FDA approved Trijardy XR (empagliflozin, linagliptin, metformin HCl) for Type 2 DiabetesFDA approved new combination pill Trijardy XR for type 2 diabetes

Trijardy XR combines three antihyperglycemic agents with complementary mechanisms: empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, reduces renal glucose reabsorption, increasing urinary glucose excretion; linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, increases incretin hormones, enhancing glucose-dependent insulin secretion and lowering glucagon; metformin HCl, a biguanide, decreases hepatic glucose production and improves insulin sensitivity.

Trijardy XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. Limitations of use: not recommended for improving glycemic control in patients with type 1 diabetes mellitus due to increased risk of diabetic ketoacidosis; not studied in patients with a history of pancreatitis.

Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. Individualize starting dosage based on current regimen and renal function. Initiation is not recommended in patients with eGFR less than 45 mL/min/1.73 m² due to metformin component. Maximum recommended dosage is 25 mg empagliflozin, 5 mg linagliptin, and 2,000 mg metformin HCl. Take once daily with a meal in the morning. Swallow whole; do not split, crush, dissolve, or chew. Discontinue at time of or prior to iodinated contrast imaging in certain patients; re-evaluate eGFR 48 hours after procedure. Withhold for at least 3 days prior to surgery or procedures associated with prolonged fasting.

A double-blind, active-controlled trial enrolled 686 patients with type 2 diabetes inadequately controlled on at least 1,500 mg metformin HCl per day. The trial evaluated empagliflozin 10 mg or 25 mg in combination with linagliptin 5 mg compared to individual components. The label states that the combination improved glycemic control, but specific efficacy data are not provided in the label excerpt.

Contraindicated in patients with eGFR less than 30 mL/min/1.73 m². Not recommended for type 1 diabetes mellitus. Warnings include risk of diabetic ketoacidosis, pancreatitis (unknown risk in patients with history), and need to assess renal function and volume status. Discontinue for iodinated contrast imaging in patients with eGFR <60 mL/min/1.73 m², liver disease, alcoholism, heart failure, or intra-arterial contrast. Withhold for surgery with prolonged fasting.

Trijardy XR is a fixed-dose combination that may be used as an adjunct to diet and exercise in adults with type 2 diabetes who require multiple agents. It may be particularly relevant for patients with established cardiovascular disease, given the empagliflozin indication to reduce cardiovascular death. However, it is not recommended for type 1 diabetes and has not been studied in patients with a history of pancreatitis. Clinicians should consider renal function and volume status before prescribing.