Nursing in Practice Autumn 2021 (issue 121) - Page 43
The only extrafine formulation ICS / LABA / LAMA combination 1,2
Designed to reach the large and small airways 1,3
Consider prescribing Trimbow for your adult patients with moderate to severe COPD not adequately treated with ICS / LABA + LAMA via multiple inhalers
Think triple ( ICS / LABA / LAMA ), think Trimbow
UK-TRI-2000248 . January 2021 .
Prescribing Information can be found below .
Trimbow is indicated for 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 β 2 ‐agonist or a combination of a long‐acting β 2 ‐agonist and a long‐acting muscarinic antagonist ( for effects on symptoms control and prevention of exacerbations see section 5.1 of the SPC ). 1
COPD : chronic obstructive pulmonary disease ; ICS : inhaled corticosteroid ; LABA : long-acting β 2 -agonist; LAMA : long-acting muscarinic antagonist ; SPC : Summary of ProductCharacteristics
References : 1 . Trimbow Summary of Product Characteristics . Chiesi Limited . 2 . MIMS Online . 2021 . Available at : www . mims . co . uk . Accessed January 2021 . 3 . Singh D . Tuberc Respir Dis . 2017 ; 80 : 317 – 324 .
Trimbow 87 / 5 / 9 Pressurised Metered Dose Inhaler ( pMDI ) Prescribing Information Please refer to the Summary of Product Characteristics ( SPC ) before prescribing . Presentation : Each Trimbow 87 / 5 / 9 pMDI delivered dose contains 87micrograms ( mcg ) of beclometasone dipropionate ( BDP ), 5mcg of formoterol fumarate dihydrate ( formoterol ) and 9mcg of glycopyrronium . This is equivalent to a metered dose of 100mcg BDP , 6mcg formoterol and 10mcg glycopyrronium . Indication : COPD : 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 beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist ( for effects on symptoms control and prevention of exacerbations see section 5.1 of the SPC ). Asthma : Maintenance treatment of asthma , in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid , and who experienced one or more asthma exacerbations in the previous year . Dosage and administration : For inhalation in adult patients ( ≥18 years ). COPD & Asthma: 2 inhalations twice daily . Maximum dose 2 inhalations twice daily . Can be used with the AeroChamber Plus ® spacer device . Patients should be advised to take Trimbow every day even when asymptomatic . If symptoms arise in the period between doses , an inhaled , short-acting beta2-agonist should be used for immediate relief . When choosing the starting dose strength of Trimbow in asthma patients , the patients ’ disease severity , their previous asthma therapy including the inhaled corticosteroid ( ICS ) dose as well as the patients ’ current control of asthma symptoms and risk of future exacerbation should be considered . The aerosol particles of Trimbow are characterised by an extrafine particle size distribution . For BDP this results in a more potent effect than formulations of BDP with a non-extrafine particle size distribution ( 100mcg of BDP extrafine in Trimbow are equivalent to 250mcg of BDP in a non-extrafine formulation ). Contraindications : Hypersensitivity to the active substances or to any of the excipients . Warnings and precautions : Not for acute use in treatment of acute episodes of bronchospasm or to treat an acute disease exacerbation . Discontinue immediately if hypersensitivity or paradoxical bronchospasm occur . Deterioration of disease : Trimbow should not be stopped abruptly . Cardiovascular effects : Due to the presence of a long-acting beta2-agonist and a long-acting muscarinic antagonist , use with caution in patients with cardiac arrhythmias , idiopathic subvalvular aortic stenosis , hypertrophic obstructive cardiomyopathy , severe heart disease , occlusive vascular diseases , arterial hypertension and aneurysm . Caution should also be used when treating patients with known or suspected prolongation of the QTc interval ( QTc > 450 milliseconds for males , or > 470 milliseconds for females ) either congenital or induced by medicinal products . Limited data in asthmatic patients with cardiovascular co-morbidities or risk-factors suggest that these patients are also at higher risk of adverse reactions like local fungal infections or dysphonia . Trimbow should not be administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias . Caution in patients with thyrotoxicosis , diabetes mellitus , pheochromocytoma and untreated hypokalaemia . Increase in pneumonia and pneumonia hospitalisation in COPD patients receiving ICS observed . Clinical features of pneumonia may overlap with symptoms of COPD exacerbations . Systemic effects of ICS may occur , particularly at high doses for long periods , but are less likely than with oral steroids . The daily dose of Trimbow 87 / 5 / 9 corresponds to a medium dose of ICS . Possible systemic effects include Cushingʼs syndrome , Cushingoid features , adrenal suppression , growth retardation , decrease in bone mineral density and , more rarely , a range of psychological or behavioural effects including psychomotor hyperactivity , sleep disorders , anxiety , depression and aggression . Patients on Trimbow should be reviewed regularly and the dose of ICS is reduced to the lowest dose at which effective control of asthma is maintained . Use with caution in patients with pulmonary tuberculosis or fungal / viral airway infections . Potentially serious hypokalaemia may result from beta2-agonist therapy ( particular caution with severe disease ). Formoterol may cause a rise in blood glucose levels . Glycopyrronium should be used with caution in patients with narrow-angle glaucoma , prostatic hyperplasia or urinary retention . Use in patients with severe hepatic or renal impairment should only be considered if benefit outweighs the risk . Consider referral of patients reporting blurred vision or visual disturbances to an ophthalmologist as causes may include cataract , glaucoma or rare diseases such as central serous chorioretinopathy . To reduce risk of oropharyngeal candida infection , patients should be advised to rinse mouth or gargle with water without swallowing or brush teeth after inhaling prescribed dose . Interactions : Since glycopyrronium is eliminated via renal route , interactions could occur with medicinal products affecting renal excretion mechanisms e . g . with cimetidine ( an inhibitor of OCT2 and MATE1 transporters in the kidney ) co-administration , glycopyrronium showed a slight decrease in renal clearance ( 20 %) and a limited increase in total systemic exposure ( 16 %). Possibility of systemic effects with concomitant use of strong CYP3A inhibitors ( e . g . ritonavir , cobicistat ) cannot be excluded and therefore caution and appropriate monitoring is advised . Related to formoterol : Non-cardioselective beta-blockers ( including eye drops ) should be avoided as reduces effect of formoterol . Concomitant administration of other beta-adrenergic drugs may have potentially additive effects . Concomitant treatment with quinidine , disopyramide , procainamide , antihistamines , monoamine oxidase inhibitors ( MAOIs ), tricyclic antidepressants and phenothiazines can prolong the QTc interval and increase the risk of ventricular arrhythmias . L-dopa , L-thyroxine , oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics . Hypertensive reactions may occur following co-administration with MAOIs including drugs with similar properties ( e . g . furazolidone , procarbazine ). Risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons . Concomitant treatment with xanthine derivatives , steroids or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists . Hypokalaemia may increase the likelihood of arrhythmias in patients receiving digitalis glycosides . Related to glycopyrronium : Co-administration with other anticholinergic-containing medicinal products is not recommended . Excipients : Presence of ethanol may cause theoretical potential interaction in sensitive patients taking metronidazole or disulfiram . Fertility , pregnancy and lactation : No studies have been performed in regards to safety in human fertility , but animal studies show impaired fertility . Should only be used during pregnancy if the expected benefits outweigh the potential risks . Children born to mothers receiving substantial doses should be observed for adrenal suppression . Glucocorticoids and metabolites are excreted in human milk . It is unknown whether formoterol or glycopyrronium ( including their metabolites ) pass into human breast-milk but they have been detected in the milk of lactating animals . Anticholinergics like glycopyrronium could suppress lactation . A decision must be made whether to discontinue breastfeeding or to discontinue / abstain from therapy . Effects on driving and operating machinery : None or negligible . Side effects : Common : pneumonia ( in COPD patients ), pharyngitis , oral candidiasis , urinary tract infection , nasopharyngitis , headache , dysphonia . Uncommon : influenza , oral fungal infection , oropharyngeal candidiasis , oesophageal candidiasis , fungal oropharyngitis , sinusitis , rhinitis , gastroenteritis , vulvovaginal candidiasis , granulocytopenia , dermatitis allergic , hypokalaemia , hyperglycaemia , restlessness , tremor , dizziness , dysgeusia , hypoaesthesia , otosalpingitis , atrial fibrillation , electrocardiogram QT prolonged , tachycardia , tachyarrhythmia , palpitations , hyperaemia , flushing , hypertension , asthmatic crisis , cough , productive cough , throat irritation , epistaxis , pharyngeal erythema , diarrhoea , dry mouth , dysphagia , nausea , dyspepsia , burning sensation of the lips , dental caries , aphthous stomatitis , rash , urticaria , pruritus , hyperhidrosis , muscle spasms , myalgia , pain in extremity , musculoskeletal chest pain , fatigue , C-reactive protein increased , platelet count increased , free fatty acids increased , blood insulin increased , blood ketone body increased , cortisol decreased . Rare : Lower respiratory tract infection ( fungal ), hypersensitivity reactions , including erythema , lips , face , eye and pharyngeal oedema , decreased appetite , insomnia , hypersomnia , angina pectoris ( stable and unstable ), extrasystoles ( ventricular and supraventricular ), nodal rhythm , sinus bradycardia , blood extravasation , paradoxical bronchospasm , exacerbation of asthma , oropharyngeal pain , pharyngeal inflammation , dry throat , angioedema , dysuria , urinary retention , nephritis , asthenia , blood pressure increased , blood pressure decreased . Very rare : thrombocytopenia , adrenal suppression , glaucoma , cataract , dyspnoea , growth retardation , peripheral oedema , bone density decreased . Frequency not known : psychomotor hyperactivity , sleep disorders , anxiety , depression , aggression , behavioural changes , blurred vision . ( Refer to SPC for full list of side effects ). Legal category : POM . Price and Pack : £ 44.50 1x120 actuations . Marketing authorisation ( MA ) No ( s ): PLGB 08829 / 0193 ( GB ), EU / 1 / 17 / 1208 / 002 ( UKNI ). GB MA holder / UKNI Distributor : Chiesi Limited , 333 Styal Road , Manchester , M22 5LG , United Kingdom . Date of Preparation : Jan 2021 .
Adverse events should be reported . Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store . Adverse events should also be reported to Chiesi Limited on 0800 0092329 ( UK ) or PV.UK@Chiesi.com .