Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
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:
Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
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.
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.
The safety and efficacy of Revinty Ellipta in children under 12 years of age has not yet been established in the indication for asthma.
No data are available.
One inhalation of Revinty Ellipta 92/22 micrograms once daily.
Revinty Ellipta 184/22 micrograms is not indicated for patients with COPD. There is no additional benefit of the 184/22 micrograms dose compared to the 92/22 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions (see sections 4.4 and 4.8).
Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Revinty Ellipta.
There is no relevant use of Revinty Ellipta in the paediatric population for the indication of COPD.
No dose adjustment is required in this population (see section 5.2).
No dose adjustment is required in this population (see section 5.2).
Studies in subjects with mild, moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate (both Cmax and AUC) (see section 5.2).
Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids.
For patients with moderate or severe hepatic impairment the maximum dose is 92/22 micrograms (see section 4.4).
Revinty Ellipta is for inhalation use 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.
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.
After inhalation, patients should rinse their mouth with water without swallowing.
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).
If the inhaler cover is opened and closed without inhaling the medicine, 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 medicine or a double dose in one inhalation.
Open the cover when ready to inhale a dose. Do not shake the inhaler.
Slide the cover down until you hear a ‘click’.
The medicine is now ready to be inhaled. The dose counter counts down by 1 to confirm.
If the dose counter does not count down as you hear the ‘click’, the inhaler will not deliver medicine. Take it back to a pharmacist for advice.
Hold the inhaler away from your mouth and breathe out as far as is comfortable.
Do not breathe out into the inhaler.
Put the mouthpiece between your lips and close your lips firmly around it.
Do not block the air-vents with your fingers.
Take one long, steady, deep breath in. Hold this breath for as long as possible (at least 3-4 seconds).
It may not be possible to taste or feel the medicine, even when using the inhaler correctly.
If you want to clean the mouthpiece, use a dry tissue, before closing the cover.
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.
An overdose of fluticasone furoate/vilanterol may produce signs and symptoms due to the individual component’s actions, including those seen with overdose of other beta2-agonists and consistent with the known inhaled corticosteroid class effects (see section 4.4).
There is no specific treatment for an overdose with fluticasone furoate/vilanterol. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are clinically concerning and unresponsive to supportive measures. Cardioselective beta-blocking medicinal products should be used with caution in patients with a history of bronchospasm.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
2 years.
In-use shelf-life after opening the tray: 6 weeks.
Do not store above 25°C. If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use.
Store in the original package in order to protect from moisture.
Write the date the inhaler should be discarded on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.
The inhaler consists of a light grey body, a yellow mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable foil lid.
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
The inhaler contains two aluminium foil laminate strips of 14 or 30 doses.
Pack sizes of 14 or 30 dose Inhalers. Multipack of 3 × 30 dose Inhalers.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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