IMPORTANT SAFETY INFORMATION
What is the most important information I should know about GLYXAMBI?
- Serious side effects can happen to people taking GLYXAMBI, 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 have dehydration (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.
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition, which may need 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. Stop taking GLYXAMBI and call your doctor right away if you get any of the following symptoms and, if possible, check for ketones in your urine:
- stomach-area (abdominal) pain
- trouble breathing
- 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.
- 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.
Who should not take GLYXAMBI?
Do not take GLYXAMBI if you have severe kidney problems or 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 to GLYXAMBI may include skin rash, itching, flaking or peeling; raised red patches on your skin (hives); difficulty swallowing or breathing; or swelling of your face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any of these symptoms, stop taking GLYXAMBI and call your doctor or go to the emergency room right away.
What should I tell my doctor before using GLYXAMBI?
Tell your doctor if you:
- have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with GLYXAMBI
- 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
- are eating less due to illness, surgery, or 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 any other medical conditions
- 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 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
- *These trademarks are owned by third parties not affiliated with GLYXAMBI.
What are the possible side effects of GLYXAMBI?
GLYXAMBI may cause serious side effects, including:
- 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.
- Allergic (hypersensitivity) reactions can happen after your first dose or up to 3 months after starting GLYXAMBI. Symptoms 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); and/or skin rash, itching, flaking, or peeling. If you have any of these symptoms, stop taking GLYXAMBI and call your doctor or go to the emergency room right away.
- 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.
- Increased fats in your blood (cholesterol)
- 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.
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.