COPD Management and Treatment Options Including the Role of Onbrez Breezhaler and Seebri Breezhaler Speaker: Dr Andrew Bradbeer Respiratory & Sleep Physician Registration Form Title First name Last name Address Details Date: Thursday 9th October, 2014 Venue: Café Jas Address: 37 Roberts Place Horsham, VIC Agenda Suburb State Postcode Phone no 7:30pm Arrivals and Registration 7:45pm Welcome and Introductions Fax no 8:00pm Presentation and Dinner Mobile No COPD Management and Treatment Options Including the Role of Onbrez Breezhaler and Seebri Breezhaler Email 9:00pm Questions and Answers 9:30pm Close and End of Meeting Dietary Requirements Tick this box to receive an SMS reminder to this event Collection Statement: By providing your personal information to Novartis Pharmaceuticals Australia Pty Ltd or its related bodies corporate (Novartis), you consent to Novartis collecting, storing and using your personal information in accordance with the Novartis Privacy Policy. In particular, you consent to Novartis using your personal information to communicate with you about Novartis products and/or to support your use of those products. You also consent to Novartis using your personal information to (where applicable) invite you to, or arrange your participation in, activities managed by (or on behalf of) Novartis. You are not obliged to provide personal information. However, if you do not provide information you may not, for example, be able to participate fully in activities managed by us. You have the right to access, update or correct your personal information and/or decline to receive communications from Novartis. To find out how, please refer to our: Privacy Policy (http://www.novartis.com.au/privacy-policy/privacy-policy.shtml) or contact our Privacy Officer at Novartis Australia, PO Box 101, (54 Waterloo Road) North Ryde NSW 1670. Ph: 02 9805 3555 Email: [email protected]. Disclaimer: Other than information directly presented by Novartis Pharmaceuticals Australia Pty Limited (Novartis), Novartis gives no warranty or assurance in relation to any information provided, or views expressed during the meeting, and to the maximum extent permitted by law, disclaims all liability for matters arising from such views or information. SE0502 Note: In line with the Medicines Australia Code of Conduct, hospitality, travel or other expenses of any guest, family, or travelling companion will not be paid for or subsidised by Novartis. Fax to: 02 8874 2353 to register by Thursday 2nd October, 2014 For more information contact your local Novartis representative Satish Shettigara Pathik Shah 0412 553 676 0428 065 257 ♦ Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow limitation in patients with COPD. ♦ Onbrez Breezhaler should not be used in asthma due to the absence of long-term outcome data in asthma with Onbrez Breezhaler. Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.* A differential diagnosis should be made to exclude asthma or mixed airways disease before initiating Onbrez.♦ The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler. The dose should only be increased on medical advice. ♦ Onbrez Breezhaler should not be used in combination with other long-acting β2-agonists such as eformoterol and salmeterol or their combination products. PBS Information: Restricted Benefit. Chronic Obstructive Pulmonary Disease. See approved Product Information before prescribing. Approved Product Information available on request. ONBREZ BREEZHALER (indacaterol maleate) Indication: Long-term maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease (COPD). Dosage and administration: Recommended dose: 150µg once daily, using the Breezhaler inhaler. The maximum dose is 300 µg once-daily. Contraindications: Hypersensitivity to any ingredients, galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Precautions: Asthma: Should not be used in asthma. Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma* ♦ Hypersensitivity: If hypersensitivity reaction occurs, treatment should be discontinued immediately and alternative therapy instituted ♦ Corticosteroids: COPD patients being treated with long-term inhaled glucocorticoids therapy should continue this therapy when initiating indacaterol ♦ If paradoxical bronchospasm occurs, treatment should be discontinued immediately. ♦ In case of deterioration of COPD whilst on treatment, a re-evaluation of the patient and COPD treatment regimen should be undertaken. The patient’s COPD management plan should make this clear. ♦ Should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension); in patients with convulsive disorders or thyrotoxicosis; in patients who are unusually responsive to β2-adrenergic agonists; ♦ Cardiovascular effects: like other β 2-adrenergic agonists, indacaterol can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms, ECG changes. In case such effects occur, the drug may need to be discontinued. ♦ β 2-adrenergic agonists may produce significant hypokalemia. Hypokalemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias ♦ Clinically notable changes in blood glucose and/or serum potassium were infrequent ♦ Should not be used in conjunction with other longacting β2-adrenergic agonists or medications containing long-acting β2-adrenergic agonists. ♦ Pregnancy (Category B3): Should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. ♦ Use in lactation: Should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Interactions: Caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QT interval ♦ Concomitant administration of other sympathomimetic agents may potentiate the undesirable effects ♦ Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate the possible hypokalaemic effect of β 2adrenergic agonists ♦ Should not be given together with β2 -adrenergic blockers (including eye drops) unless there are compelling reasons for their use. Side effects: Common (1 to 10%): nasopharyngitis, upper respiratory tract infection, sinusitis, cough, oropharyngeal pain, rhinorrhoea, headache, paresthesia, muscle spasm, myalgia, peripheral oedema, ischaemic heart disease, musculoskeletal pain, chest pain, diabetes mellitus and hyperglycaemia, dry mouth ♦ Uncommon (0.1 to 1%): atrial fibrillation, chest discomfort, vertigo, paresthesia. (obb060214m.doc) For most up to date Product Information go to http://www.novartis.com.au/products_healthcare.html *Please note changes in Product Information PBS Information: Restricted Benefit. Chronic Obstructive Pulmonary Disease (COPD). See approved Product Information before prescribing. Approved Product Information available on request. SEEBRI BREEZHALER (glycopyrronium bromide) Indication: Once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). Dosage and administration: Recommended dose: 50μg once daily using only the Breezhaler inhaler. Do not swallow the capsules.* Contraindications: Hypersensitivity to any ingredients, galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Precautions: Acute use: should not be used as rescue therapy ♦ Hypersensitivity: if hypersensitivity reaction occurs, SEEBRI BREEZHALER should be discontinued immediately and alternative therapy instituted.* ♦ Paradoxical bronchospasm: as with other inhalation therapy, administration may result in paradoxical bronchospasm that may be lifethreatening. If paradoxical bronchospasm occurs, SEEBRI BREEZHALER should be discontinued immediately and alternative therapy instituted ♦ Anticholinergic effect: use with caution in patients with narrow-angle glaucoma and urinary retention. Discontinue when signs and symptoms of acute narrow-angle glaucoma occur. Monitor for signs and symptoms of hyperplasia or bladder-neck obstruction.* ♦ Renal impairment: to be used only if expected benefit outweighs potential risk in patients with severe renal impairment including end-stage renal disease requiring dialysis. ♦ Pregnancy (Category B3): Should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. ♦ Use in lactation: Should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Interactions: Co-administration with other inhaled anticholinergic-containing drugs has not been studied and is therefore not recommended. Side effects: Common (1 to 10%): dry mouth, insomnia, gastroenteritis ♦ Uncommon (0.1 to 1%): dyspepsia, dental caries, pain in extremity, musculoskeletal chest pain, rash, fatigue, asthenia, sinus congestion, productive cough, throat irritation, epistaxis, rhinitis, cystitis, hyperglycaemia, urinary retention, dysuria, atrial fibrillation, palpitations, hypoaesthesia. ♦ Not known: angioedema.* ♦ Other ADRs: nasopharyngitis, vomiting, musculoskeletal pain, neck pain, diabetes mellitus ♦ Elderly patients only: headache, urinary tract infection. (see260614m.doc) For medical enquiries please contact 1800 671 203 (phone) or [email protected] (email) Novartis Pharmaceuticals Pty Limited. 54 Waterloo Road, North Ryde NSW 2113. Ph (02) 9805 3555. ® Registered Trademark. *Please note changes in Product Information For the most up to date Product Information go to http://www.novartis.com.au/products_healthcare.html Note: Novartis will disclose the cost of all hospitality provided for this meeting in a report that is published online, the names of attendees will not be included. Attendees are responsible for obtaining approval to receive and/or disclose hospitality as required by their employer or professional association. Novartis is committed to patient safety. In accordance with regulatory obligations, Novartis has a systematic process in place to collect, store and process reports of adverse events experienced by patients taking a Novartis product, when identified by a Novartis representative (or by a third party acting on behalf of Novartis). All information forwarded to the Novartis drug safety department is treated in accordance with local privacy laws and may be captured and processed in countries outside of the national territory, and shared with health authorities or other Pharmaceutical companies with whom Novartis has a license agreement, for the purpose of meeting the regulatory requirements for reporting safety information on Novartis products. Novartis drug safety department may contact the patient’s healthcare professional in order to collect further information on the adverse event. Confidential. Creation Date: 02.09.2014. Private Document. SEE0502