CV DEATH HAS A NEW OPPONENT
JARDIANCE ®, the only type 2 diabetes agent approved to reduce the risk of CV death 1, 2
In patients with type 2 diabetes and established CV disease( CAD, PAD, MI or stroke) on top of standard of care 1
VS PLACEBO ON TOP OF STANDARD OF CARE 1, 2
PBS Information: JARDIANCE ®: Authority Required( STREAMLINED). Type 2 Diabetes. Code 4983 – Add-on to metformin or SU. Code 5629 – Triple therapy( with metformin and SU). Code 4991 – Add-on to insulin. Refer to PBS Schedule for full Authority Required Information.
BEFORE PRESCRIBING, PLEASE REVIEW THE FULL PRODUCT INFORMATION WHICH IS AVAILABLE ON REQUEST FROM BOEHRINGER INGELHEIM OR FROM WWW. BOEHRINGER-INGELHEIM. COM. AU / PI
JARDIANCE ®( empagliflozin) 10 mg, 25 mg film-coated tablets. INDICATIONS: Glycaemic control: Treatment of type 2 diabetes mellitus( T2DM) to improve glycaemic control in adults as: Monotherapy – When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance; Add-on combination therapy – With other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. Prevention of cardiovascular( CV) death: In patients with T2DM and established CV disease to reduce the risk of CV death. To prevent CV deaths, Jardiance should be used in conjunction with other measures to reduce CV risk in line with the current standard of care. CONTRAINDICATIONS: Hypersensitivity to empagliflozin or any of the excipients; patients with CKD stage 4 or 5( severely impaired renal function including patients receiving dialysis; eGFR < 30mL / min / 1.73 m 2 or CrCl < 30mL / min) or eGFR persistently < 45mL / min / 1.73 m 2 or CrCl persistently < 45mL / min( CKD stage 3B); rare hereditary conditions of galactose intolerance, e. g. galactosaemia. PRECAUTIONS: Patients with type 1 diabetes; diabetic ketoacidosis; discontinue when eGFR is persistently below 45mL / min / 1.73 m 2 or CrCl < 45mL / min; monitoring of renal function is recommended; consider discontinuation in patients with recurrent urinary tract infections( UTIs); patients for whom a drop in BP could pose a risk( e. g. those with known CV disease, on diuretics, have a history of hypotension, or aged ≥75 years); pregnancy; lactation; children(< 18 years). INTERACTIONS: Diuretics – may add to diuretic effect of thiazide and loop diuretics; insulin and sulfonylurea( SU) – may increase the risk of hypoglycaemia. ADVERSE REACTIONS: Very common: hypoglycaemia( combination with metformin and a SU; insulin). Common: hypoglycaemia( combination with metformin; pioglitazone with or without metformin; metformin and linagliptin); UTIs; increased urination; vaginal moniliasis, vulvovaginitis, balanitis and other genital infections; volume depletion( patients aged ≥ 75 years); thirst; serum lipids increased. Others, see full PI. DOSAGE AND ADMINISTRATION: Recommended starting dose is 10 mg once daily taken with or without food. Patients tolerating 10 mg once daily and require additional glycaemic control, increase dose to 25 mg once daily. No dose adjustment is necessary for patients: based on age; patients with hepatic impairment; patients with eGFR ≥ 45mL / min / 1.73 m 2. When used in combination with a SU or with insulin – A lower dose of the SU or insulin may be considered to reduce the risk of hypoglycaemia. Boehringer Ingelheim Pty Limited. ABN 52 000 452 308. 78 Waterloo Road North Ryde NSW 2113. January 2017.
References: 1. JARDIANCE ® Approved Product Information. 2. Zinman B, et al. N Engl J Med. 2015; 373:2117-28.
NEW INDICATION
PREVENTION OF CV DEATH
Standard of care included antihypertensives, lipid-lowering agents, anticoagulants and glucose-lowering therapies. 2 The absolute risk for CV death was 5.9 % in patients receiving standard of care plus placebo and was reduced to 3.7 % in patients receiving standard of care plus JARDIANCE ®( p < 0.001). 2
RRR = relative risk reduction; HR = hazard ratio; CAD = coronary artery disease; PAD = peripheral artery disease; MI = myocardial infarction.
Boehringer Ingelheim Pty Limited, ABN 52 000 452 308 78 Waterloo Road, North Ryde, NSW 2113 Australia. Copyright © 2017 ELI3822 _ AD AU / EMP / 00137( 1) Prepared April 2017.
Eli Lilly Australia Pty Limited, ABN 39 000 233 992 112 Wharf Road, West Ryde, NSW 2114 Australia
Copyright © 2017.