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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JENTADUETO or JENTADUETO XR?

JENTADUETO and JENTADUETO XR can cause serious side effects, including Lactic Acidosis (a build-up of lactic acid in the blood). Metformin, one of the medicines in JENTADUETO and JENTADUETO XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking JENTADUETO or JENTADUETO XR and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms, which could be signs of lactic acidosis: feel very weak and tired, have unusual muscle pain, have trouble breathing, have stomach or intestinal problems with nausea and vomiting, or diarrhea, feel sleepy or sleep longer than usual, feel cold in your arms and legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis with JENTADUETO or JENTADUETO XR if you have severe kidney problems, liver problems, drink a lot of alcohol (very often or short-term "binge" drinking), get dehydrated (lose a large amount of body fluids), have x-ray tests with injectable dye, have surgery, have congestive heart failure, have a heart attack, severe infection, or stroke, or are 65 years of age or older.

Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO or JENTADUETO XR. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO or JENTADUETO XR tell your healthcare provider if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking JENTADUETO or JENTADUETO XR 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 through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Who should not take JENTADUETO or JENTADUETO XR?

Do not take JENTADUETO or JENTADUETO XR 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 or JENTADUETO XR. Symptoms of an allergic reaction may include rash, itching, flaking, or peeling; raised red patches on your skin (hives); and swelling of your face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking JENTADUETO or JENTADUETO XR and call your healthcare provider right away or go to the nearest hospital emergency room.

What should I tell my healthcare provider before using JENTADUETO or JENTADUETO XR?

Tell your healthcare provider about all of your medical conditions, including if you:

• have or have had inflammation of your pancreas (pancreatitis)
• have kidney problems
• have liver problems
• have heart problems, including congestive heart failure
• are 65 years of age or older
• drink alcohol very often, or drink a lot of alcohol in short term ("binge" drinking)
• are going to get an injection of dye or contrast agents for an x-ray procedure. JENTADUETO or JENTADUETO XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop JENTADUETO or JENTADUETO XR and when you should start JENTADUETO or JENTADUETO XR again
• have type 1 diabetes. JENTADUETO or JENTADUETO XR should not be used in people with type 1 diabetes
• have low levels of vitamin B₁₂ in your blood
• are pregnant or planning to become pregnant. It is not known if JENTADUETO or JENTADUETO XR will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if JENTADUETO or JENTADUETO XR passes into your breast milk
• are a person who has not gone through menopause (premenopausal) who does not have periods regularly or at all. JENTADUETO or JENTADUETO XR can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant. Tell your healthcare provider right away if you become pregnant while taking JENTADUETO or JENTADUETO XR.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO or JENTADUETO XR may affect the way other medicines work, and other medicines may affect how JENTADUETO or JENTADUETO XR works.

Especially tell your healthcare provider if you take:

• insulin or other medicines that can lower your blood sugar
• rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis.

What are the possible side effects of JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR may cause serious side effects, including:

• Lactic acidosis (a build-up of lactic acid in the blood).
• Pancreatitis (an inflammation of the pancreas).
• Low blood sugar (hypoglycemia). If you take JENTADUETO or JENTADUETO XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take JENTADUETO or JENTADUETO XR. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, fast heartbeat, sweating, or feeling jittery.
• Allergic (hypersensitivity) reactions have happened in people taking JENTADUETO or JENTADUETO XR. Symptoms may include swelling of your face, lips, tongue, throat, and other areas on your skin; difficulty with swallowing or breathing; raised, red areas on your skin (hives); skin rash, itching, flaking, or peeling. If you have any of these symptoms, stop taking JENTADUETO or JENTADUETO XR and call your healthcare provider or go to the emergency room right away.
• Low vitamin B₁₂ (vitamin B₁₂ deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B₁₂ in your blood, especially if you have had low vitamin B₁₂ blood levels before. Your healthcare provider may do blood tests to check your vitamin B₁₂ levels.
• Joint pain. Some people who take medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors, one of the medicines in JENTADUETO and JENTADUETO XR, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.
• Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JENTADUETO and JENTADUETO XR, may develop a skin reaction. Tell your healthcare provider right away if you develop blisters.
• Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking JENTADUETO or JENTADUETO XR, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.

The most common side effects of JENTADUETO and JENTADUETO XR include stuffy or runny nose, sore throat, and diarrhea.

These are not all the possible side effects of JENTADUETO and JENTADUETO XR. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑10881‑800‑FDA‑1088.

CL-JD-100033 4.22.2022

Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO.
Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO XR.