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Elebrato Ellipta is a brand name for Umeclidinium. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting…
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended and maximum dose is one inhalation once daily, each day at the same time. If a dose is missed the next dose should be inhaled at the usual time the next day. 2). 2). Hepatic impairment 3 No dose adjustment is required in patients with mild, moderate or severe hepatic impairment.
2). Paediatric population There is no relevant use of Elebrato Ellipta in the paediatric population (under 18 years of age) for the indication of COPD. Method of administration For inhalation use only.
Instructions for use:
The following instructions for the 30 dose (30 day supply) inhaler also apply to the 14 dose (14 day supply) inhaler. a) Prepare a dose Open the cover when ready to inhale a dose. The inhaler should not be shaken. Slide the cover down fully until a “click” is heard.
The medicinal product is now ready to be inhaled. The dose counter counts down by 1 to confirm. If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
b) How to inhale the medicinal product The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler. The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
The air vents should not be blocked with fingers during use. • Inhale with one long, steady, deep breath in. This breath should be held in for as long as possible (at least 3-4 seconds). • Remove the inhaler from the mouth. • Breathe out slowly and gently.
The medicinal product may not be tasted or felt, even when using the inhaler correctly. The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover. c) Close the inhaler and rinse your mouth Slide the cover upwards as far as it will go, to cover the mouthpiece.
Rinse your mouth with water after you have used the inhaler, do not swallow. This will make it less likely to develop a sore mouth or throat as side effects. 6.
Summary of the safety profile The most frequently reported adverse reactions are nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%). Tabulated list of adverse reactions The safety profile of Elebrato Ellipta is based on three phase III clinical studies and spontaneous reporting.
Where adverse reaction frequencies differed between studies, the higher frequency is reported below. Adverse reactions are listed by MedDRA system organ class. The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from available data).
4) Glaucoma Eye pain Uncommon Intraocular pressure increased Rare Cardiac disorders Supraventricular tachyarrhythmia Tachycardia Atrial fibrillation Uncommon Palpitations Rare Respiratory, thoracic & mediastinal disorders Cough Oropharyngeal pain Common Dysphonia Uncommon Gastrointestinal disorders Constipation Common Dry mouth Uncommon Musculoskeletal and connective tissue disorders Arthralgia Back pain Common Fractures Uncommon Muscle spasms Rare Renal and urinary disorders Urinary retention Dysuria Rare Description of selected adverse reactions Pneumonia In a total of 1 810 patients with advanced COPD (mean post bronchodilatory screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Elebrato Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Pneumonia which required hospitalisation occurred in 1% of patients receiving Elebrato Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks. One fatal case of pneumonia was reported in a patient who received Elebrato Ellipta.
Asthma This medicinal product should not be used in patients with asthma since it has not been studied in this patient population. e. as a rescue therapy). Deterioration of disease Increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control.
In the event of deterioration of COPD during treatment with Elebrato Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. Patients should not stop therapy with Elebrato Ellipta without physician supervision since symptoms may recur after discontinuation.
Paradoxical bronchospasm Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening. If paradoxical bronchospasm occurs, treatment should be discontinued immediately.
The patient should be assessed and alternative therapy instituted if necessary. g. 8). Therefore, Elebrato Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease. 2). Systemic corticosteroid effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
These effects are much less likely to occur than with oral corticosteroids. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Coexisting conditions 5 Elebrato Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists. Elebrato Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Elebrato Ellipta and budesonide/formoterol arms was equal at 2%. The incidence of pneumonia with Elebrato Ellipta is 9 comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
In a 52-week study, with a total of 10 355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Elebrato Ellipta (n = 4 151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4 134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2 070).
9 per 1 000 patient-years) receiving umeclidinium/vilanterol. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Anticholinergic activity Elebrato Ellipta should be used with caution in patients with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Elebrato Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
g. benign prostatic hypertrophy. 8). Pneumonia in patients with COPD An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
The decrease in serum potassium is usually transient, not requiring supplementation. No clinically relevant effects of hypokalaemia were observed in clinical studies with Elebrato Ellipta at the recommended therapeutic dose. 5). Hyperglycaemia Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients.
No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose. 8). Upon initiation of treatment with Elebrato Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product. 6