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ANORO ELLIPTA is a brand name for Umeclidinium, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ANORO ELLIPTA (umeclidinium/vilanterol) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including…
Verbatim from this product's HC label. Tap a section to expand.
, chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. • As with other inhaled drugs containing beta2-adrenergic agents, ANORO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing a long-acting beta-adrenergic agonist or a long-acting muscarinic antagonist, as an overdose may result.
, 4 times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. • Patients should be made aware that for optimum benefit, ANORO ELLIPTA must be used regularly, even when asymptomatic.
5/25 mcg once daily. 3 PHARMACOKINETICS, Special Populations and Conditions, Geriatrics). Pediatrics ANORO ELLIPTA should not be used in patients under 18 years of age. Hepatic Insufficiency No dosage adjustment is required for patients with mild or moderate hepatic impairment.
3 PHARMACOKINETICS, PrANORO ELLIPTA (umeclidinium/vilanterol) Page 6 of 38 Special Populations and Conditions, Hepatic Insufficiency). 3 PHARMACOKINETICS, Special Populations and Conditions, Renal Insufficiency). 4 Administration ANORO ELLIPTA is for oral inhalation only.
ANORO ELLIPTA should be administered once-daily at the same time of the day each day. 5 Missed Dose If a dose is missed, the patient should be instructed to take the next dose when it is due. The patient should not be instructed to take an extra dose.
1 Adverse Reaction Overview Long-acting beta2-adrenergic agonists such as vilanterol, one of the active ingredients of ANORO ELLIPTA increase the risk of asthma-related death. ANORO ELLIPTA is not indicated for the treatment of asthma (See 1 INDICATIONS and 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
ANORO ELLIPTA is a combination of a long-acting muscarinic antagonist and a long-acting beta2-agonist. Adverse reactions to ANORO ELLIPTA are expected to be similar in nature to other muscarinic antagonists and beta2-agonists. Adverse reactions that have been associated with other muscarinic antagonists include cardiovascular effects (atrial arrhythmias and tachycardia), ocular disorders (blurred vision), urinary retention, gastrointestinal disorders, dry mouth and cough.
Adverse reactions that have been associated with other beta2-agonists include immediate hypersensitivity reactions (urticaria, rash, bronchospasm, edema, angioedema, and anaphylactic shock or anaphylactic reaction), cardiovascular effects (tachycardia, arrhythmia, palpitations, myocardial ischemia, angina pectoris, hypertension or hypotension), hypokalemia, hyperglycemia, and metabolic acidosis, headache, nervousness, insomnia, PrANORO ELLIPTA (umeclidinium/vilanterol) Page 12 of 38 dizziness, nausea, muscle spasms, fatigue, malaise, and tremor.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 5/25 mcg or greater for up to one year during clinical studies. 5/25 mcg and 1,330 patients who received 125/25 mcg, all once-daily.
, General). 1 Pediatrics Pediatrics (<18 years of age): ANORO ELLIPTA should not be used in patients under 18 years of age. 2 Geriatrics Geriatrics (≥65 years of age): No dosage adjustment is required in patients 65 years of age and older.
2 CONTRAINDICATIONS • ANORO ELLIPTA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• ANORO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins, see 7 WARNINGS AND PRECAUTIONS, Immune. • All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication (see 7 WARNINGS AND PRECAUTIONS, General, 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
PrANORO ELLIPTA (umeclidinium/vilanterol) Page 5 of 38 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ASTHMA-RELATED DEATH Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to patients’ usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol.
This finding with salmeterol is considered a class effect of LABA, including vilanterol, one of the active ingredients in ANORO ELLIPTA. ANORO ELLIPTA is only indicated for COPD. The safety and efficacy of ANORO ELLIPTA in patients with asthma have not been established.
ANORO ELLIPTA is therefore not indicated for the treatment of asthma. , chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage.
• As with other inhaled drugs containing beta2-adrenergic agents, ANORO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing a long-acting beta-adrenergic agonist or a long-acting muscarinic antagonist, as an overdose may result.
and 7 WARNINGS AND PRECAUTIONS, General). 1 Pediatrics Pediatrics (<18 years of age): ANORO ELLIPTA should not be used in patients under 18 years of age. 2 Geriatrics Geriatrics (≥65 years of age): No dosage adjustment is required in patients 65 years of age and older.
2 CONTRAINDICATIONS • ANORO ELLIPTA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• ANORO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins, see 7 WARNINGS AND PRECAUTIONS, Immune. • All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication (see 7 WARNINGS AND PRECAUTIONS, General,
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients were excluded from clinical studies if they had clinically significant cardiovascular abnormalities that were uncontrolled or a significant ECG finding from the 12-lead ECG conducted at the study entry. 24-week studies A total of 1,674 subjects (518 females and 1,156 males) with COPD were treated once daily with ANORO ELLIPTA or umeclidinium/vilanterol 125/25 mcg.
Other treatments included the individual components (umeclidinium or vilanterol), placebo, or active comparator (tiotropium bromide). Table 2 shows all adverse events that occurred with a frequency of equal to or greater than 1% in patients receiving ANORO ELLIPTA in the four 24-week well-controlled studies where the rates in patients receiving ANORO ELLIPTA exceeded placebo.
5 mcg (n=418) Vilanterol 25 mcg (n=1,034) % % % % Infections and Infestations Pharyngitis Sinusitis Lower respiratory tract infection <1 <1 <1 2 1 1 1 <1 <1 2 1 <1 Gastrointestinal Disorders Diarrhea Constipation 1 <1 2 1 <1 <1 2 <1 Musculoskeletal and Connective Tissue Disorders Pain in extremity Muscle spasms Neck pain 1 <1 <1 2 1 1 <1 <1 <1 2 <1 <1 General disorders and administration site conditions Chest pain <1 1 <1 <1 Studies DB2113361, DB2113373, DB2113360, and DB2113374 Incidence boundaries are applied prior to rounding percentages for presentation in the table.
12-month study In a long-term safety study, 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 study were PrANORO ELLIPTA (umeclidinium/vilanterol) Page 13 of 38 similar to those of the placebo-controlled efficacy studies.
Patients with an abnormal/significant ECG finding or 24-hour Holter monitoring finding during the study withdrew from the study. Adverse events that occurred with a frequency of equal to or greater than 1% in the group receiving 125/25 mcg and exceeded placebo in this study were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, respiratory tract infection viral, toothache and diabetes mellitus.
3 Less Common Clinical Trial Adverse Reactions (<1%) Cardiac disorders: atrial fibrillation, atrial flutter, ECG PR prolongation, increased heart rate, palpitation, tachycardia, supraventricular extrasystoles, supraventricular tachycardia (SVT), ectopic supraventricular rhythm, and cardiac ischemia.
Gastrointestinal disorders: dry mouth. Respiratory, Thoracic and Mediastinal Disorders: cough. 5 Post-Market Adverse Reactions The following relevant adverse reactions have been identified from post-approval use of ANORO ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity reactions including rash (uncommon), anaphylaxis (rare), angioedema (rare), and urticaria (rare) Psychiatric Disorders: anxiety (uncommon) Nervous System Disorders: tremor (uncommon), dysgeusia (uncommon) Eye Disorders: vision blurred (rare), glaucoma (rare), intraocular pressure increased (rare), eye pain (rare) Respiratory, Thoracic and Mediastinal Disorders: paradoxical bronchospasm (rare), dysphonia (rare) Renal and Urinary Disorders: urinary retention (rare), dysuria (rare)
, 4 times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. • Patients should be made aware that for optimum benefit, ANORO ELLIPTA must be used regularly, even when asymptomatic.
5/25 mcg once daily. 3 PHARMACOKINETICS, Special Populations and Conditions, Geriatrics). Pediatrics ANORO ELLIPTA should not be used in patients under 18 years of age. Hepatic Insufficiency No dosage adjustment is required for patients with mild or moderate hepatic impairment.
3 PHARMACOKINETICS, PrANORO ELLIPTA (umeclidinium/vilanterol) Page 6 of 38 Special Populations and Conditions, Hepatic Insufficiency). 3 PHARMACOKINETICS, Special Populations and Conditions, Renal Insufficiency). 4 Administration ANORO ELLIPTA is for oral inhalation only.
ANORO ELLIPTA should be administered once-daily at the same time of the day each day. 5 Missed Dose If a dose is missed, the patient should be instructed to take the next dose when it is due. The patient should not be instructed to take an extra dose.
5 OVERDOSAGE No data from clinical studies are available regarding overdose with ANORO ELLIPTA. , myocardial ischemia, hypertension or hypotension, tremor, headache, tachycardia, QTc prolongation, arrhythmias, palpitation, dizziness, nervousness, insomnia, anxiety, muscle spasms, nausea, fatigue, seizures, malaise, hypokalemia, hyperglycemia, and metabolic acidosis).
As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of vilanterol. If overdose occurs, discontinue ANORO ELLIPTA and initiate appropriate symptomatic and/or supportive therapy.
Cardiac monitoring including electrocardiogram monitoring is recommended in cases of overdosage. For management of a suspected drug overdose, contact your regional poison control centre. PrANORO ELLIPTA (umeclidinium/vilanterol) Page 7 of 38 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging ANORO ELLIPTA is supplied as a disposable grey and red plastic inhaler containing 2 double-foil strips.
5 mcg of umeclidinium) and each blister on the other strip contains a white powder mix of micronized vilanterol trifenatate (40 mcg, equivalent to 25 mcg vilanterol). The inhaler is packaged within a moisture-protective foil laminate tray with a desiccant and a peelable foil lid.
ANORO ELLIPTA is supplied with either 30 or 7 blisters on each double-foil strip. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time. 7 WARNINGS AND […]