* Always 5mg once daily 1
Proven CV safety . 2 †
In a dedicated CVOT ‡
3P-MACE , non-inferiority vs placebo on top of standard of care . HR : 1.02 ( 95 % CI , 0.89 , 1.17 )
†
CARMELINA ® evaluated cardiovascular and renal safety in patients with T2D and high cardio-renal risk . 2 §
3P-MACE , composite of CV death , non-fatal MI and non-fatal stroke . ‡ CVOT ; Cardiovascular outcomes trial . § High CV risk ( history of vascular disease and urine-albumin creatinine ratio [ UACR ] > 200 mg / g ), and high renal risk ( reduced eGFR and micro- or macroalbuminuria ).
PBS Information : TRAJENTA ® : Authority Required ( STREAMLINED ). Type 2 Diabetes . Code 6346 – Add-on to metformin or SU . Code 6363 – Triple therapy ( with metformin and SU ). Code 6376 – Add-on to insulin . Code 7541 – Triple therapy , initial treatment ( with metformin + SGLT2i ). Code 7505 – Triple therapy , continuing treatment ( with metformin + SGLT2i ). Refer to PBS Schedule for full Authority Required Information .
BEFORE PRESCRIBING , PLEASE REVIEW THE FULL PRODUCT INFORMATION WHICH IS AVAILABLE FROM BOEHRINGER INGELHEIM AT WWW . BOEHRINGER-INGELHEIM . COM . AU / PI .
TRAJENTA ® ( linagliptin ) 5mg film-coated tablets . INDICATION : Trajenta is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise . Monotherapy when metformin and sulfonylureas are not tolerated , or are contraindicated . Add on to metformin , sulfonylureas or metformin plus sulfonylureas , or to insulin ( with or without metformin ). Add on to metformin plus SGLT2 inhibitors . CONTRAINDICATIONS : Hypersensitivity to linagliptin or to the excipients . PRECAUTIONS : Not for use in type 1 diabetes , diabetic ketoacidosis . Discontinue if pancreatitis or bullous pemphigoid is suspected . Risk of hypoglycaemia when used in combination with sulfonylureas and insulin ; arthralgia , pregnancy ; lactation ; children < 18 years . INTERACTIONS : Antagonised by strong P-gp or CYP3A4 inducers . Others , see full PI . ADVERSE REACTIONS : Very common : combination with metformin and a sulfonylurea and combination with insulin – hypoglycaemia ; Common : increase in uric acid , increase in lipase ; combination with metformin – arthralgia , back pain , headache ; combination with a sulfonylurea – nasopharyngitis , hypertriglyceridaemia , urinary tract infections ; combination with metformin and a sulfonylurea – cough . Others , see full PI . DOSAGE AND ADMINISTRATION : 5 mg once daily taken with or without food . No dose adjustment is necessary for the elderly , or patients with renal or hepatic impairment . Boehringer Ingelheim Pty Limited . ABN 52 000 452 308 . 78 Waterloo Road North Ryde NSW 2113 . March 2020 .
References : 1 . TRAJENTA ® Product Information . 2 . Rosenstock J et al . JAMA 2019 ; 321:69-79 .
Boehringer Ingelheim Pty Limited , ABN 52 000 452 308 . 78 Waterloo Road , North Ryde , NSW 2113 Australia . Copyright © 2021 . BOEH1326 _ AD _ FP . PC-AU-101871 . Prepared February 2021 .