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INCRUSE 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: INCRUSE ELLIPTA (umeclidinium) is indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. INCRUSE ELLIPTA is not indicated for the relief of acute deterioration of COPD.…
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. • INCRUSE ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing 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, INCRUSE ELLIPTA must be used regularly, even when asymptomatic.
5 mcg once daily. Geriatrics No dosage adjustment is required in patients 65 years of age and older. Pediatrics INCRUSE ELLIPTA should not be used in patients under 18 years of age. Hepatic Insufficiency No dosage adjustment is required in patients with mild or moderate hepatic impairment.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). Renal Insufficiency No dosage adjustment is required in patients with renal impairment. 4 Administration INCRUSE ELLIPTA is for oral inhalation only. INCRUSE 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 INCRUSE ELLIPTA contains a long-acting muscarinic antagonist. Adverse reactions to INCRUSE ELLIPTA are expected to be similar in nature to other muscarinic antagonists. 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.
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. 7, 89% white, 65% male; across all treatment arms, including placebo). 5 mcg. In a randomized, double-blind, placebo-controlled long-term safety study, 227 subjects received umeclidinium 125 mcg for up to 52 weeks.
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. 12-week and 24-week pivotal studies The incidence of adverse events presented in Table 2 is based upon two pivotal placebo-controlled efficacy studies: one 12-week study and one 24-week study.
Adverse events in subjects receiving INCRUSE ELLIPTA reported with a frequency of equal to or greater than 1%, and exceeding the rate in subjects receiving placebo are listed in Table 2. 3 Less Common Clinical Trial Adverse Drug Reactions (<1%) Cardiac disorders: atrial fibrillation.
Gastrointestinal disorders: constipation. Infections and Infestations: sinusitis. 52-week study In a long-term safety study, 336 subjects (n=227 umeclidinium 125 mcg, n=109 placebo) were treated for up to 52 weeks with umeclidinium 125 mcg or placebo.
, Immune. , 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. • INCRUSE ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing 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, INCRUSE ELLIPTA must be used regularly, even when asymptomatic.
5 mcg once daily. Geriatrics No dosage adjustment is required in patients 65 years of age and older. Pediatrics INCRUSE ELLIPTA should not be used in patients under 18 years of age. Hepatic Insufficiency No dosage adjustment is required in patients with mild or moderate hepatic impairment.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). Renal Insufficiency No dosage adjustment is required in patients with renal impairment. 4 Administration INCRUSE ELLIPTA is for oral inhalation only. INCRUSE 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 INCRUSE ELLIPTA.
, dry mouth, visual accommodation disturbances and tachycardia). 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.
If overdose occurs, discontinue INCRUSE ELLIPTA and initiate appropriate symptomatic and/or supportive therapy. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Inhalation Dry powder for oral Lactose monohydrate (which contains milk protein) and magnesium stearate PrINCRUSE ELLIPTA (umeclidinium) Page 6 of 30 INCRUSE ELLIPTA is supplied as a disposable grey and light green plastic inhaler containing a foil strip.
• INCRUSE 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.
• INCRUSE ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins, see 7 WARNINGS AND PRECAUTIONS, Immune.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The demographic and baseline characteristics of the long-term safety study were similar to those of the efficacy studies. Patients with an abnormal/significant ECG finding or from 24-hour Holter monitoring finding during the study withdrew from the study.
The adverse events reported in subjects receiving umeclidinium 125 mcg with a frequency of equal to or greater than 1% and exceeding the rate in subjects receiving placebo in this study were: upper respiratory tract infection, pharyngitis, pneumonia, lower respiratory tract infection, rhinitis, headache, dizziness, sinus headache, cough, back pain, arthralgia, pain in extremity, neck pain, myalgia, nausea, dyspepsia, diarrhea, rash, depression, vertigo, nasopharyngitis, supraventricular extrasystoles, sinus tachycardia, supraventricular tachycardia, rhythm idioventricular, and urinary tract infection.
5 mcg (n=487) % Placebo (n=348) % Infections and Infestations Nasopharyngitis 8 7 Upper respiratory tract infection 5 4 Viral upper respiratory tract infection 1 <1 Pharyngitis 1 <1 Respiratory, thoracic, and mediastinal disorders Cough 3 2 Injury, poisoning and procedural complications Contusion 1 <1 Musculoskeletal and Connective Tissue Disorders Arthralgia 2 1 Myalgia 1 <1 Gastrointestinal disorders Abdominal pain upper 1 <1 Toothache 1 <1 Cardiac disorders Tachycardia 1 <1 PrINCRUSE ELLIPTA (umeclidinium) Page 11 of 30 12-week additional studies The safety of INCRUSE ELLIPTA in combination with an inhaled corticosteroid/long-acting beta2- adrenergic agonist (ICS/LABA) was evaluated in four 12-week clinical trials.
2 Pharmacodynamics, Clinical Pharmacology). Two trials evaluated INCRUSE ELLIPTA in combination with fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg administered once daily; and 2 trials evaluated INCRUSE ELLIPTA administered once daily in combination with fluticasone propionate/salmeterol (FP/SAL) 250 mcg/50 mcg administered twice daily.
Adverse reaction profiles seen in these four 12-week studies were similar to that observed in pivotal studies and the 52-week long-term study. Adverse reactions occurring with INCRUSE ELLIPTA in combination with an ICS/LABA, at an incidence of greater than or equal to 1% and exceeding ICS/LABA alone were oropharyngeal pain and dysgeusia.
5 Post-Market Adverse Reactions The following adverse reactions have been identified from post-approval use of INCRUSE 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.
Nervous System Disorders: dysgeusia (common) Immune System Disorders: hypersensitivity reactions including: rash, urticaria and pruritus (uncommon); anaphylaxis (rare), angioedema (rare) Eye Disorders: vision blurred (unknown), eye pain (unknown), glaucoma (unknown) Respiratory, thoracic and mediastinal disorders: Dysphonia (rare), […]
5 mcg of umeclidinium). The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid. INCRUSE ELLIPTA is supplied with either 30 or 7 blisters on each strip. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time.
, as rescue therapy. INCRUSE ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. The initiation of INCRUSE ELLIPTA in this setting is not appropriate. An inhaled, short-acting bronchodilator, should be used to relieve acute symptoms such as shortness of breath.
When prescribing INCRUSE ELLIPTA, the physician must also provide the patient with an inhaled, short-acting bronchodilator for treatment of acute symptoms. Patients should be advised to have their short-acting bronchodilator available at all times.
, 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. COPD may deteriorate acutely over a period of hours or chronically over several days or longer.
If INCRUSE ELLIPTA no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting bronchodilator becomes less effective or the patient needs more inhalation of a short-acting bronchodilator than usual, these may be markers of deterioration of disease.
In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of INCRUSE ELLIPTA beyond the recommended dose is not appropriate in this situation. Exacerbations may occur during treatment with INCRUSE ELLIPTA.
Patients should be advised to continue treatment and seek medical advice if COPD symptoms remain uncontrolled or worsen after initiation of therapy with INCRUSE ELLIPTA. • Excessive Use As with other inhaled bronchodilators, INCRUSE ELLIPTA should not be used more often or at higher doses than recommended.
, ipratropium, tiotropium, glycopyrronium, aclidinium), as an […]