≥30 mL / min / 1.73m 2 ( 1 )
Simple flexibility . * 1
* Always TRAJENTA ® ( linagliptin ) 2.5mg bd with your choice of metformin dose . 1
500
2.5mg linagliptin bd mg metformin HCI
850
2.5mg linagliptin bd mg metformin HCI
1000
2.5mg linagliptin bd mg metformin HCI
FOR PATIENTS WITH T2D UNCONTROLLED ON METFORMIN 1
PBS Information : TRAJENTAMET ® : Authority Required ( STREAMLINED ). Type 2 Diabetes . Code 6333 – After metformin ( for patients who are on metformin and are switched to TRAJENTAMET ® ). Code 6336 – Dual therapy , continuing ( for patients who are on metformin and TRAJENTA ® or continuing on TRAJENTAMET ® ). Code 6344 – Triple therapy ( with SU ). Code 6443 – Add-on to insulin . Code 7507 – Triple therapy , initial treatment ( with SGLT2i ). Code 7530 – Triple therapy , continuing treatment ( with SGLT2i ). 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
TRAJENTAMET ® ( linagliptin / metformin hydrochloride ) 2.5mg / 500mg , 2.5mg / 850mg , 2.5mg / 1000mg film-coated tablets . INDICATION : As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate , in patients inadequately controlled on metformin alone , or those already being treated and well controlled with the combination of linagliptin and metformin . In combination with a sulfonylurea ( i . e ., triple combination therapy ) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea . In combination with an SGLT2 inhibitor ( i . e ., triple combination therapy ) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an SGLT2 inhibitor . In combination with insulin ( i . e ., triple combination therapy ) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate control . CONTRAINDICATIONS : Hypersensitivity to linagliptin and / or metformin hydrochloride or to the excipients ; metabolic acidosis ( e . g . lactic acidosis , diabetic ketoacidosis ); diabetic pre-coma ; severe renal failure ( CrCL < 30 mL / min or eGFR < 30 mL / min / 1.73m 2 ), which may result from cardiovascular collapse ( shock ), acute myocardial infarction ( MI ), and septicaemia ; acute conditions with potential to alter renal function ( e . g . dehydration , severe infection , shock , intravascular administration of iodinated contrast agents ); acute or chronic disease which may cause tissue hypoxia ( e . g . cardiac or respiratory failure , recent MI , shock , pulmonary embolism , acute significant blood loss , sepsis , gangrene , pancreatitis ); during or immediately following surgery where insulin is essential ; elective major surgery ; hepatic impairment , acute alcohol intoxication , alcoholism ( due to the metformin component ); lactation . PRECAUTIONS : Patients with type 1 diabetes ; discontinue if pancreatitis is suspected ; hypoglycaemia ( when used in combination with a sulfonylurea or insulin ); lactic acidosis , decreased renal function ; discontinue temporarily in patients undergoing radiologic studies involving administration of iodinated contrast materials ; surgery ; discontinue if bullous pemphigoid is suspected ; arthralgia , reduction in Vitamin B12 levels ; pregnancy ; lactation ; children (< 18 years ); others , see full PI . INTERACTIONS : Alcohol ; glucocorticoids ; tetracosactides ; beta-2- agonists ; danazol ; high dose chlorpromazine ( 100mg / day ); diuretics ; ACE-inhibitors ; angiotensin II receptor antagonists ; calcium channel blockers ; beta-blockers ; cimetidine ; vitamin K antagonists ; nifedipine ; organic cation transporters ; antagonised by strong P-gp or CYP3A4 inducers ; NSAIDs ( including selective COX II inhibitors ), carbonic anhydrase inhibitors . ADVERSE REACTIONS : Very common : diarrhoea , nausea , vomiting , abdominal pain , decreased appetite ; combination with a sulfonylurea and combination with insulin – hypoglycaemia ; Common : nasopharyngitis , diarrhoea , taste disturbance , increase in lipase . Others , see full PI . DOSAGE AND ADMINISTRATION : One tablet taken twice daily with meals . Maximum recommended daily dose is 5 mg of linagliptin and 2000 mg of metformin . For patients inadequately controlled on maximal tolerated dose of metformin alone : The usual starting dose should provide linagliptin dosed as 2.5 mg twice daily ( 5 mg total daily dose ) plus the dose of metformin already being taken . For patients switching from co-administration of linagliptin and metformin to the fixed dose combination : Initiate at the dose of linagliptin and metformin already being taken . For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulfonylurea : The dose should provide linagliptin dosed as 2.5 mg twice daily ( 5 mg total daily dose ) and a dose of metformin similar to the dose already being taken . When used in combination with a sulfonylurea , a lower dose of the sulfonylurea may be required to reduce the risk of hypoglycaemia . For patients inadequately controlled on dual combination therapy with insulin and metformin : The dose should provide linagliptin dosed as 2.5 mg twice daily ( 5 mg total daily dose ) and a dose of metformin similar to the dose already being taken . When used in combination with insulin , a lower dose of insulin may be required to reduce the risk of hypoglycaemia . Boehringer Ingelheim Pty Limited . ABN 52 000 452 308 . 78 Waterloo Road North Ryde NSW 2113 . August 2020 .
Abbreviations : bd , twice daily ; T2D , type 2 diabetes .
Life threatening lactic acidosis can occur due to accumulation of metformin . Risk factors include renal impairment , old age and the use of high doses of metformin above 2000 mg per day .
Reference : 1 . TRAJENTAMET ® Product Information . August 2020 .
Boehringer Ingelheim Pty Limited , ABN 52 000 452 308 . 78 Waterloo Road , North Ryde , NSW 2113 Australia . Copyright © 2021 . BOEH1372 _ AD _ FP . PC-AU-102146 . Prepared June 2021 .