IMPORTANT SAFETY INFORMATION

Do not take GLYXAMBI if you are on dialysis.

Do not take GLYXAMBI if you are allergic to linagliptin (TRADJENTA), empagliflozin (JARDIANCE), or any of the ingredients in GLYXAMBI.

GLYXAMBI can cause serious side effects, including:

• Inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking GLYXAMBI, tell your healthcare provider if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.Stop taking GLYXAMBI 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.
• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition, which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking GLYXAMBI, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with GLYXAMBI. Stop taking GLYXAMBI and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms and, if possible, check for ketones in your urine:
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing
• Dehydration. GLYXAMBI can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking GLYXAMBI. You may be at higher risk of dehydration if you take medicines to lower your blood pressure, including water pills (diuretics), are on a low salt diet, have kidney problems, or are 65 years of age or older. Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat or start to lose liquids from your body from vomiting, diarrhea or being in the sun too long.
• Serious urinary tract infections. Serious urinary tract infections can occur in people taking GLYXAMBI and may lead to hospitalization. Tell your healthcare provider if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea, or vomiting.
• Low blood sugar (hypoglycemia). If you take GLYXAMBI 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 or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, confusion, irritability, hunger, fast heartbeat, sweating, dizziness, or shaking or feeling jittery.
• Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take GLYXAMBI, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have a fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
• Vaginal yeast infection. Talk to your healthcare provider if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
• Yeast infection of the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your healthcare provider if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.
• Allergic (hypersensitivity) reactions. Symptoms of a serious allergic reaction to GLYXAMBI 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 GLYXAMBI and call your healthcare provider right away or go to the emergency room.
• Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in GLYXAMBI, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.
• Skin reaction called bullous pemphigoid can be serious and may need to be treated in a hospital. 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 GLYXAMBI, 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 GLYXAMBI include urinary tract infections, stuffy or runny nose and sore throat, and upper respiratory tract infections.

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

Before taking GLYXAMBI, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems
• have liver problems
• have a history of infection of the vagina or penis
• have a history of urinary tract infections or problems with urination
• are going to have surgery. Your healthcare provider may stop your GLYXAMBI before you have surgery. Talk to your healthcare provider about when to stop taking GLYXAMBI if you are having surgery and when to start it again
• are eating less or there is a change in your diet
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking)
• have type 1 diabetes. GLYXAMBI should not be used to treat people with type 1 diabetes
• are pregnant or plan to become pregnant. GLYXAMBI may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with GLYXAMBI
• are breastfeeding or are planning to breastfeed. GLYXAMBI may pass into your breast milk and may harm your baby. Do not breastfeed while taking GLYXAMBI

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GLYXAMBI may affect the way other medicines work, and other medicines may affect how GLYXAMBI works.

*Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Glyxambi^® trademark under license.

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

For more information, please see Prescribing Information and Medication Guide.

CL-GLX-100084 10.17.2022