Elebrato Ellipta

HOS-098727 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile The most frequently reported adverse reactions are nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%). Tabulated list of adverse reactions The safety profile of Elebrato Ellipta is based on three phase III clinical studies and spontaneous reporting. Where adverse reaction frequencies differed between studies, the higher frequency is reported below. Adverse reactions are listed by MedDRA system organ class. The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from available data). 7  System Organ Class Adverse reactions Frequency Infections and infestations Pneumonia Common Upper respiratory tract infection Bronchitis Pharyngitis Rhinitis Sinusitis Influenza Nasopharyngitis Candidiasis of mouth and throat Urinary tract infection Viral respiratory tract infection Uncommon Immune system disorders Hypersensitivity reactions, including Rare anaphylaxis, angioedema, urticaria, and rash Metabolism and nutrition Hyperglycaemia Rare disorders Psychiatric disorders Anxiety Rare Nervous system disorders Headache Common Dysgeusia Uncommon Tremor Rare Eye disorders Vision blurred (see section 4.4) Uncommon Glaucoma Eye pain Intraocular pressure increased Rare Cardiac disorders Supraventricular tachya

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HOS-098723 · has-contraindication-information · PDF-Seite 3

3 Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

HOS-098722 · has-indication-information · PDF-Seite 2

Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).

HOS-098725 · has-interaction-information · PDF-Seite 6

Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing. Interaction with beta-blockers Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol. If beta-blockers are required, cardioselective beta-blockers should be considered, however, caution should be exercised during concurrent use of both non-selective and selective beta-blockers. Interaction with CYP3A4 inhibitor Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme CYP3A4. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, which could lead to an increased potential for adverse reactions. Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions, in which case patients should be monitored for systemic corticosteroid adverse reactions. A repeat dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor). Co-administration increased mean fluticasone furoate AUC(0-24) and Cmax by 36% and 33%, respectively. The increase in fluticasone furoate exposure was associated with a 27% reduction in 0-24 hours weighted mean serum cortisol. Co-administration increased mean vilanterol AUC(0-t) and Cmax by 65% and 22%, respectively. The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate or blood potassium. Interaction with CYP2D6 inhibitors/CYP2D6 polymorphism Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers). No effect on umeclidinium AUC or Cmax was observed at a dose 8-fold higher than the therapeutic dose. An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax. Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administere

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HOS-098726 · has-pregnancy-information · PDF-Seite 7

Pregnancy There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women. Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3). Administration of Elebrato Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus. Breast-feeding It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk. However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue Elebrato Ellipta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility. Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3).

HOS-098724 · has-warning-information · PDF-Seite 4

Asthma This medicinal product should not be used in patients with asthma since it has not been studied in this patient population. Not for acute use There are no clinical data to support the use of Elebrato Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy). Deterioration of disease Increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control. In the event of deterioration of COPD during treatment with Elebrato Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. Patients should not stop therapy with Elebrato Ellipta without physician supervision since symptoms may recur after discontinuation. Paradoxical bronchospasm Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening. If paradoxical bronchospasm occurs, treatment should be discontinued immediately. The patient should be assessed and alternative therapy instituted if necessary. Cardiovascular effects Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively (see section 4.8). Therefore, Elebrato Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease. Patients with hepatic impairment Patients with moderate to severe hepatic impairment receiving Elebrato Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2). Systemic corticosteroid effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Coexisting conditions

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