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What is GLYXAMBI?

GLYXAMBI is a prescription medication containing two medicines, empagliflozin (JARDIANCE) and linagliptin (TRADJENTA). GLYXAMBI can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and can be used in adults with type 2 diabetes who have known cardiovascular disease when empagliflozin, one of the medicines in GLYXAMBI, is needed to reduce the risk of cardiovascular death.

GLYXAMBI is not for people with type 1 diabetes or for diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas) it is not known if you have a higher chance of getting pancreatitis while taking GLYXAMBI.

IMPORTANT SAFETY INFORMATION

Do not take GLYXAMBI if you have severe kidney problems, end stage renal disease, or 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 doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.Stop taking GLYXAMBI and call your doctor 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.
  • Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking GLYXAMBI, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor 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.
  • 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. You may be at higher risk of dehydration if you have low blood pressure, 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 doctor about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis.
  • 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 doctor 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
  • Kidney problems. Sudden kidney injury has happened to people taking GLYXAMBI. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, 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 doctor 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 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. Women who take GLYXAMBI may get vaginal yeast infections. Talk to your doctor if you experience 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. Men who take GLYXAMBI may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience 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, 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 doctor 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 doctor 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 doctor right away if you develop blisters.

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 doctor or pharmacist.

Before taking GLYXAMBI, tell your doctor 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 doctor may stop your GLYXAMBI before you have surgery. Talk to your doctor if you are having surgery about when to stop taking GLYXAMBI 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 doctor 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 doctor 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.

Especially tell your doctor if you take:

  • insulin or other medicines that can lower your blood sugar
  • diuretics (water pills)
  • rifampin (Rifadin, Rimactane, Rifater, Rifamate),* an antibiotic that is used to treat tuberculosis
  • *Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Glyxambi® trademark under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.

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-100054 03.30.2020

What is GLYXAMBI?

GLYXAMBI is a prescription medication containing two medicines, empagliflozin (JARDIANCE) and linagliptin (TRADJENTA). GLYXAMBI can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and can be used in adults with type 2 diabetes who have known cardiovascular disease when empagliflozin, one of the medicines in GLYXAMBI, is needed to reduce the risk of cardiovascular death.

GLYXAMBI is not for people with type 1 diabetes or for diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas) it is not known if you have a higher chance of getting pancreatitis while taking GLYXAMBI.

IMPORTANT SAFETY INFORMATION

Do not take GLYXAMBI if you have severe kidney problems, end stage renal disease, or 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 doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.Stop taking GLYXAMBI and call your doctor 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.
  • Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking GLYXAMBI, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor 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.
  • 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. You may be at higher risk of dehydration if you have low blood pressure, 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 doctor about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis.
  • 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 doctor 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
  • Kidney problems. Sudden kidney injury has happened to people taking GLYXAMBI. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, 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 doctor 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 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. Women who take GLYXAMBI may get vaginal yeast infections. Talk to your doctor if you experience 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. Men who take GLYXAMBI may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience 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, 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 doctor 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 doctor 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 doctor right away if you develop blisters.

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 doctor or pharmacist.

Before taking GLYXAMBI, tell your doctor 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 doctor may stop your GLYXAMBI before you have surgery. Talk to your doctor if you are having surgery about when to stop taking GLYXAMBI 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 doctor 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 doctor 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.

Especially tell your doctor if you take:

  • insulin or other medicines that can lower your blood sugar
  • diuretics (water pills)
  • rifampin (Rifadin, Rimactane, Rifater, Rifamate),* an antibiotic that is used to treat tuberculosis
  • *Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Glyxambi® trademark under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.

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-100054 03.30.2020

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