blind, placebo-controlled, crossover trial evaluating 4 doses of umeclidinium (15.6 to 125 mcg) or placebo dosed once daily in the morning in 163 subjects with COPD. A dose ordering was observed, with the 62.5- and 125-mcg doses demonstrating larger improvements in FEV
The differences in trough FEV
Evaluations of dosing interval by comparing once- and twice-daily dosing supported selection of a once-daily dosing interval for further evaluation in the confirmatory COPD trials.
Figure 3. Least Squares (LS) Mean Change from Baseline in Postdose Serial FEV
Day 1
Day 7
Vilanterol
Dose selection for vilanterol in COPD was supported by a 28-day, randomized, double-blind, placebo-controlled, parallel-group trial evaluating 5 doses of vilanterol (3 to 50 mcg) or placebo dosed in the morning in 602 subjects with COPD. Results demonstrated dose-related increases from baseline in FEV
Figure 4. Least Squares (LS) Mean Change from Baseline in Postdose Serial FEV
Day 1
Day 28
The differences in trough FEV
Dose-ranging trials in subjects with asthma evaluated doses from 3 to 50 mcg and 12.5 mcg once-daily versus 6.25 mcg twice-daily dosing frequency. The results supported the selection of the vilanterol 25 mcg once-daily dose for further evaluation in the confirmatory trials for COPD.
8.2Confirmatory Trials
Lung Function
The clinical development program for ANORO ELLIPTA included two 6-month, randomized, double-blind, placebo-controlled, parallel-group trials; two 6-month active-controlled trials; and two 12-week crossover trials in subjects with COPD designed to evaluate the efficacy of ANORO ELLIPTA on lung function. The 6-month trials treated 4,733 subjects that had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking ≥10 pack-years, had a post-albuterol FEV
Trial 1 (NCT01313650) evaluated ANORO ELLIPTA (umeclidinium/vilanterol 62.5/25 mcg), umeclidinium 62.5 mcg, vilanterol 25 mcg, and placebo. The primary endpoint was change from baseline in trough (predose) FEV
Trial 2 (NCT01313637) had a similar study design as Trial 1 but evaluated umeclidinium/vilanterol 125/25 mcg, umeclidinium 125 mcg, vilanterol 25 mcg, and placebo. Results for umeclidinium/vilanterol 125/25 mcg in Trial 2 were similar to those observed for ANORO ELLIPTA in Trial 1.
Results from the 2 active-controlled trials and the two 12-week trials provided additional support for the efficacy of ANORO ELLIPTA in terms of change from baseline in trough FEV
Serial spirometric evaluations throughout the 24-hour dosing interval were performed in a subset of subjects (n = 197) at Days 1, 84, and 168 in Trial 1. Results from Trial 1 at Day 1 and Day 168 are shown in Figure 5.
Figure 5. Least Squares (LS) Mean Change from Baseline in FEV
Day 1
Day 168
The peak FEV
Exacerbations
In Trial 6 (NCT02164513), a total of 10,355 subjects with COPD with a history of 1 or more moderate or severe exacerbations in the prior 12 months were randomized (1:2:2) to receive ANORO ELLIPTA (n = 2,070), fluticasone furoate/umeclidinium/vilanterol 100/62.5/25 mcg (n = 4,151), or fluticasone furoate/vilanterol 100/25 mcg (n = 4,134) administered once daily in a 12-month trial. The population demographics across all treatments were: mean age of 65 years, 77% white, 66% male, and an average smoking history of 46.6 pack-years, with 35% identified as current smokers. At trial entry, the most common COPD medications were ICS + anticholinergic + LABA (34%), ICS + LABA (26%), anticholinergic + LABA (8%), and anticholinergic (7%). The mean postbronchodilator percent predicted FEV
The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with fluticasone furoate/umeclidinium/vilanterol compared with the fixed-dose combinations of fluticasone furoate/vilanterol and ANORO ELLIPTA. Exacerbations were defined as worsening of 2 or more major symptoms (dyspnea, sputum volume, and sputum purulence) or worsening of any 1 major symptom together with any 1 of the following minor symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, and increased cough or wheeze for at least 2 consecutive days. Exacerbations were considered to be of moderate severity if treatment with systemic corticosteroids and/or antibiotics was required and were considered to be severe if resulted in hospitalization or death.
Contribution of Umeclidinium on COPD Exacerbations: Evidence of efficacy for ANORO ELLIPTA on COPD exacerbations was established by the efficacy of the umeclidinium component of fluticasone furoate/umeclidinium/vilanterol in Trial 6. Treatment with fluticasone furoate/umeclidinium/vilanterol statistically significantly reduced the on-treatment annual rate of moderate/severe exacerbations by 15% compared with fluticasone furoate/vilanterol (Table 3). A reduction in risk of on-treatment moderate/severe exacerbation (as measured by time to first) was also observed for the same comparison. The benefit of umeclidinium on exacerbations is not expected to diminish when combined with vilanterol in ANORO ELLIPTA.
ANORO ELLIPTA and COPD Exacerbations: In Trial 6, the primary efficacy analysis of the rate of moderate/severe exacerbations, treatment with fluticasone furoate/umeclidinium/vilanterol statistically significantly reduced the on-treatment annual rate of moderate/severe exacerbations by 25% compared with ANORO ELLIPTA (Table 3).
9HOW SUPPLIED/STORAGE AND HANDLING
ANORO ELLIPTA is supplied as a disposable light grey and red plastic inhaler containing 2 foil strips, each with 30 blisters (or 7 blisters for the institutional pack). One strip contains umeclidinium (62.5 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:
NDC 0173-0869-10 30 inhalations (60 blisters)
NDC 0173-0869-06 7 inhalations (14 blisters), institutional pack
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.
10PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Serious Asthma-Related Events
ANORO ELLIPTA is not indicated for the treatment of asthma. Inform patients that LABAs, such as vilanterol (one of the active ingredients in ANORO ELLIPTA), when used alone (without ICS) for asthma increase the risk of asthma-related hospitalization or asthma-related death.
Not for Acute Symptoms
Inform patients that ANORO ELLIPTA is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta
Instruct patients to seek medical attention immediately if they experience any of the following:
- Decreasing effectiveness of inhaled, short-acting beta
- Need for more inhalations than usual of inhaled, short-acting beta
- Significant decrease in lung function as outlined by the physician
Tell patients they should not stop therapy with ANORO ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation.
Do Not Use Additional Long-acting Beta
Instruct patients not to use other LABAs for COPD.
Paradoxical Bronchospasm
As with other inhaled medicines, ANORO ELLIPTA can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue ANORO ELLIPTA and contact their healthcare provider right away.
Risks Associated with Beta-agonist Therapy
Inform patients of adverse effects associated with beta
Worsening of Narrow-Angle Glaucoma
Instruct patients to 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 if any of these signs or symptoms develop.
Worsening of Urinary Retention
Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately if any of these signs or symptoms develop.
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