For patients with T2D uncontrolled on dual therapy with metformin + DPP4i or metformin + SGLT2i 1
NOW PBS
LISTED 3
For patients with T2D uncontrolled on dual therapy with metformin + DPP4i or metformin + SGLT2i 1
JARDIANCE ® ( empagliflozin ) and TRAJENTA ® ( linagliptin ) now combined in a once daily tablet 1 , 2
For the battle against type 2 diabetes .
PBS Information : GLYXAMBI ® : Authority Required ( STREAMLINED ). Type 2 Diabetes . Code 7524 - Triple therapy , initial treatment ( with metformin ). Code 7556 - Triple therapy , continuing treatment ( with metformin ). 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
GLYXAMBI ® ( empagliflozin / linagliptin ) 10 / 5 mg , 25 / 5 mg film-coated tablets . INDICATIONS : As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate . CONTRAINDICATIONS : Hypersensitivity to empagliflozin or linagliptin or any of the excipients ; Patients with eGFR persistently < 45 mL / min / 1.73m 2 or CrCl persistently < 45 mL / min ( CKD Stage 3B ). PRECAUTIONS : Patients with type 1 diabetes ; diabetic ketoacidosis ; risk of hypoglycaemia when used in combination with sulfonylureas ( SU ) and / or insulin ; discontinue if pancreatitis is suspected ; discontinue when eGFR is persistently below 45mL / min / 1.73m 2 or CrCl < 45mL / min ; monitoring of renal function is recommended ; patients for whom a drop in BP could pose a risk ( e . g . those with known CV disease , on anti-hypertensive therapy with a history of hypotension , or aged ≥75 years ); consider discontinuation in patients with recurrent urinary tract infections ( UTIs ); discontinue if bullous pemphigoid is suspected ; pregnancy ; lactation ; children (< 18 years ). INTERACTIONS : Insulin and SU ; diuretics ; strong P-gp or CYP3A4 inducers . Others , see full PI . ADVERSE REACTIONS : Common : vaginal moniliasis , vulvovaginitis , balanitis and other genital infections ; UTI ; nasopharyngitis ; hypoglycaemia ( combination with SU or insulin ); increased urination ; cough ; rash ; pruritus ; lipase increased ; serum lipids increased . Others , see full PI . DOSAGE AND ADMINISTRATION : Recommended starting dose is 10mg / 5mg once daily taken with or without food . Patients tolerating 10mg / 5mg once daily and requiring additional glycaemic control , increase dose to 25 mg / 5mg once daily . Patients already on empagliflozin , the dose of GLYXAMBI should provide the dose of empagliflozin similar to the dose already taken . No dose adjustment is recommended : based on age ; patients with eGFR ≥45mL / min / 1.73m 2 ; patients with hepatic impairment . Initiation of GLYXAMBI is not recommended in patients aged ≥75 years . 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 2018 .
References : 1 . GLYXAMBI ® Approved Product Information . 2 . DeFronzo RA et al . Diabetes Care 2015 ; 38:384 – 93 . 3 . Pharmaceutical Benefits Scheme . Available at : www . pbs . gov . au . Accessed April 2018 .
Boehringer Ingelheim Pty Limited , ABN 52 000 452 308 78 Waterloo Road , North Ryde , NSW 2113 Australia . Copyright © 2018 BOEH0896RR _ AD _ FP . AU / DIA / 00145b . Prepared April 2018 .
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