You are now leaving GSK’s website

This link will take you to a non-GSK website. GSK does not recommend, endorse or accept liability for sites controlled by third-parties.

Continue

Go back

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

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: Rare (≥1/10,000 to <1/1,000)

Paradoxical bronchospasm, hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria.

See SmPC for other 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]

Pulmonary tuberculosis, severe cardiovascular disorders or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia, patients predisposed to low levels of serum potassium, chronic or untreated infections, diabetes mellitus. Paradoxical bronchospasm substitute alternative therapy if necessary. In patients with hepatic with moderate to severe impairment 92/22 mcg dose should be used.

Cardiovascular effects, such as cardiac arrhythmias may be seen with sympathomimetic medicinal products including Relvar Ellipta.  Therefore, Relvar Ellipta should be used with caution in patients with severe cardiovascular disease.

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. 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.

Innoviva logo

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