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.

Symptoms of a serious allergic reaction may include:

• skin rash, itching, flaking or peeling

• raised red patches on your skin (hives)

• swelling of your face, lips, tongue and throat that may cause difficulty in breathing or swallowing

• difficulty with swallowing or breathing

If you have any of these symptoms, stop taking GLYXAMBI and call your healthcare provider right away or go to the nearest hospital emergency room.

GLYXAMBI can cause serious side effects, including:

• Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. Empagliflozin, a component of GLYXAMBI, can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, and are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking GLYXAMBI and call your healthcare provider or get medical help right away if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:     

  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing
  • ketones in your urine or blood

• 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.

• 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.

  • take medicines to lower blood pressure, including diuretics (water pills)
  • are on a low sodium (salt) diet
  • have kidney problems
  • 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.

• 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.
• 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 people 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).
• Amputations. SGLT2 inhibitors may increase your risk of lower limb amputations. You may be at a higher risk of lower limb amputation if you have a history of amputation; have had blocked or narrowed blood vessels, usually in your leg; have had diabetic foot infection, ulcers or sores. Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.
• Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking GLYXAMBI and call your healthcare provider right away or go to the emergency room.
• Joint pain. Some people who take linagliptin, 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 type 1 diabetes or have had diabetic ketoacidosis
• have a decrease in your insulin dose
• have a serious infection
• have a history of infection of the vagina or penis
• have a history of amputation
• have kidney problems
• have liver problems
• have a history of urinary tract infections or problems with urination
• are on a low sodium (salt) diet. Your healthcare provider may change your diet or your dose
• 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
• are dehydrated
• 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 ever had an allergic reaction to GLYXAMBI
• 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-100102 10.30.2023