Jentadueto linagliptin and metformin hydrochloride 2.5 mg; 500 mg Tablet, Film Coated, 180-count

1 INDICATIONS AND USAGE JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Limitations of Use JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis.

It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2) ]. JENTADUETO is a combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Limitations of Use Not recommended in patients with type 1 diabetes mellitus ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 )

2 DOSAGE AND ADMINISTRATION Individualize the starting dosage of JENTADUETO based on the patient's current regimen ( 2.1 ) The maximum recommended dosage is 2.5 mg linagliptin/1,000 mg metformin HCl twice daily ( 2.1 ) Take orally twice daily with meals, with gradual dosage escalation to reduce the gastrointestinal effects due to metformin ( 2.1 ) Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) Do not use in patients with eGFR below 30 mL/min/1.73 m 2 Initiation is not recommended in patients with eGFR between 30 - 45 mL/min/1.73 m 2 Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m 2 Discontinue if eGFR falls below 30 mL/min/1.73 m 2 JENTADUETO may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.3 )

2.1Recommended Dosage and Administration The dosage of JENTADUETO should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended dosage of 2.5 mg linagliptin/1,000 mg metformin hydrochloride (HCl), taken orally twice daily. JENTADUETO should be given twice daily with meals. Dosage escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with metformin use.

Recommended starting dosage: In patients currently not treated with metformin HCl, initiate treatment with 2.5 mg linagliptin/500 mg metformin HCl twice daily. In patients already treated with metformin HCl, start with 2.5 mg linagliptin and the current dosage of metformin HCl taken at each of the two daily meals (e.g., a patient on metformin HCl 1,000 mg twice daily would be started on 2.5 mg linagliptin/1,000 mg metformin HCl twice daily with meals). Patients already treated with linagliptin and metformin HCl individual components may be switched to JENTADUETO containing the same dosages of each component.

2.2Recommended Dosing in Renal Impairment Assess renal function prior to initiation of JENTADUETO and periodically thereafter. JENTADUETO is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2 . Initiation of JENTADUETO in patients with an eGFR between 30-45 mL/min/1.73 m 2 is not recommended.

In patients taking JENTADUETO whose eGFR later falls below 45 mL/min/1.73 m 2 , assess benefit/risk of continuing therapy. Discontinue JENTADUETO if the patient's eGFR later falls below 30 mL/min/1.73 m 2 [see Contraindications (4) and Warnings and Precautions (5.1) ].

2.3Discontinuation for Iodinated Contrast Imaging Procedures Discontinue JENTADUETO at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart JENTADUETO if renal function is stable [see Warnings and Precautions (5.1) ].

3 DOSAGE FORMS AND STRENGTHS JENTADUETO tablets are a combination of linagliptin and metformin HCl available as: 2.5 mg linagliptin/500 mg metformin HCl tablets are light yellow, oval, biconvex tablets debossed with "D2/500" on one side and the Boehringer Ingelheim symbol on the other side 2.5 mg linagliptin/850 mg metformin HCl tablets are light orange, oval, biconvex tablets debossed with "D2/850" on one side and the Boehringer Ingelheim symbol on the other side 2.5 mg linagliptin/1,000 mg metformin HCl tablets are light pink, oval, biconvex tablets debossed with "D2/1000" on one side and the Boehringer Ingelheim symbol on the other side Tablets: 2.5 mg linagliptin/500 mg metformin HCl ( 3 ) 2.5 mg linagliptin/850 mg metformin HCl ( 3 ) 2.5 mg linagliptin/1,000 mg metformin HCl ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) Lactic Acidosis Inform patients of the risks of lactic acidosis due to metformin, its symptoms, and conditions that predispose to its development. Advise patients to discontinue JENTADUETO immediately and to notify their healthcare provider promptly if unexplained hyperventilation, malaise, myalgia, unusual somnolence, or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving JENTADUETO.

Instruct patients to inform their healthcare provider that they are taking JENTADUETO prior to any surgical or radiological procedure, as temporary discontinuation may be required until renal function has been confirmed to be normal [see Warnings and Precautions (5.1) ] . Pancreatitis Inform patients that acute pancreatitis has been reported during use of linagliptin. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis.

Instruct patients to discontinue JENTADUETO promptly and contact their healthcare provider if persistent severe abdominal pain occurs [see Warnings and Precautions (5.2) ] . Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Inform patients that the risk of hypoglycemia is increased when JENTADUETO is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin [see Warnings and Precautions (5.3) ] . Hypersensitivity Reactions Inform patients that serious allergic reactions, such as anaphylaxis, angioedema, and exfoliative skin conditions, have been reported during postmarketing use of linagliptin (one of the components of JENTADUETO).

If symptoms of allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JENTADUETO and seek medical advice promptly [see Warnings and Precautions (5.4) ] . Vitamin B 12 Deficiency Inform patients about the importance of regular hematological parameters while receiving JENTADUETO [see Warnings and Precautions (5.5) ] . Severe and Disabling Arthralgia Inform patients that severe and disabling joint pain may occur with this class of drugs.

The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see Warnings and Precautions (5.6) ]. Bullous Pemphigoid Inform patients that bullous pemphigoid has been reported during use of linagliptin.

Instruct patients to seek medical advice if blisters or erosions occur [see Warnings and Precautions (5.7) ]. Heart Failure Inform patients of the signs and symptoms of heart failure. Before initiating JENTADUETO, patients should be asked about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment.

Instruct patients to contact their healthcare provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.8) ]. Patients of Reproductive Potential Inform patients that treatment with metformin may result in ovulation in some premenopausal anovulatory patients, which may lead to unintended pregnancy [see Use in Specific Populations (8.3) ] . Missed Dose Instruct patients to take JENTADUETO only as prescribed.

If a dose is missed, it should be taken as soon as the patient remembers. Advise patients not to double their next dose.

MEDICATION GUIDE JENTADUETO ® (JEN ta doo e toe) (linagliptin and metformin hydrochloride tablets) for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: August 2026 What is the most important information I should know about JENTADUETO?

JENTADUETO can cause serious side effects, including: 1. Lactic acidosis. Metformin hydrochloride (HCl), one of the medicines in JENTADUETO, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death.

Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking JENTADUETO and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis: feel very weak and tired have unusual (not normal) muscle pain have trouble breathing have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea have unusual sleepiness or sleep longer than usual feel cold, especially in your arms and legs feel dizzy or lightheaded have a slow or irregular heartbeat You have a higher chance of getting lactic acidosis with JENTADUETO if you: have severe kidney problems. have liver problems. drink a lot of alcohol (very often or short-term "binge" drinking). get dehydrated (lose a large amount of body fluids).

This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids. have certain x-ray tests with injectable dyes or contrast agents. have surgery or other procedures for which you need to restrict the amount of food and liquid you eat and drink. have congestive heart failure. have a heart attack, severe infection, or stroke. are 65 years of age or older. have a genetically inherited disease affecting mitochondria (the energy-producing parts within cells) such as mitochondrial encephalomyopathy with lactic acidosis, and stroke-like episodes (MELAS) syndrome and maternally inherited diabetes and deafness (MIDD).

Tell your healthcare provider if you have any of the problems in the list above. Tell your healthcare provider that you are taking JENTADUETO before you have surgery or x-ray tests. Your healthcare provider may decide to stop your JENTADUETO for a while if you have surgery or certain x-ray tests.

JENTADUETO can have other serious side effects. See " What are the possible side effects of JENTADUETO? " 2. Inflammation of the pancreas (pancreatitis) which may be severe and lead to death.

Certain medical problems make you more likely to get pancreatitis. Before you start taking JENTADUETO, tell your healthcare provider if you have ever had: inflammation of your pancreas (pancreatitis) a history of alcoholism stones in your gallbladder (gallstones) high blood triglyceride levels Stop taking JENTADUETO and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back.

The pain may happen with or without vomiting. These may be symptoms of pancreatitis. What is JENTADUETO?

JENTADUETO is a prescription medicine that contains 2 diabetes medicines, linagliptin (TRADJENTA) and metformin HCl. JENTADUETO can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus. JENTADUETO is not for people with type 1 diabetes mellitus.

If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO. It is not known if JENTADUETO is safe and effective in children. Who should not take JENTADUETO?

Do not take JENTADUETO if you: have severe kidney problems. have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine). are allergic to linagliptin (TRADJENTA), metformin, or any of the ingredients in JENTADUETO. See the…