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Revinty Ellipta is a brand name for Vilanterol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Asthma Revinty Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: • patients not adequately controlled with inhaled corticosteroids and 'as needed'…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Asthma Patients with asthma should be given the strength of Revinty Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.
3 Adults and adolescents aged 12 years and over A starting dose of one inhalation of Revinty Ellipta 92/22 micrograms once daily should be considered for adults and adolescents 12 years and over who require a low to mid dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
If patients are inadequately controlled on Revinty Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control. Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Revinty Ellipta 184/22 micrograms should be considered for adults and adolescents 12 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
Patients usually experience an improvement in lung function within 15 minutes of inhaling Revinty Ellipta. However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief. Children aged under 12 years The safety and efficacy of Revinty Ellipta in children under 12 years of age have not been established in the indication for asthma.
Revinty Ellipta should not be used in children under 12 years of age. 2. COPD Adults aged 18 years and over One inhalation of Revinty Ellipta 92/22 micrograms once daily. Revinty Ellipta 184/22 micrograms is not indicated for patients with COPD.
8). Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Revinty Ellipta. Paediatric population There is no relevant use of Revinty Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Summary of the safety profile Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with fluticasone furoate/vilanterol. In the asthma clinical development programme a total of 7,034 patients were included in an integrated assessment of adverse reactions.
In the COPD clinical development programme a total of 6,237 subjects were included in an integrated assessment of adverse reactions. The most commonly reported adverse reactions with fluticasone furoate and vilanterol were headache and nasopharyngitis.
With the exception of pneumonia and fractures, the safety profile was similar in patients with asthma and COPD. During clinical studies, pneumonia and fractures were more frequently observed in patients with COPD. Tabulated list of adverse reactions Adverse reactions are listed by system organ class and frequency.
The following convention has been used for the classification of frequencies: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System organ class Adverse reaction(s) Frequency Infections and infestations Pneumonia* Upper respiratory tract infection Bronchitis Influenza Candidiasis of mouth and throat Common Immune system disorders Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
3 in the VI 22 micrograms group. 1 with VI 22 micrograms. 5 for FF/VI 92/22 micrograms and 0 for VI 22 micrograms. 4) respectively. 0 in the placebo group. **Fractures In two replicate 12 month studies in a total of 3,255 patients with COPD the incidence of bone fractures overall was low in all treatment groups, with a higher incidence in all Revinty Ellipta groups (2%) compared with the vilanterol 22 micrograms group (<1%).
Deterioration of disease Fluticasone furoate/vilanterol should not be used to treat acute asthma symptoms or an acute exacerbation in COPD, for which a short-acting bronchodilator is required. Increasing use of short- Your lips fit over the contoured shape of the mouthpiece for inhaling.
Do not block the air vent with your fingers. 7 acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician. Patients should not stop therapy with fluticasone furoate/vilanterol in asthma or COPD, without physician supervision since symptoms may recur after discontinuation.
Asthma-related adverse events and exacerbations may occur during treatment with fluticasone furoate/vilanterol. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with Revinty Ellipta.
Paradoxical bronchospasm Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a short-acting inhaled bronchodilator. Revinty Ellipta should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Revinty Ellipta. 1). However, fluticasone furoate/vilanterol should be used with caution in patients with severe cardiovascular disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
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. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2). 2). 2). Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids. 4). Method of administration Revinty Ellipta is for oral inhalation only.
It should be administered at the same time of the day, each day. The final decision on evening or morning dosing should be left to the discretion of the physician. After inhalation, patients should rinse their mouth with water without swallowing.
If a dose is missed the next dose should be taken at the usual time the next day. If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use. When the inhaler is used for the first time, there is no need to check that it is working properly, and to prepare it for use in any special way.
The step-by-step instructions should be followed. The Ellipta inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled. The patient should be advised to not open the tray until they are ready to inhale a dose.
When the inhaler is taken out of its tray, it will be in the ‘closed’ position. The “Discard by” date should be written on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date of opening the tray. After this date the inhaler should no longer be used.
The tray can be discarded after first opening. The step-by-step instructions shown below for the 30-dose Ellipta inhaler (30 day supply) also apply to the 14-dose Ellipta inhaler (14 day supply). Instructions for use 1. Read this before you start If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take extra medicinal product or a double dose in one inhalation. 5 2. Prepare a dose Open the cover when ready to inhale a dose.
The inhaler should not be shaken. Slide the cover down 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.
3. 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 lips and the lips should be then closed firmly around it.
The air vents […]
, spinal compression/thoracolumbar vertebral fractures, hip and acetabular fractures) occurred in <1% of the Revinty Ellipta and vilanterol treatment arms. For the SUMMIT study, the incidence of all events of fracture with FF/VI, FF, VI and placebo were 2% in each arm; fractures commonly associated with ICS use were less than 1 % in each arm.
1 respectively. In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of fractures was <1%, and usually associated with trauma. System organ class Adverse reaction(s) Frequency Musculoskeletal and connective tissue disorders Arthralgia Back pain Fractures** Muscle spasms Common General disorders and administration site conditions Pyrexia Common 12 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.
Fluticasone furoate/vilanterol should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections. 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.
8 Hyperglycaemia There have been reports of increases in blood glucose levels in diabetic patients and this should be considered when prescribing to patients with a history of diabetes mellitus. 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.
Pneumonia in patients with asthma The incidence of pneumonia in patients with asthma was common at the higher dose. 8). No risk factors were identified. Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.