Diabetes:

Indications for TRIJARDY XR:

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Limitations of Use:

Not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in patients with a history of pancreatitis.

Adult:

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 (eGFR <45mL/min/1.73m2): do not initiate or continue treatment.

Children:

<18yrs: not established.

Contraindications:

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

Boxed Warning:

Lactic acidosis.

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 and assess for volume contraction before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment, low systolic BP, or on diuretics). 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). Evaluate renal function prior to starting and monitor periodically thereafter; more frequently in elderly or patients with eGFR <60mL/min/1.73m2. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. 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. Monitor for genital mycotic infections, UTIs; treat as appropriate. Measure hematologic parameters annually (esp. serum Vit. B12 in susceptible patients). History of angioedema to other DPP-4 inhibitors. Renal impairment. Hepatic impairment: not recommended. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacologic Class:

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

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 Availability:

NO

How Supplied:

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

Pricing for TRIJARDY XR

12.5mg/2.5mg/1000mg tablet (Qty: 60)
Appx. price $543
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