A simple switch can make a real difference


Patients stepped


Fluticasone/salmeterol MDI 250/25 µg


across to* (n=151)


fl utiform 250/10 µg (n=58)


and stepped down to**


fl utiform 125/5 µg (n=58)


Continued to benefi t from good asthma control.1,2


controlled with inhaled corticosteroids and ‘as required’ inhaled short- acting β2


-agonist and inhaled corticosteroid (ICS) in separate inhalers, or the ICS alone, should be prescribed if a patient requires doses outside the recommended dose regimens. Patients should be assessed regularly and once asthma is controlled, treatment should be reviewed and stepped down to the lowest effective dose, or an ICS alone. It is extremely important to regularly review patients as their treatment is stepped down. ICSs alone are fi rst line treatment for most patients. fl utiform is not intended for initial treatment of mild asthma. For patients with severe asthma the ICS therapy should be established before prescribing a fi xed-dose combination product. Patients on fl utiform must not use an additional LABA. An inhaled SABA should be taken for immediate relief of asthma symptoms arising between doses. The AeroChamber Plus®


patients who fi nd it diffi cult to use inhalers; re-titration should always follow the introduction of a spacer device. Patients should be advised to contact their prescriber when the fl utiform dose counter is getting near zero. Contra-indications: Hypersensitivity to any of the active substances or excipients. Precautions and warnings: fl utiform should not be used for the fi rst treatment of asthma, to treat acute asthma symptoms or for prophylaxis of exercise-induced asthma. It


spacer device is recommended in


(LABA). fl utiform 50 µg/5 µg and 125 µg/5 µg per actuation are indicated for use in adults and adolescents 12 years and above. fl utiform 250 µg/10 µg per actuation is only indicated for use in adults. Dosage and administration: For inhalation use. The patient should be shown how to use the inhaler correctly by a physician or other healthcare professional. Patients should be given the strength of fl utiform containing the appropriate fl uticasone propionate dose for their disease severity (note that fl utiform 50 µg/5 µg per actuation is not appropriate in patients with severe asthma). The appropriate strength should be taken as two inhalations, twice-daily (normally in the morning and evening) and used every day, even when asymptomatic. fl utiform should not be used in children under 12 years. Prescribers should be aware that in asthmatics, fl uticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily microgram dose. Total daily dose can be increased if asthma remains poorly controlled by administering a higher strength inhaler. Appropriate doses of the β2


-agonist (SABA), or for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2


-agonist


fumarate) pressurised inhalation suspension. Prescribing Information, United Kingdom. Please read the Summary of Product Characteristics before prescribing. Presentation: Pressurised inhalation suspension, in a pressurised metered dose inhaler (pMDI), containing fl uticasone propionate and formoterol fumarate dihydrate at strengths of 50 µg/5 µg, 125 µg/5 µg or 250 µg/10 µg per actuation. Indications: Regular treatment of asthma where the use of a combination product (inhaled corticosteroid and long-acting β2


fl utiform® -agonist) is appropriate: For patients not adequately (fl uticasone propionate and formoterol


should not be initiated during an exacerbation, during signifi cantly worsening or acutely deteriorating asthma, and should not be stopped abruptly. Patients should use their fl utiform maintenance treatment as prescribed, even when asymptomatic. If a patient experiences serious asthma-related adverse events or exacerbations, they should continue treatment but also seek medical advice. Patients should be reviewed as soon as possible if there is any indication of deteriorating asthma control. In the case of sudden and progressive deterioration, which is potentially life-threatening, an urgent medical assessment should be carried out. Use with caution in patients with: pulmonary tuberculosis; quiescent tuberculosis; fungal, viral or other infections of the airway; thyrotoxicosis; pheochromocytoma; diabetes mellitus (consider additional blood sugar controls); uncorrected hypokalaemia; predisposition to low levels of serum potassium; impaired adrenal function


drugs that can induce or potentiate a hypokalaemic effect. Particular caution is recommended in unstable or acute severe asthma and other conditions when the likelihood for hypokalemia adverse effects is increased. Monitoring of serum potassium levels is recommended during these circumstances. Formoterol may induce prolongation of the QTc interval. Caution must be observed when treating patients with existing prolongation of QTc interval. fl utiform should be discontinued immediately if there is evidence of paradoxical bronchospasm. Systemic effects with an ICS may occur, particularly at high doses for prolonged periods or when combined with potent CYP3A4 inhibitors, but are less likely than with oral corticosteroids. Use of a spacer device may also cause an increased systemic exposure. Increased exposure can be expected in patients with severe hepatic impairment. Prolonged treatment with high doses of corticosteroids may result in adrenal suppression and acute adrenal crisis, particularly in adolescents and children or potentially as a result of trauma, surgery, infection or rapid dose reduction. Patients should be advised that fl utiform contains a small amount of ethanol; however this negligible amount does not pose a risk to patients. fl utiform is not recommended in children under 12 years of age. Interactions: Caution is advised in long-term co-administration with strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfi navir, saquinavir, ketoconazole and telithromycin); co-administration should be avoided if possible. Ritonavir in particular should be avoided, unless the benefi ts outweigh the risks of systemic side-effects. Caution is advised with use of non-potassium sparing diuretics (e.g.


obstructive cardiomyopathy; idiopathic subvalvular aortic stenosis; severe hypertension; aneurysm or other severe cardiovascular disorders. There is risk of potentially serious hypokalaemia with high doses of β2


-agonists or concomitant treatment with β2 -agonists and


glucocorticosteroids, L-Dopa, L-thyroxine, oxytocin, alcohol or other adrenergic drugs. There is an increased risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Hypokalaemia may increase the risk of arrhythmias in patients being


References: 1. Kemppinen A, Gardener E, Thomas V et al. J Thorac Dis 2016; 8(Suppl 5):AB038. 2. Kemppinen A, Gardener E, Thomas V et al. J Thorac Dis 2016; 8(Suppl 5):AB039.


ACQ7: 7-item Asthma Control Questionnaire. loop or thiazide), xanthine derivatives, (monitor HPA axis function regularly); hypertrophic


treated with digitalis glycosides. Concomitant use of β-adrenergic drugs can have a potentially additive effect. Caution should be taken when using formoterol fumarate with drugs known to prolong the QTc interval, such as tricyclic antidepressants or MAOIs (and for two weeks following their discontinuation), as well as antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide and antihistamines. Concomitant use of an MAOI or a similar agent, such as furazolidone or procarbazine, may precipitate hypertensive reactions. β-blockers and formoterol fumarate may inhibit the effect of each other. β-blockers may produce severe bronchospasm in asthma patients, and they should not normally be treated with β-blockers including those that are used as eye drops to treat glaucoma. Under certain circumstances, e.g. as prophylaxis after myocardial infarction, cardioselective β blockers could be considered with caution. Pregnancy and lactation: fl utiform is not recommended during pregnancy. It should only be considered if benefi ts to the mother outweigh risks to the foetus. It is not known whether fl uticasone propionate or formoterol are excreted in breast milk; a risk to the breast feeding infant cannot be excluded. A decision should be made on whether to discontinue breastfeeding or discontinue/abstain from fl utiform. Side-effects: Potentially serious side-effects:


extrasystoles; angina pectoris; tachycardia; hypertension; dyspnoea; peripheral oedema; Cushings Syndrome; adrenal suppression; growth retardation; cataract and glaucoma; hypersensitivity reactions and QTc interval prolongation. Please consult the SPC for details of non-serious side-effects and those reported for the individual molecules. Legal category: POM. Package quantities and price: One inhaler containing 120


5 µg - £28.00. 250 µg/10 µg - £45.56. Marketing Authorisation numbers: PL 16950/0167.


Marketing Authorisation holder: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact medicalinformationuk@ napp.co.uk. Date of preparation: July 2015 Date effective: August 2015. ®FLUTIFORM is a registered trademark of Jagotec AG, and is used under licence. ®The ‘lung’ device (logo) is a registered trademark of Mundipharma AG. ®AEROCHAMBER and AEROCHAMBER PLUS are registered trademarks of Trudell Medical International. © 2012 Napp Pharmaceuticals Limited. UK/FLUT-15085


actuations. 50 µg/5 µg - £14.40. 125 µg/ PL 16950/0168.


PL16950/0169.


Adverse events should be reported. Reporting forms and information can be found at http://www.mhra.gov. uk/yellowcard. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.


behavioural changes (predominantly in children); bronchospasm;


agitation;


hyperglycaemia; vertigo;


depression; palpitations;


aggression; paradoxical ventricular


Date of preparation: November 2016 UK/FLUT-16047a


Based on a two phase, 24-week pragmatic, open-label, randomised, controlled


non-inferiority trial in 225 adult patients with asthma. Non-inferiority limit on the ACQ7 was set at 0.3.


* (mean difference [95% CI] -0.11 [-0.31,0.09]) ** (mean difference [95% CI] 0.01 [-0.20,0.22])


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