PracticeUpdate Conference Series: ERS 2018

CHOICEOFDEVICE. ‡1,2 FULL ICS DOSE RANGE. ^1–3 For Treatment in Asthma. 1,2 ‡ Symbicort for oral inhalation as Turbuhaler ® or Rapihaler. ® 1,2 ^ Low, medium and high ICS doses available. 1–3 ICS = inhaled corticosteroid.

PBS Information: Authority required (STREAMLINED). Asthma. Refer to PBS Schedule for full authority information.

BEFORE PRESCRIBING PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342 OR www.astrazeneca.com.au/PI Symbicort ® Turbuhaler ® (budesonide and formoterol (eformoterol) fumarate dihydrate*) for oral inhalation. Indications: Asthma: Treatment of asthma where use of a combination (inhaled corticosteroid and long acting β 2 -agonist) is appropriate in adults and adolescents. COPD: Symptomatic treatment of moderate to severe chronic obstructive pulmonary disease (COPD), (FEV 1 ≤50% predicted normal) in adults with frequent symptoms despite long acting bronchodilator use, and/or a history of recurrent exacerbations. Symbicort is not indicated for the initiation of bronchodilator therapy in COPD. Dosage: Asthma: There are two alternative treatment regimens for asthma: Symbicort Maintenance and Reliever Therapy (SMART TM ) or Symbicort Maintenance Therapy. Refer to Product Information for full details on dosage. Symbicort Maintenance and Reliever Therapy (SMART TM ) for Asthma: Symbicort 100/6 and 200/6: Adults and adolescents ≥ 12 years: 2 inhalations per day given as either 1 inhalation twice daily or 2 inhalations in either the morning or evening. For some patients, a maintenance dose of Symbicort 200/6 2 inhalations twice daily may be appropriate. Patients may take an additional inhalation as needed in response to symptoms, up to 6 inhalations at one time. If patients experience a three-day period of deteriorating symptoms after taking the appropriate dose, the patient should be re-assessed. A total daily dose of up to 12 inhalations can be used temporarily. Symbicort 400/12: The 400/12 strength should not be used for Symbicort Maintenance and Reliever therapy. Symbicort Maintenance Therapy for Asthma: Symbicort 100/6 and 200/6: Adults and adolescents ≥ 12 years: 1–2 inhalations twice daily. Symbicort 400/12: Adults ≥ 18 years: 1–2 inhalations twice daily. Dosage: COPD: Symbicort 200/6: 2 inhalations twice daily. Symbicort 400/12: 1 inhalation twice daily. Contraindications: Hypersensitivity to any of the ingredients. Precautions: Symbicort therapy should not be initiated to treat a severe exacerbation. Not for initiation of inhaled steroids in patients transferring from oral steroids; impaired adrenal function; infections of the respiratory system; increased susceptibility to sympathomimetic amines; severe cardiovascular conditions; hypokalaemia; diabetes; impaired renal and hepatic function; pregnancy (category B3); lactation; children <12 years. Pneumonia: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. Pneumonia has been reported following the administration of inhaled corticosteroids. Interactions: CYP3A4 inhibitors (e.g. ketoconazole); beta-receptor blockers; beta-adrenergic stimulants; sympathomimetic amines (e.g. ephedrine); MAOIs; tricyclics antidepressants; quinidine; disopyramide; procainamide; phenothiazines; antihistamines associated with QT interval prolongation e.g. terfenadine, astemizole; if hypokalaemia: xanthine derivatives, mineralocorticoids, diuretics, digoxin. Adverse effects: Common: tremor, palpitations, oropharyngeal candidiasis, headache, throat irritations, coughing, hoarseness; others, see full PI. Date of first inclusion in the ARTG: 27 May 2002 (Symbicort Turbuhaler 100/6 and 200/6); 5 May 2004 (Symbicort Turbuhaler 400/12). Date of most recent amendment: 19 December 2017. Symbicort ® Rapihaler ® (budesonide and formoterol fumarate dihydrate*) for oral inhalation. Indications: Asthma: Treatment of asthma where use of a combination (inhaled corticosteroid and long acting β 2 -agonist) is appropriate in adults and adolescents. COPD: Symptomatic treatment of moderate to severe chronic obstructive pulmonary disease (COPD), (FEV 1 ≤50% predicted normal) in adults with frequent symptoms despite long acting bronchodilator use, and/or a history of recurrent exacerbations. Symbicort is not indicated for the initiation of bronchodilator therapy in COPD. Dosage: Asthma: There are two alternative treatment regimens for asthma: Symbicort Maintenance and Reliever Therapy (SMART TM ) or Symbicort Maintenance Therapy. Refer to Product Information for full details on dosage. Symbicort Maintenance and Reliever Therapy (SMART TM ) for Asthma: Symbicort 50/3 and 100/3: Adults and adolescents ≥ 12 years: 4 inhalations per day given as either 2 inhalations twice daily or 4 inhalations in either the morning or evening. For some patients, a maintenance dose of Symbicort 100/3 4 inhalations twice daily may be appropriate. Patients may take 2 additional inhalations as needed in response to symptoms, up to 12 inhalations at one time. If patients experience a three-day period of deteriorating symptoms after taking the appropriate dose, the patient should be reassessed. A total daily dose of up to 24 inhalations can be used temporarily. Symbicort 200/6: The 200/6 strength should not be used for Symbicort Maintenance and Reliever Therapy. Symbicort Maintenance Therapy for Asthma: Symbicort 50/3 and 100/3: Adults and adolescents ≥ 12 years: 2 or 4 inhalations twice daily. Symbicort 200/6: Adults ≥ 12 years: 2 inhalations twice daily. Dosage: COPD: Symbicort 200/6: 2 inhalations twice daily. Contraindications: Hypersensitivity to any of the ingredients. Precautions: Symbicort therapy should not be initiated to treat a severe exacerbation. Not for initiation of inhaled steroids in patients transferring from oral steroids; impaired adrenal function; infections of the respiratory system; increased susceptibility to sympathomimetic amines; severe cardiovascular conditions; hypokalaemia; diabetes; impaired renal and hepatic function; pregnancy (category B3); lactation; children <12 years. Pneumonia: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. Pneumonia has been reported following the administration of inhaled corticosteroids. Interactions: CYP3A4 inhibitors (e.g. ketoconazole); beta-receptor blockers; beta-adrenergic stimulants; sympathomimetic amines (e.g. ephedrine); MAOIs; tricyclics antidepressants; quinidine; disopyramide; procainamide; phenothiazines; antihistamines associated with QT interval prolongation e.g. terfenadine, astemizole; if hypokalaemia: xanthine derivatives, mineralocorticoids, diuretics, digoxin. Adverse effects: Common: tremor, palpitations, oropharyngeal candidiasis, headache, throat irritations, coughing, hoarseness; others, see full PI. First inclusion in the ARTG: 22 February 2006 (Symbicort Rapihaler 200/6), 20 April 2011 (Symbicort Rapihaler 50/3), 26 July 2012 (Symbicort Rapihaler 100/3). Date of most recent amendment: 28 March 2017. *Please note changes to Product Information - eformoterol fumarate dihydrate is now known as formoterol fumarate dihydrate References: 1. Symbicort ® Turbuhaler ® Approved Product Information, 19 December 2017. 2. Symbicort ® Rapihaler ® Approved Product Information, 28 March 2017. 3. http://www.asthmahandbook.org.au/ management/adults. Date accessed: 27 April, 2018. Symbicort, ® Rapihaler ® and Turbuhaler ® are registered trademarks and SMART ™ is a trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries: 1800 805 342 or medinfo.australia@astrazeneca.com.au. To report an adverse event: 1800 805 342 or via https://aereporting.astrazeneca.com. Date of preparation: September 2018. 15147. AU-5018.