Pulse May 2019 issue - Page 11

Symptomatic COPD patients need to get on with their day SPIOLTO ® Respimat ® is a maintenance bronchodilator for relieving the symptoms of COPD 1 SPIOLTO ® Respimat ® showed statistically signifi cant improvements vs SPIRIVA ® Respimat ® (tiotropium) in lung function*, health-related quality of life † and breathlessness ‡1–4 The Respimat Soft ® Mist™ inhaler requires a low inspiratory eff ort and can be used by a wide range of COPD patients 5,6 Prescribing information for SPIRIVA ® Respimat ® can be found adjacent *In the 52-week trials, SPIOLTO ® Respimat ® administered once daily in the morning provided clear improvement in lung function within 5 minutes after the first dose compared to tiotropium 5 µg (mean increase in FEV 1 of 0.137 L for SPIOLTO ® Respimat ® vs. 0.058 L for tiotropium 5 µg [p<0.0001]). 3 † SPIOLTO ® Respimat ® resulted in statistically significant improvements in SGRQ total scores and responder rates vs. both monotherapies (p<0.05) after 24 weeks. Response defined as a ≥4 change in SGRQ score. Pooled analysis of the pivotal phase III TONADO ® 1 and 2 studies. 3 ‡ As measured by the Transitional Dyspnoea Index (TDI) focal score at 24 weeks. Pooled analysis of the pivotal phase III TONADO ® 1 and 2 replicate studies. 3 An increase in TDI score indicates an improvement in breathlessness. 2 TDI focal score increased by 1.983 units with SPIOLTO ® Respimat ® compared to baseline, 1.627 units with SPIRIVA ® Respimat ® compared to baseline and 0.356 units with SPIOLTO ® Respimat ® compared to SPIRIVA ® Respimat ® (22% improvement vs. SPIRIVA ® Respimat ® ; p<0.05). 3 References: 1. SPIOLTO ® Respimat ® Summary of Product Characteristics. 2. Beeh K-M et al. Pulm Pharmacol Ther 2015;32:53–59. 3. Buhl R et al. Eur Resp J 2015;45:969–979. 4. SPIRIVA ® Respimat ® Summary of Product Characteristics. 5. Fink JB et al. COPD 2013;10:1–13. 6. Ciciliani A et al. The Respiratory Drug Delivery Conference (RDD) 2014. Poster presentation. Prescribing Information (UK) SPIOLTO ® RESPIMAT ® (tiotropium and olodaterol) responsive to sympathomimetic amines; in some patients beta 2 -agonists may produce Inhalation solution containing 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. Action: Inhalation solution significant hypokalaemia; increases in plasma glucose after inhalation of high doses. containing a long acting muscarinic receptor antagonist, tiotropium, and a long acting Caution in planned operations with halogenated hydrocarbon anaesthetics due to beta 2 -adrenergic agonist, olodaterol. Indication: Maintenance bronchodilator treatment increased susceptibility of adverse cardiac effects. Should not be used in conjunction with any other long-acting beta 2 -adrenergic agonists. Immediate hypersensitivity to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dose and Administration: Adults only aged 18 years or over: 5 microgram tiotropium reactions may occur after administration. Should not be used more frequently than and 5 microgram of olodaterol given as two puffs from the Respimat inhaler once daily, at once daily. Interactions: Although no formal in vivo drug interaction studies have the same time of the day. Contraindications: Hypersensitivity to tiotropium or olodaterol been performed, inhaled Spiolto Respimat has been used concomitantly with other or any of the excipients; benzalkonium chloride, disodium edetate, purified water, 1M COPD medicinal products, including short acting sympathomimetic bronchodilators hydrochloric acid (for pH adjustment); atropine or its derivatives e.g. ipratropium or and inhaled corticosteroids without clinical evidence of drug interactions. The co- oxitropium. Warnings and Precautions: Not for use in asthma or for the treatment administration of the component tiotropium with other anticholinergic containing drugs of acute episodes of bronchospasm, i.e. as rescue therapy. Inhaled medicines may has not been studied and therefore is not recommended. Concomitant administration cause inhalation-induced paradoxical bronchospasm. Caution in patients with narrow- of other adrenergic agents (alone or as part of combination therapy) may potentiate the angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Patients should be undesirable effects of Spiolto Respimat. Concomitant treatment with xanthine derivatives, cautioned to avoid getting the spray into their eyes. They should be advised that this may steroids, or non-potassium sparing diuretics may potentiate any hypokalaemic effect of result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, adrenergic agonists. Beta-adrenergic blockers may weaken or antagonise the effect temporary blurring of vision, visual halos or coloured images in association with red eyes of olodaterol. Cardioselective beta-blockers could be considered, although they should from conjunctival congestion and corneal oedema. Should any combination of these be administered with caution. MAO inhibitors, tricyclic antidepressants or other drugs eye symptoms develop, patients should stop using Spiolto Respimat and consult a known to prolong the QTc interval may potentiate the action of Spiolto Respimat on specialist immediately. In patients with moderate to severe renal impairment (creatinine the cardiovascular system. Fertility, pregnancy and lactation: There is a very limited clearance ≤ 50ml/min) use only if the expected benefit outweighs the potential risk. amount of data from the use of tiotropium in pregnant women. For olodaterol no Caution in patients with a history of myocardial infarction during the previous year, clinical data on exposed pregnancies are available. As a precautionary measure, avoid unstable or life-threatening cardiac arrhythmia, hospitalised for heart failure during the use of Spiolto Respimat during pregnancy. Like other beta 2 -adrenergic agonists, the previous year or with a diagnosis of paroxysmal tachycardia (> 100 beats per olodaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. It minute) as these patients were excluded from the clinical trials. In some patients, is not known whether tiotropium and/or olodaterol pass into human breast milk. A like other beta-adrenergic agonists, olodaterol may produce a clinically significant decision on whether to continue/discontinue breast-feeding or to continue/discontinue cardiovascular effect as measured by increases in pulse rate, blood pressure and/or therapy with Spiolto Respimat should be made taking into account the benefit of symptoms. Caution in patients with: cardiovascular disorders, especially ischaemic heart breast-feeding to the child and the benefit of therapy for the woman. Clinical data disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive on fertility are not available for tiotropium or olodaterol or the combination of both cardiomyopathy, hypertension, and aneurysm; convulsive disorders or thyrotoxicosis; components. Effects on ability to drive and use machines: No studies have been known or suspected prolongation of the QT interval (e.g. QT>0.44 s); patients unusually performed. The occurrence of dizziness or blurred vision may influence the ability to drive and use machinery. Undesirable effects: Uncommon (≥ 1/1,000 to <1/100): Dizziness, headache, tachycardia, cough, dysphonia, dry mouth. Rare (≥ 1/10,000 to <1/1,000): Insomnia, vision blurred, atrial fibrillation, palpitations, supraventricular tachycardia, hypertension, laryngitis, pharyngitis, epistaxis, bronchospasm, constipation, oropharyngeal candidiasis, gingivitis, nausea, stomatitis, hypersensitivity, angioedema, urticaria, pruritus, rash, arthralgia, back pain, joint swelling, urinary retention, urinary tract infection, dysuria. Not known (cannot be estimated from the available data): Nasopharyngitis, dehydration, glaucoma, intraocular pressure increased, sinusitis, intestinal obstruction ileus paralytic, dysphagia, gastrooesophageal reflux disease, glossitis, dental caries, anaphylactic reaction, skin infection and skin ulcer, dry skin. Serious undesirable effects include anaphylactic reaction, angioedema and consistent with anticholinergic effects: glaucoma, constipation, intestinal obstruction including ileus paralytic and urinary retention. An increase in anticholinergic effects may occur with increasing age. The occurrence of undesirable effects related to beta-adrenergic agonist class should be taken into consideration such as, arrhythmia, myocardial ischaemia, angina pectoris, hypotension, tremor, nervousness, muscle spasms, fatigue, malaise, hypokalaemia, hyperglycaemia and metabolic acidosis. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes and NHS price: Single pack: 1 Respimat inhaler and 1 cartridge providing 60 puffs (30 medicinal doses) £32.50 Legal category: POM MA numbers: PL 14598/0101 Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Prepared in January 2019 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 Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone). PC-UK-100779 V1 Date of preparation: April 2019