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 .
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