NEW INDICATION 1
ULTIBRO ® BREEZHALER ® 110 / 50 is the only proven LABA / LAMA to reduce exacerbation risk vs both Spiriva ®†‡ and Seretide ® 50 / 500^ * 2, 3
†
14 % ^17 %
REDUCTION REDUCTION
Rate of all exacerbations over 64 weeks vs open-label Spiriva ® Handihaler ®( tiotropium) 18 µ g ‡ [ 95 % CI: 0.78 – 0.94 ] p = 0.0017 2
Statistical significance was not met for the key secondary endpoint of a reduction in moderate-severe exacerbations vs open-label Spiriva ® Handihaler ®‡ 2
Rate of moderate-severe exacerbations in exacerbating patients over 52 weeks vs Seretide ®( salmeterol / fluticasone) 50 / 500 µ g * [ 95 % CI: 0.75 – 0.91 ] p < 0.001 3
Adapted from Wedzicha JA, et al. 2013. 2 † Primary endpoint: rate of moderate or severe COPD exacerbations over 64 weeks for ULTIBRO ® BREEZHALER ® 110 / 50 µ g vs SEEBRI ® BREEZHALER ® 50 µ g = 12 % RRR, p = 0.038.
Adapted from Wedzicha JA, et al. 2016. 3 ^ Primary endpoint: annual rate of all COPD exacerbations in per-protocol population. ULTIBRO ®
BREEZHALER ® 110 / 50 µ g = 3.59 vs salmeterol / fluticasone 50 / 500 µ g = 4.03; 11 % RRR, p = 0.003.
‡Spiriva ® Handihaler ®( tiotropium) is indicated for patients with COPD. 4 * Seretide ®( salmeterol / fluticasone) 50 / 500 µ g is indicated for patients with severe COPD( FEV 1
< 50 % predicted) and previous exacerbations. 5
glucose( 4.9 %) than on placebo( 2.7 %). There is no data in patients with uncontrolled diabetes mellitus. Pregnancy: Category B3. Lactation: Should only be considered if expected benefit to the woman is greater than any possible risk to the infant. Indacaterol may inhibit labor due to a relaxant effect on uterine smooth muscle. INTERACTIONS: Should not be given together with ß-blockers( including eye drops) unless there are compelling reasons. Caution in patients being treated with MAO inhibitors, tricyclic antidepressants, or drugs known to prolong QT-interval, which may increase the risk of ventricular arrhythmia. Co-administration of other sympathomimetics may potentiate the undesirable effects. Co-treatment with methylxanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate the hypokalemic effect of ß 2
-agonists. Co-administration with other inhaled anticholinergics is not recommended. No clinically relevant drug interaction expected when co-administered with cimetidine or other organic cation transport inhibitors. ADVERSE EFFECTS: Uncommon but potentially serious: glaucoma, ischemic heart disease, atrial fibrillation, paradoxical bronchospasm. Very common: upper respiratory tract infection. Common: hyperglycemia and diabetes mellitus, hypersensitivity, nasopharyngitis, urinary tract infection, sinusitis, dizziness, headache, cough, oropharyngeal pain, throat irritation, dyspepsia, dental caries, pyrexia, chest pain, bladder obstruction. Others, see full PI.( ulb070218m. doc)
* Please note changes in Product Information in italics. For the most up to date Product Information go to http:// www. novartis. com. au / products _ healthcare. html.
References: 1. ULTIBRO ® BREEZHALER ® 110 / 50 Approved Product Information. February 2018. 2. Wedzicha JA et al. Lancet Resp Med 2013; 1: 199 – 209. 3. Wedzicha JA et al. N Engl J Med, 2016; 374: 2222 – 34. 4. Spiriva ® Handihaler ® Approved Product Information, 13 September 2016. 5. Seretide Approved Product Information, 14 September 2016.
Spiriva ® Handihaler ® is a registered trademark of Boehringer Ingelheim Pty Limited. Seretide is a registered trademark of the GlaxoSmithKline group of companies. Novartis Pharmaceuticals Pty Limited. 54 Waterloo Road, Macquarie Park NSW 2113. Ph( 02) 9805 3555. For medical enquiries please contact 1800 671 203( phone) or medinfo. phauno @ novartis. com( email).
®
Registered Trademark. AU-4738. NOV3613. Prepared February 2018.