Efficacy and safety
Efficacy of Anoro Ellipta1
See the Summary of Product Characteristics for a more detailed overview of the efficacy for Anoro Ellipta.
Safety of Anoro Ellipta1
The safety profile of Anoro Ellipta is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed in the integration of five 24-week studies and in the 12 month safety study.
|Very common adverse events (≥1/10)||-|
|Common adverse events (≥1/100 to <1/10)||Urinary tract infection, sinusitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, constipation and dry mouth|
|Uncommon (≥1/1,000 to <1/100)||
Hypersensitivity reactions including rash; atrial fibrillation, supraventricular tachycardia, rhythm idioventricular, tachycardia, supraventricular extrasystoles, palpitations, rash, tremor, dysgeusia
|Rare adverse events (≥1/10,000 to <1/1,000)||Hypersensitivity reactions including anaphtyaxis, angioedema, urticaria, and blurred vision.
Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate and magnesium stearate).1
Special warnings and precautions for use1
Anoro Ellipta should not be used in patients with asthma. Treatment with Anoro Ellipta should be discontinued in the event of paradoxical bronchospasm and alternative therapy initiated if necessary.
Cardiovascular effects may be seen after the administration of muscarinic receptor antagonists and sympathomimetics therefore Anoro Ellipta should be used with caution in patients with severe cardiovascular disease.
Anoro Ellipta should be used with caution in patients with urinary retention, narrow angle glaucoma, convulsive disorders, thyrotoxicosis, hypokalaemia, hyperglycaemia and severe hepatic impairment. No dosage adjustment is required in renal or mild to moderate hepatic impairment.
Anoro Ellipta is not indicated for acute episodes of bronchospasm. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Pregnancy and breast‐feeding1
No available data. Balance risks against benefits.
Interactions of Anoro Ellipta with other medicinal products1
Interaction studies have only been performed in adults. Avoid β-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin). Anoro Ellipta should not be used in conjunction with other long-acting β2-adrenergic agonists or medicinal products containing long-acting muscarinic antagonists.
Caution is advised with concomitant use with methylxanthine derivatives, steroids or non-potassium-sparing diuretics as it may potentiate possible hypokalaemic effect of β2-adrenergic agonists.