Indications for: TRIJARDY XR

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

Limitations of Use:

Not recommended in those with type 1 diabetes; may increase risk of diabetic ketoacidosis. Not studied in those with a history of pancreatitis.

Adult Dosage:

Swallow whole. Take once daily in the AM with food. Individualize. Currently on metformin (± linagliptin): switch to similar total daily dose plus empagliflozin 10mg and linagliptin 5mg. Currently on metformin and empagliflozin (± linagliptin): switch to similar total daily dose plus linagliptin 5mg. Max: 25mg/5mg/2000mg per day. Renal impairment: initiation is not recommended if eGFR <45mL/min/1.73m2.

Children Dosage:

<18yrs: not established.

TRIJARDY XR Contraindications:

Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.

Boxed Warning:

Lactic acidosis.

TRIJARDY XR Warnings/Precautions:

Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis is suspected or occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR <60mL/min/1.73m2, history of hepatic impairment, alcoholism, heart failure, or when intra-arterial contrast will be given; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Avoid if clinical or lab evidence of hepatic disease. Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy; more frequently in elderly. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Monitor for signs/symptoms of pancreatitis, hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs; monitor and treat as appropriate. Measure hematologic parameters annually (esp. serum Vit. B12 in susceptible patients). History of angioedema to other DPP-4 inhibitors. Known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Renal impairment. Hepatic impairment: not recommended. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

TRIJARDY XR Classification:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor + biguanide.

TRIJARDY XR Interactions:

Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels. Avoid excessive alcohol. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Greater potential for volume depletion with concomitant diuretics. May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Antagonized by strong P-gp or CYP3A4 inducers (eg, rifampin); consider alternatives to linagliptin if used in combination. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:

Upper RTI, UTI, nasopharyngitis, diarrhea, constipation, headache, gastroenteritis; genital mycotic infections (esp. females), hypersensitivity reactions, pancreatitis, heart failure, hypotension, ketoacidosis, renal impairment, urosepsis, pyelonephritis, possible severe and disabling arthralgia, bullous pemphigoid; rare: Fournier's gangrene.

Generic Drug Availability:


How Supplied:

Tabs 5mg/2.5mg/1000mg, 12.5mg/2.5mg/1000mg—60, 180; 10mg/5mg/1000mg, 25mg/5mg/1000mg—30, 90