Practice Update - ESC Congress 2017

Nebilet ® (nebivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. Stable chronic heart failure (CHF) as an adjunct to standard therapies in patients 70 years or older. CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipients; liver insufficiency or liver function impairment; acute heart failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic therapy; sick sinus syndrome, including sino-atrial block; second and third degree heart block (without a pacemaker); history of bronchospasm (e.g. including COPD) and/or asthma; untreated phaeochromocytoma; metabolic acidosis; bradycardia (HR < 60 bpm prior to starting therapy); hypotension (systolic BP < 100 mmHg); severe peripheral circulatory disturbances. PRECAUTIONS: Avoid abrupt cessation unless clearly indicated – reduce dosage gradually over 1-2 wks; refer to full PI. If it must be withdrawn abruptly, close observation is required. Anaesthesia; untreated congestive heart failure, unless stabilised; bradycardia; peripheral circulatory disorders (e.g. Raynaud’s disease, intermittent claudication); first degree heart block; Prinzmetal’s or variant angina; lipid and carbohydrate metabolism – does not affect glucose levels in diabetic patients, but may mask symptomsofhypoglycaemia.Hyperthyroidism;COPD/asthma;phaeochromocytoma; various skin rashes; conjunctival xerosis; oculomucocutaneous syndrome; psoriasis; increased sensitivity to allergens and severity of anaphylactic reactions; galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption; driving vehicles or operating machines. Pregnancy (Cat C). Lactation. Children and adolescents. Renal and hepatic insufficiency – see Dosage and Administration. INTERACTIONS: Combination not recommended: Class I antiarrhythmics; calcium channel antagonists (verapamil/dilitiazem); centrally-acting antihypertensives; other beta-blockers (incl. eye drops). Combination to be used with caution: Class III antiarrhythmic drugs; anaesthetics (volatile); insulin and other oral diabetic medicines; calcium antagonists (dihydropyridine type); catecholamine depleting agents; baclofen; amifostine; for other combinations requiring careful consideration, see full PI. ADVERSE EFFECTS: Headache, dizziness, tiredness, fatigue, paraesthesia, constipation, nausea, diarrhoea, cardiac failure aggravated, bradycardia, hypotension, dyspnoea, oedema, slowed AV conduction/AV-block, bronchospasm. Post-marketing reports of hypersensitivity, angioneurotic oedema, abnormal hepatic function, acute pulmonary oedema, acute renal failure, myocardial infarction, others see full PI. DOSAGE AND ADMINISTRATION: Once daily dosing, can be given with or without meals,consistent approach is recommended. Hypertension: 5 mg daily. Renal insufficiency: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 65 years: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 75 years: caution must be exercised and these patients monitored closely. Chronic Heart Failure: The initial up titration should be done gradually at 1-2 wk intervals based on patient tolerability starting at 1.25 mg once daily, increased to 2.5 mg, then to 5 mg and then to 10 mg once daily. Initiation of therapy and every dose increase should be done under close supervision for at least 2 h. No dose adjustment is required in patients with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 µ mol/L) is not recommended. Date prepared 17 December 2015. References: 1. Nebilet Approved Product Information, 14 December 2015. 2. Flather MD et al. Eur Heart J 2005; 26: 215–25. Please review full Product Information before prescribing. The Product Information can be accessed at www.menarini.com.au/pi Nebilet ® (nebivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. Stable chronic heart failure (CHF) as an adjunct to standard therapies in patients 70 years or older. CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipients; liver insufficiency or liver function impairment; acute heart failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic therapy; sick sinus syndrome, including sino-atrial block; second and third degree heart block (without a pacemaker); history of bronchospasm (e.g. including COPD) and/or asthma; untreated phaeochromocytoma; metabolic acidosis; bradycardia (HR < 60 bpm prior to starting therapy); hypotension (systolic BP < 100 mmHg); severe peripheral circulatory disturbances. PRECAUTIONS: Avoid abrupt cessation unless clearly indicated – reduce dosage gradually over 1-2 wks; refer to full PI. If it must be withdrawn abruptly, close observation is required. Anaesthesia; untreated congestive heart failure, unless stabilised; bradycardia; peripheral circulatory disorders (e.g. Raynaud’s disease, intermittent claudication); first degree heart block; Prinzmetal’s or variant angina; lipid and carbohydrate metabolism – does not affect glucose levels in diabetic patients, but may mask symptomsofhypoglycaemia.Hyperthyroidism;COPD/asthma;phaeochromocytoma; various skin rashes; conjunctival xerosis; oculomucocutaneous syndrome; psoriasis; increased sensitivity to allergens and severity of anaphylactic reactions; galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption; driving vehicles or operating machines. Pregnancy (Cat C). Lactation. Children and adolescents. Renal and hepatic insufficiency – see Dosage and Administration. INTERACTIONS: Combination not recommended: Class I antiarrhythmics; calcium channel antagonists (verapamil/dilitiazem); centrally-acting antihypertensives; other beta-blockers (incl. eye drops). Combination to be used with caution: Class III antiarrhythmic drugs; anaesthetics (volatile); insulin and other oral diabetic medicines; calcium antagonists (dihydropyridine type); catecholamine depleting agents; baclofen; amifostine; for other combinations requiring careful consideration, see full PI. ADVERSE EFFECTS: Headache, dizziness, tiredness, fatigue, paraesthesia, constipation, nausea, diarrhoea, cardiac failure aggravated, bradycardia, hypotension, dyspnoea, oedema, slowed AV conduction/AV-block, bronchospasm. Post-marketing reports of hypersensitivity, angioneurotic oedema, abnormal hepatic function, acute pulmonary oedema, acute renal failure, myocardial infarction, others see full PI. DOSAGE AND ADMINISTRATION: Once daily dosing, can be given with or without meals,consistent approach is recommended. Hypertension: 5 mg daily. Renal insufficiency: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 65 years: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 75 years: caution must be exercised and these patients monitored closely. Chronic Heart Failure: The initial up titration should be done gradually at 1-2 wk intervals based on patient tolerability starting at 1.25 mg once daily, increased to 2.5 mg, then to 5 mg and then to 10 mg once daily. Initiation of therapy and every dose increase should be done under close supervision for at least 2 h. No dose adjustment is required in patients with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 µ mol/L) is not recommended. Date prepared 17 December 2015. References: 1. Nebilet Approved Product Information, 14 December 2015. 2. Flather MD et al. Eur Heart J 2005; 26: 215–25. PBS Information: R st icted e efit. Moderate to severe heart failure. Refer to PBS Schedule for full restricted benefit information. Please review full Product Information before prescribing. The Product Information can be acc ssed at www.menarini.com.au/pi Nebilet ® (n bivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. Stable chronic heart failure (CHF) as an adjunct to standard therapies in patients 70 years or older. CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipients; liver insufficiency or liver function impairment; acut heart failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotr pic herapy; s k sinus syndrome, inclu i g sino-atri l block; s cond a d third degree heart bl ck (without a pacemaker); history of bronch spasm ( .g. including COPD) and/or asthma; ntreated pha ochromocytoma; metabolic acidosis; br dycar ia (HR < 60 bpm prior to starting therapy); hypotension (systolic BP < 100 mmHg); severe peripheral circulatory disturbances. PRECAUTIONS: Avoid abrupt cessation unless clearly indicated – reduce dosage gradually over 1-2 wks; refer to full PI. If it must be withdrawn abruptly, close observation is required. Anaesthesia; u treated congestive heart failure, unless stabilised; bradycardia; p i h ral circulatory diso de s (e.g Raynaud’s disease, intermitt nt claudication); first degree heart block; Prinzmetal’s or variant angina; lipid and carbohydrate metabolism – does not affect glucose levels in di betic pati nts, but may mask symptomsofhypoglycaemia.Hyperthyroidism;COPD/asthma;phaeochromocytoma; various skin rashes; conjunctival xerosis; oculomucocutaneous syndrome; psoriasis; increased sensitivity to allergens and severity of anaphylactic reactions; galactose intoleran e, Lapp-lactase deficiency or glucose-galactose malabsorption; driving vehicles or operating machines. Pregnancy (Cat C). Lactation. Children and adolescents. Renal and hepatic insufficiency – see Dosage and Administration. INTERACTIONS: Combination not recommended: Class I antiarrhythmics; calcium channel antagonists (verapamil/dilitiazem); centrally-acting antihypertensives; other beta-blockers (incl. eye drop ). Combi ation to be used with caution: Class III antiarrhythmic drugs; anaesthetics (volatile); insulin and other oral diabetic medicines; calcium antagonists (dihydropyridine type); catecholamine depleting agents; baclofen; amifostine; for other combinations requiring careful consideration, see full PI. ADVERSE EFFECTS: Headache, dizziness, tiredness, fatigue, paraesthesia, constipation, nausea, diarrhoea, cardiac failure aggravated, bradycardia, hypotension, dyspnoea, oedema, slowed AV conduction/AV-block, bronchospasm. Post-marketing reports of hypersensitivity, angioneurotic oedema, abnormal hepatic functio , cut pulmonary oedema, acute renal failure, myocardial infarction, others see full PI. DOSAGE AND ADMINISTRATION: Once d ily dosing, can be given with or without meals, consistent pproach is recommended. Hypertension: 5 mg daily. Renal insufficiency: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 65 years: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 75 years: caution must be exercised and these p tients monitored closely. Chronic Heart Failure: The initial up titrat should be d ne gradually at 1-2 wk in ervals ased on patient tolerability starting at 1.25 mg once daily, increased to 2.5 mg, then to 5 mg and then to 10 mg once daily. Initiation of therapy and every dose increase should be done under close supervision for at least 2 h. No dose adjustment is required in patients with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 µ mol/L) is not recommended. Date prepared 17 December 2015. References: 1. Nebilet Approved Product Inform tion, 14 Dec mber 2015. 2. Flather MD et al. Eur Heart J 2005; 26: 215–25. Please revi w full Product Information b fore presc ibing. The Product Information can be accessed at www.menarini.com.au/pi A. Me arini Australia Pty Ltd. ABN 62 116 935 758, Level 8, 67 Albert Avenue, Chatswoo NSW 2067 Medical Information 1800 644 542 NEB-AU-0506 April 2016 • ALMIN.1.2 Nebilet ® (n bivolol hydrochlo ide) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. Stable chronic heart failure (CHF) as an djunct o standard therapies n pat ents 70 years or ol . CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipi nts; liver insufficiency o liver function impair ent; acute heart failure; ca iogenic shock or episodes f heart failur decompensatio requiring IV inotropic therapy; sick sinus yndrome, includ g sino-atrial block; second and third deg ee heart block (without a pacem k r); history of b onchospasm (e.g. includ g COPD) and/or asthm ; untreated phaeoc romocytoma; metabolic acidosis; bradycar ia (HR < 60 bpm prior to starting therapy); hypotensi n ( ystolic BP < 100 mmHg); severe peripheral circu atory disturbances. PRECAUTIONS: Avoid abrupt cessation unless c arly indicate – r uce dosage gr dually over 1-2 wks; refer to full PI. If it mus be withdrawn abruptly, close ob rvation is required. Anaesthesia; untreated congestive heart failure, unl ss stabili ed; bradycar ia; peripheral circu atory disorders (e.g. Raynaud’s disease, intermit nt claudi tion); first degree h art block; Prinzmetal’s or variant angina; lipid and c rbohydr te metabolism – does n t affect glu ose level in diabetic pa ents, bu may ask sympto sofhyp gl caemia.Hyperth roidism;COPD/asthm ;phaeoc romocytoma; various skin rashes; conjunctival xerosis; culomuc cutaneous syndrome; psoriasis; ncreased sensitivity to allergens and everity of anaphyl ctic reactions; galactose intol ranc , Lapp-lactase deficiency or glucose-galactose malabsorption; driving vehicles or operating machines. Pregnancy (Cat C). Lactation. Children and adolescent . Renal and hepatic insufficiency – see Dosage and Administration. INTERACTIONS: Combination not rec mmended: Class I ntiarrhythmics; calcium channel a tagonists (verapamil/dilitiazem); centrally-acting antihypertensives; other beta- lockers (incl. eye drops). Combination to be used with cau ion: Class III antiarrhythmic drugs; anaesthetics (volatile); insulin and other oral diabetic medicin s; calcium antagonists (dihydrop ridine type); catecholamine depleting agents; baclofen; amifostine; for other combinations requiring careful considerat on, see full PI. ADVERSE FFECTS: Headache, dizziness, tiredness, fatigue, paraesthesia, constipation, nausea, di rrhoe , cardia f ilure aggravated, bradycar ia, hypotensi n, dyspnoea, oedema, slowed AV condu tion/AV-block, bronchosp sm. Post-marketing reports f hypersensitivity, angioneurotic dema, abnormal hepatic fun tion, acute p lmonary oedema, acute renal failure, myocardial infarction, o hers se full PI. DOSAGE AND ADMINISTRATION: Once daily dosing, ca be given with or without meals,con iste t appro ch is recommended. Hypertension: 5 mg daily. Renal insufficiency: re ommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 65 years: r commended starting dose is 2.5 mg daily, c n be incr ased to 5 mg if needed. Patients > 75 years: c ution must be exercised and these patients monitored closely. Chronic Heart Failure: The initial up titration should be don gradually at 1-2 wk intervals based on patient tol rability starting t 1.25 mg once daily, increased to 2.5 mg, then to 5 mg and the to 10 mg once daily. Init ation of therapy and every dose incr ase should be don und r close supervision for at least 2 h. No dose adjustment is required in pat ents with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 µ mol/L) is no rec mmended. Date prepared 17 December 2015. Referenc s: 1. Nebilet Approved Product Information, 14 December 2015. 2. Flather MD et al. Eur Heart J 2005; 26: 215– 5. PBS Information: Rest icted b nefit. Moderat to sev r heart f ilu e. Refer o PBS Schedul for full restricted b nefit in ormation. Please review full Product Information b fore p scribing. The Pro uct Information can be accessed at ww .menarini.com.au/pi PBS Information: Restricted benefit. Moderate to severe heart failure. Refer to PBS Schedule for full restricted benefit information. PBS Information: Restricted benefit. Moderate to severe heart failure. Refer to PBS Schedule for full restricted benefit information. A. Menarini Australia Pty Ltd. ABN 62 116 935 758, Level 8, 67 Albert Avenue, Chatswood NSW 2067 Medical Information 1800 644 542 NEB-AU-0506 April 2016 • ALMIN.1.2

nebivolol hydrochloride

NEBILET: Age proven in elderly ( ≥ 70 years) CHF patients 1,2 *vs placebo P= 0.039; patients ≥ 70 years regardless of age, gender or left ventricular ejection fraction NEBILET: Age proven in elderly ( ≥ 70 years) CHF patients 1,2 NEBILET reduced the risk of all cause mortality or cardiovascular hospital s tion i a broad range of eld rly CHF patients *1,2 *vs placebo P= 0.039; patien s ≥ 70 years regardless of age, nd r or left ventricular ejection fraction Elderly ( ≥ 70 years) CHF patients deserve an age proven blocker 1,2 NEBILET reduced the risk of all cause mortality or cardiovascular hospitalisation in a broad range of elderly CHF patients *1,2 *vs placebo P= 0.039; patients ≥ 70 years regardless of age, gender or left ventricular ejection fraction Elderly ( ≥ 70 y ars) CHF patients deserve an age proven blocker 1,2 NEBILET reduced the risk of all cause mortality or cardiovascular hospitalisation in a broad range of elderly CHF patients *1,2 Elderly ( ≥ 70 years) CHF patients deserve an g prov n blocker 1,2 NEBILET reduced the risk of all cause mortality or cardiovascular hospitalisation in a broad range of elderly CHF patients *1,2 *vs placebo P= 0.039; patients ≥ 70 years regardless of age, gender or left ventricular ejection fracti n Elderly ( ≥ 70 years) CHF patients d serve an age proven blocke 1,2

NEBILET: Age proven in eld rly ( ≥ 70 years) CHF patients 1,2

NEBILET: Age proven in elderly ( ≥ 70 years) CHF patients 1,2

CHF= Chronic Heart Failure

CHF= Chronic Heart Failure

A. Menarini Australia P y Ltd. ABN 62 116 935 758, Level 8, 67 Albert Avenue, Chatswood NSW 2067 Medical Informati n 1800 644 542 NEB-AU-0506 April 2016 • ALMIN.1.2

A. Menarini Australia Pty Ltd. ABN 62 116 935 758, Level 8, 67 Albert Avenue, Chatswood NSW 2067 Medical Information 1800 644 542 NEB-AU-0506 April 2016 • ALMIN.1.2

CHF= hronic Heart Failure

CHF= Chronic Heart Failure