RELVAR ELLIPTA INHALATION POWDER 100MCG/25MCG

POWDER, METERED

**Dosage and Administration** Pharmaceutical form: Inhalation powder. _RELVAR ELLIPTA_ is for inhalation only. _RELVAR ELLIPTA_ should be administered once daily either morning or evening but at the same time every day. If a dose is missed, the next dose should be taken at the usual time the next day. After inhalation, the patient should rinse their mouth with water without swallowing. **ASTHMA** Patients should be made aware that _RELVAR ELLIPTA_ must be used regularly, even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief. Patients should be regularly reassessed by a healthcare professional so that the strength of _RELVAR ELLIPTA_ they are receiving remains optimal and is only changed on medical advice. **Populations** **Adults and adolescents aged 12 years and over** The recommended dose of _RELVAR ELLIPTA_ is: One inhalation of _RELVAR ELLIPTA_ 100/25 micrograms once daily or One inhalation of _RELVAR ELLIPTA_ 200/25 micrograms once daily A starting dose of _RELVAR ELLIPTA_ 100/25 micrograms should be considered for patients who require a low to mid-dose of inhaled corticosteroid in combination with a long-acting beta2-agonist. _RELVAR ELLIPTA_ 200/25 micrograms should be considered for patients who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist. If patients are inadequately controlled on _RELVAR ELLIPTA_ 100/25 micrograms, consider increasing the dose to 200/25 micrograms, which may provide additional improvement in asthma control. **Children** The safety and efficacy of _RELVAR ELLIPTA_ has not been established in children less than 12 years of age. **COPD** **Populations** **Adults** The recommended dose of _RELVAR ELLIPTA_ is: One inhalation of _RELVAR ELLIPTA_ 100/25 micrograms once daily. _RELVAR ELLIPTA_ 200/25 micrograms is not indicated for patients with COPD. There is no additional benefit of the 200/25 micrograms dose compared to the 100/25 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions. **Children** The use in children is not relevant for COPD indication for this product. **Special population: Asthma and COPD** **Elderly** No dosage adjustment is required in patients over 65 years (see _Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal impairment** No dose adjustment is required for patients with renal impairment (see _Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic Impairment** A clinical pharmacology study in subjects with mild, moderate and severe hepatic impairment showed up to 3-fold increase in systemic exposure to fluticasone furoate (AUC) (see _Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 100/25 micrograms (see _Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).