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Efficacy and safety

Efficacy of Relvar Ellipta [1][2]

For a detailed overview of the efficacy for Relvar please refer to the Summary of Product Characteristics

Safety of Relvar Ellipta [1][2]

Adverse Event Table

Relvar▼(fluticasone furoate/vilanterol) Safety Profile

Frequency of adverse event

Adverse Event

Very common adverse
reactions (≥1/10)

Headache, nasopharyngitis


Common adverse reactions

(≥1/100 to <1/10)




 

Pneumonia, upper respiratory tract infection, bronchitis, influenza, candidiasis of mouth and throat, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia, abdominal pain, arthralgia, back pain, fractures, muscle spasms, pyrexia

Other important adverse reactions include

Frequency: Uncommon (≥1/1,000 to <1/100)

Frequency: Rare (≥1/10,000 to <1/1,000)

Vision blurred
Paradoxical bronchospasm, hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria
Considerations











 

Please consult the full Summary of Product Characteristics for further information and guidance on discontinuation of treatment and/or appropriate patient referral in the event of disease deterioration, paradoxical bronchospasm, cardiovascular effects, hyperglycaemia, systemic steroid effects, visual disturbance, psychological effects, pneumonia and use in hepatic impairment.

Relvar Ellipta 184/22 micrograms is not indicated for patients with COPD. There is no additional benefit compared with 92/22 mcg and there is a potential increased risk of adverse reactions

Contraindications

Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate).[1] [2]

Special warnings and precautions for use[1] [2]

Please see the safety table above

Acute Symptoms[1] [2]

Not for acute symptoms, use short acting inhaled bronchodilator. Warn patients to seek medical advice if short‐acting inhaled bronchodilator use increases. Therapy should not be abruptly stopped without physician supervision due to risk of symptom recurrence. Asthma‐related adverse events and exacerbations may occur during treatment. Patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Relvar Ellipta.

Systemic Effects[1] [2]

Systemic effects of inhaled corticosteroids may occur, particularly at high doses for long periods, but much less likely 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, glaucoma or central serous chorioretinopathy (CSCR). More rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Increased incidence of pneumonia has been observed in patients with COPD receiving Relvar Ellipta.

Risk factors for pneumonia include: current smokers, patients with a history of prior pneumonia, patients with a body mass index <25 kg/m2 and patients with a FEV1<50% predicted. If pneumonia occurs with Relvar Ellipta treatment should be re‐evaluated. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose‐galactose malabsorption should not take this medicinal product.

Pregnancy and breast-feeding[1] [2]

Experience limited. Balance risks against benefits.

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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to GlaxoSmithKline UK on 0800 221 441.

Relvar, Incruse and Ellipta are registered trademarks of the GlaxoSmithKline group of companies