TRIJARDY XR

TRIJARDY XR is the brand name for empagliflozin, linagliptin, and metformin and is available as an extended-release oral tablet.

TRIJARDY XR is available as an extended-release oral tablet that contains:

• 5 mg empagliflozin/2.5 mg linagliptin/1,000 mg metformin
• 10 mg empagliflozin/5 mg linagliptin/1,000 mg metformin
• 2.5 mg empagliflozin/2.5 mg linagliptin/1,000 mg metformin
• 25 mg empagliflozin/5 mg linagliptin/1,000 mg metformin

• TRIJARDY XR is a SGLT2/DPP-4 inhibitor/biguanide combination that is used to treat type 2 diabetes

TRIJARDY XR is a combination of three diabetes medications that work together to lower your blood sugar:
Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor. It allows your body to get rid of excess sugar through the urine by lowering the amount of sugar that gets absorbed back into your kidneys. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that raises the amount of insulin your body makes. Metformin is a biguanide that lowers the amount of sugar your liver makes, lowers the amount of sugar your stomach absorbs, and helps you respond better to insulin.

• The starting dose of TRIJARDY XR will depend on the doses of your previous diabetes medications. TRIJARDY XR should be taken by mouth once a day in the morning with a meal. Your provider might adjust your dose depending on how you respond to the medication. Don’t take more than 25 mg/5 mg/2,000 mg (empagliflozin/linagliptin/metformin) total per day

TRIJARDY XR is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• Severe renal impairment (eGFR below 30 mL/min/1.73 m2), end-stage renal disease, or on dialysis.
• Metabolic acidosis, including diabetic ketoacidosis.
• Hypersensitivity to empagliflozin, linagliptin, metformin, or any of the excipients in TRIJARDY XR

Common side effects of TRIJARDY XR:

• Upper respiratory tract infection
• Urinary tract infection
• Common cold
• Diarrhea
• Constipation
• Headache
• Stomach flu (gastroenteritis)
• Low blood sugar
• Frequent urination

Serious side effects are rare with TRIJARDY XR. Contact your healthcare provider immediately if you experience any of the following.

• Lactic acidosis (buildup of lactic acid): unusual muscle pain, difficulty breathing, unusual sleepiness, stomach pain, feeling cold in hands or feet, low blood pressure, slow heart rate, very weak or tired
• Pancreatitis (inflammation of the pancreas): severe stomach pain that doesn’t go away, pain that starts from the stomach and wraps to the back, sometimes vomiting
• Ketoacidosis (buildup of ketones): dehydration, nausea, vomiting, stomach pain, tiredness, shortness of breath
• Heart failure: shortness of breath, sudden fast weight gain, swelling of the feet
• Kidney problems: low urine production, swelling in the legs, nausea, tiredness, shortness of breath
• Fournier’s gangrene (flesh-eating bacterial infection of the genitals): fever or discomfort along with pain, tenderness, redness, or swelling in the genital area
  Serious skin reactions: fluid-filled blisters, top layer of your skin looks like it’s breaking down
• Serious allergic reactions: rash, hives, swelling of the face, lips, tongue, and throat that causes difficulty breathing or difficulty swallowing

The following medications may interact with TRIJARDY XR:

• Carbonic Anhydrase Inhibitors: May increase risk of lactic acidosis
• Consider more frequent monitoring
• Drugs that Reduce Metformin Clearance: May increase risk of lactic acidosis. Consider benefits and risks of concomitant use. See full prescribing information for additional drug interactions and information on interference of TRIJARDY XR with laboratory tests

Boehringer Ingelheim Pharmaceuticals, Inc.

Based on animal data showing adverse renal effects from empagliflozin, TRIJARDY XR is not recommended during the second and third trimesters of pregnancy. You should talk to your healthcare provider before taking this medication if you are pregnant.