Temybric Ellipta

Posology Adults The recommended and maximum dose is one inhalation of Temybric Ellipta 92/55/22 micrograms once daily, at the same time each day. If a dose is missed the next dose should be inhaled at the usual time the next day. 2).

Hepatic impairment No dose adjustment is required in patients with mild, moderate or severe hepatic impairment. 2). Paediatric population There is no relevant use of Temybric Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.

Method of administration Temybric Ellipta is for inhalation use only.

Instructions for use:

The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler. a) Prepare a dose Open the cover when ready to inhale a dose. The inhaler should not be shaken. Slide the cover down fully until a “click” is heard.

The medicinal product is now ready to be inhaled. The dose counter counts down by 1 to confirm. If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.

b) How to inhale the medicinal product The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler. The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.

The air vents should not be blocked with fingers during use. • Inhale with one long, steady, deep breath in. This breath should be held in for as long as possible (at least 3-4 seconds). • Remove the inhaler from the mouth. • Breathe out slowly and gently.

The medicinal product may not be tasted or felt, even when using the inhaler correctly. Medicinal product no longer authorised 4 c) Close the inhaler and rinse your mouth Slide the cover upwards as far as it will go, to cover the mouthpiece.

Rinse your mouth with water after you have used the inhaler, do not swallow. This will make it less likely to develop a sore mouth or throat as side effects. 6.

Medicinal product no longer authorised 8 Tabulated summary of adverse reactions The safety profile of Temybric Ellipta is based on three phase III clinical studies and spontaneous reporting. The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).

The second study included safety data from 527 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 24 weeks (study 200812).

The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT). Where adverse reaction frequencies differed between studies, the higher frequency is reported below.

Adverse reactions are listed by MedDRA system organ class. 4) Glaucoma Eye pain Uncommon Intraocular pressure increased Rare Cardiac disorders Supraventricular tachyarrhythmia Tachycardia Atrial fibrillation Uncommon Respiratory, thoracic & mediastinal disorders Cough Oropharyngeal pain Common Dysphonia Uncommon Gastrointestinal disorders Constipation Common Dry mouth Uncommon Musculoskeletal and connective tissue disorders Arthralgia Back pain Common Fractures Uncommon Description of selected adverse reactions Pneumonia In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Temybric Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).

Pneumonia which required hospitalisation occurred in 1% of patients receiving Temybric Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks. One fatal case of pneumonia was reported in a patient who received Temybric Ellipta.

In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Temybric Ellipta and budesonide/formoterol arms was equal at 2%. The incidence of pneumonia with Temybric Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.

In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Temybric Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).

9 per 1,000 patient-years) receiving umeclidinium/vilanterol. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Asthma Temybric Ellipta should not be used in patients with asthma since it has not been studied in this patient population. 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 Temybric Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. Patients should not stop therapy with Temybric 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. Treatment with Temybric Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.

The patient should be assessed and alternative therapy instituted if necessary. g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively.

Therefore, Temybric Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease. Medicinal product no longer authorised 5 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 Temybric Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists. Temybric Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.

Anticholinergic activity Temybric Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Temybric Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.

Pneumonia in patients with COPD An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.

There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD. Hypokalaemia Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.

The decrease in serum potassium is usually transient, not requiring supplementation. No clinically relevant effects of hypokalaemia were observed in clinical studies with Temybric Ellipta at the recommended therapeutic dose. Medicinal product no longer authorised 6 Hyperglycaemia Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients.

No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose. There have been reports of increases in blood glucose levels in diabetic patients treated with fluticasone furoate/umeclidinium/vilanterol and this should be considered when prescribing to patients with a history of diabetes mellitus.

Upon initiation of treatment with Temybric Ellipta, plasma glucose should be monitored more closely in diabetic patients. Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.

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