2 JUNE 2023 ausdoc . com . au

PBS Information : JARDIANCE ® : Authority Required ( STREAMLINED ). Type 2 Diabetes . Code 7506 - Add-on to metformin or SU . Code 4991 - Add-on to Insulin . Code 5629 - Triple therapy ( with metformin and SU ). Code 7528 - Triple therapy , initial treatment ( with metformin + DPP4i ). Code 7495 - Triple therapy , continuing treatment ( with metformin + DPP4i ). Refer to PBS Schedule for full Authority Required Information .

BEFORE PRESCRIBING , PLEASE REVIEW THE FULL PRODUCT INFORMATION AVAILABLE FROM BOEHRINGER INGELHEIM AT 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 ; for the treatment of T2DM - JARDIANCE should not be used in patients with severe renal impairment ( eGFR < 30mL / min / 1.73m 2 ) as glycaemic efficacy depends on renal function ; rare hereditary conditions of galactose intolerance , e . g . galactosaemia . PRECAUTIONS : Patients with type 1 diabetes ; ketoacidosis ; surgery ; patients with T2DM - contraindicated when eGFR is below 30mL / min / 1.73m 2 ; monitoring of renal function is recommended ; consider discontinuation in patients with recurrent complicated urinary tract infections ( UTIs ); necrotising fasciitis of the perineum ( Fournier ’ s gangrene ); 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 ; interference with 1,5-anhydroglucitol assay ; lithium - may decrease blood lithium levels . ADVERSE REACTIONS : Very common : hypoglycaemia ( combination with metformin and an 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 ; pruritis ; serum lipids increased ; constipation . Others , see full PI . DOSAGE AND ADMINISTRATION : JARDIANCE can be taken with or without food . The recommended starting dose is 10mg once daily . For patients tolerating 10mg once daily and require additional glycaemic control , increase dose to 25mg once daily . No dose adjustment is necessary for patients based on age , patients treated for T2DM with eGFR ≥30mL / min / 1.73m 2 or hepatic impairment . When used in combination with an SU or insulin , a lower dose of the SU or insulin may be considered to reduce the risk of hypoglycaemia . September 2022 .

References : 1 . JARDIANCE ® Product Information . 2 . Zinman B et al . N Engl J Med 2015 ; 373:2117 – 28 . 3 . Wanner C et al . N Engl J Med 2016 ; 375:323-34 .

Abbreviations : 3P-MACE = 3-point major adverse cardiac event ; CAD = coronary artery disease ; CI = confidence interval ; CV = cardiovascular ; HHF = hospitalisation for heart failure ; HR = hazard ratio ; MDRD = Modification of Diet in Renal Disease ; MI = myocardial infarction ; PAD = peripheral artery disease ; RRR = relative risk reduction .

Boehringer Ingelheim Pty Limited , ABN 52 000 452 308 78 Waterloo Road , North Ryde , NSW 2113 Australia . Copyright © 2023 . ELI4658 _ ADG _ A4SP4C . PC-AU-103227 . Prepared January 2023 .

In patients with type 2 diabetes and established CV disease ( CAD , PAD , MI or stroke ) on top of standard of care *

‡

Indication

Not actual patient .

HR = 0.62 95 % CI : 0.49 , 0.77 ; p < 0.001 . 1 , 2

IN HOSPITALISATION FOR HEART FAILURE 1 , 2 †*

HR = 0.65 95 % CI : 0.5 , 0.85 ; p = 0.002 1 , 2

Additional benefits

†

Secondary endpoint . Not indicated , see full PI for further information . 1

Eli Lilly Australia Pty Limited , ABN 39 000 233 992

112 Wharf Road , West Ryde , NSW 2114 Australia . Copyright © 2023 .

IN NEW OR WORSENING

NEPHROPATHY 2 , 3 †*#

HR = 0.61 95 % CI : 0.68 , 0.70 ; p < 0.001 . 3

* Standard of care included antihypertensives , lipid-lowering agents , anticoagulants and glucose-lowering therapies . Absolute risk for placebo vs JARDIANCE ® ( on a background of standard of care ): CV death : 5.9 % vs 3.7 %; HHF : 4.1 % vs 2.7 % and new or worsening nephropathy : 18.8 % vs 12.7 %. Secondary endpoints . Primary endpoint of 3P MACE was met , HR 0.86 , ( 95 % CI : 0.74,0.99 ) p = 0.04 , for superiority . 2

#

Defined as progression to macroalbuminuria ( urinary albumin-to-creatinine ratio , > 300 mg of albumin per gram of creatinine ); a doubling of the serum creatinine level , accompanied by an eGFR of ≤45 mL / min / 1.73 m 2 , as calculated by the MDRD formula ; the initiation of renal-replacement therapy ; or death from renal disease . 3

AHPRA cuts investigations by 80 %

Heather Saxena THE Medical Board of Australia says it has cut the number of complaints progressing to full-blown investigations by around 80 % in less than two years .

New investigations per month fell from an average of 114 between July 2021 and March 2022 to an average of 25 between May 2022 and February 2023 , showed data provided to Australian Doctor .

AHPRA said it hoped the numbers would fall further thanks to legal changes that began on 14 May allowing doctors to share patient records with the watchdog without risking a breach of patient privacy .

Referring to the reductions , a spokesperson added : “ We have sought to limit the use of investigations to serious allegations that could amount to referral to an independent panel or tribunal .

“ For less serious concerns , we are focused on understanding risks and whether there are sufficient controls in place to manage them .”

AHPRA general counsel Dr Jamie Orchard ( PhD ) said doctors ’ ability to share patient records meant formal investigations could be avoided if obtaining one single piece of information “ might determine the matter can be resolved ”.

“ We might go to the practitioner [ saying ] we just need to have a look at a particular record , and if we can satisfy ourselves by reference to that , we can close the matter down and it doesn ’ t need to travel into investigation .

“ It provides us with an opportunity to resolve some of those straightforward matters at a much earlier stage .”

AHPRA said the change would also hopefully cut the time it took to deal with complaints against practitioners — currently , 89 days on average .