Posology
Asthma
Adults and adolescents aged 12 years and over
One inhalation of Relvar Ellipta 92/22 micrograms once daily.
Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar 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 taken for immediate relief.
A starting dose of Relvar Ellipta 92/22 micrograms 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 Relvar 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.
Relvar 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 with asthma should be given the strength of Relvar 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.
Children aged under 12 years
The safety and efficacy of Relvar Ellipta in children under 12 years of age has not yet been established in the indication for asthma.
No data are available.
COPD
Adults aged 18 years and over
One inhalation of Relvar Ellipta 92/22 micrograms once daily.
Relvar 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 Relvar Ellipta.
Paediatric population
There is no relevant use of Relvar Ellipta in the paediatric population for the indication of COPD.
Special populations
Elderly patients (>65 years)
No dose adjustment is required in this population (see section 5.2).
Renal impairment
No dose adjustment is required in this population (see section 5.2).
Hepatic impairment
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).
Method of administration
Relvar 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.
After inhalation, patients should rinse their mouth with water without swallowing.
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. Once opened the desiccant sachet should be discarded.
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 also apply to the 14-dose Ellipta inhaler.
Instructions for use
1. Read this before you start
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.
2. How to prepare a dose
Open the cover when ready to take 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.
3. How to inhale the medicine
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 bloc
