Do not take STEGLUJAN™ (ertugliflozin and sitagliptin) if you have severe kidney problems or are on dialysis. Do not take STEGLUJAN if you are allergic to sitagliptin (JANUVIA®), ertugliflozin (STEGLATRO™), or any of the ingredients in STEGLUJAN. Symptoms of a serious allergic reaction to STEGLUJAN may include skin rash, raised red patches on the skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
STEGLUJAN may cause serious side effects including:
- Pancreatitis (inflammation of the pancreas), which may be severe and lead to death. Before taking STEGLUJAN, tell your doctor if you have ever had pancreatitis. Stop taking STEGLUJAN 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 through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
- Dehydration (loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). 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); have kidney problems; are on a low-salt diet; or are 65 years of age or older.
- Vaginal yeast infection. Talk to your doctor if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.
- Yeast infection of the penis (balanitis or balanoposthitis). Talk to your doctor if you have redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around your penis. Men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of your penis.
- Heart Failure. Tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have symptoms of heart failure: 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.
- Ketoacidosis (increased ketones in the blood or urine) has happened in people with type 1 and type 2 diabetes during treatment and also in people with diabetes who were sick or who had surgery during treatment with STEGLUJAN. Ketoacidosis is a serious condition, which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal (stomach area) pain. If you get any of these symptoms, stop taking STEGLUJAN and call your doctor. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.
- Kidney problems. Talk to your doctor right away if you reduce the amount you eat or drink (for example, if you are sick or cannot eat), or if you lose liquids from vomiting, diarrhea, or excessive heat exposure.
- Serious urinary tract infections (UTI), some that lead to hospitalization. Tell your doctor if you have any symptoms of a UTI, including a burning feeling when passing urine, a need to urinate often, an urgent need to urinate, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea, or vomiting.
- Amputations. STEGLUJAN may increase your risk of lower limb amputations. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your STEGLUJAN if you have any of these signs or symptoms. Talk to your doctor about proper foot care. You may be at a higher risk of lower limb amputation if you have or have had: a history of amputation; blocked or narrowed blood vessels; damage to the nerves (neuropathy) in your leg; and/or diabetic foot ulcers or sores.
- Low blood sugar (hypoglycemia) can occur if you take STEGLUJAN with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms include headache, drowsiness, hunger, irritability, dizziness, confusion, sweating, feeling jittery or shaky, weakness, and/or fast heartbeat. Follow your doctor’s instructions for treating low blood sugar.
- Necrotizing fasciitis, a rare but serious bacterial infection of the tissue under the skin in the area between and around the anus and genitals (perineum), has happened in women and men who take medicines that lower blood sugar in the same way as STEGLUJAN, which may lead to hospitalization, multiple surgeries, and death. Seek immediate medical attention if you have fever or feel very weak, tired, or uncomfortable and you develop: pain or tenderness, swelling, or redness of skin in the perineum.
- Increased fats in your blood (bad cholesterol or LDL).
- Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking STEGLUJAN and call your doctor right away.
- Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in STEGLUJAN, may develop severe joint pain. Call your doctor if you have severe joint pain.
- Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in STEGLUJAN, may develop a skin reaction called bullous pemphigoid that can require hospitalization. Tell your doctor if you develop blisters or the breakdown of the outer layer of your skin. Your doctor may tell you to stop taking STEGLUJAN.
The most common side effects of ertugliflozin include genital yeast infections and changes in urination.
The most common side effects of sitagliptin include upper respiratory tract infection, stuffy or runny nose and sore throat, headache, and stomach upset and diarrhea.
STEGLUJAN is a prescription medicine that contains sitagliptin (JANUVIA®) and ertugliflozin (STEGLATRO™). STEGLUJAN is used with diet and exercise to help lower blood sugar levels in adults with type 2 diabetes.
STEGLUJAN is not for type 1 diabetes and/or 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 it while taking STEGLUJAN.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.