RELVAR ELLIPTA INHALATION POWDER 100MCG/25MCG [SIN14736P]

Product Info

RELVAR ELLIPTA INHALATION POWDER 100MCG/25MCG

[SIN14736P]

Indications

ASTHMA

RELVAR 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” inhaled short-acting beta₂-agonists

• patients already adequately controlled on both inhaled corticosteroid and long-acting beta₂-agonist

COPD

RELVAR 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.

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).

Contraindications

RELVAR ELLIPTA is contraindicated in patients with severe milk-protein allergy or who have demonstrated hypersensitivity to either RELVAR ELLIPTA or any of the excipients.