Do not take STEGLUJAN if you:
- have severe kidney problems, end stage renal disease (ESRD), or are on dialysis.
- are allergic to ertugliflozin (STEGLATRO®), sitagliptin (JANUVIA®), 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:
- Inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before taking STEGLUJAN, tell your doctor if you have ever had pancreatitis, a history of alcoholism, kidney problems, stones in your gallbladder (gallstones), high blood triglyceride levels. 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.
- Ketoacidosis (increased ketones in your blood or urine) has happened in people with type 1 diabetes or 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 need to be treated in a hospital and may lead to death. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Stop taking STEGLUJAN and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area (abdominal) pain, tiredness, trouble breathing. If possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
- Amputations. STEGLUJAN 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 damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores. 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.
- Dehydration. STEGLUJAN can cause some people to become dehydrated (loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking STEGLUJAN. You may be at 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. Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.
- 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; foul smelling discharge from the penis; rash of the penis; or pain in the skin around your penis. Certain 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. Heart failure means your heart does not pump blood well enough. Before you start taking STEGLUJAN, 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 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.
- 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 being in the sun too long.
- Serious urinary tract infections (UTI), that may lead to hospitalization can occur. Tell your doctor if you have any symptoms of a UTI, such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people may also have a fever, back pain, nausea, or vomiting.
- Low blood sugar (hypoglycemia) can occur if you take STEGLUJAN with another medicine that can cause low blood sugar, such as a sulfonylurea 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 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, and may lead to hospitalization, multiple surgeries, and death. Seek immediate medical attention if you have fever above 100.4°F or feel very weak, tired, or uncomfortable and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, or redness of skin.
- Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking STEGLUJAN and call your doctor right away. Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
- 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 treatment in a hospital. Tell your doctor right away 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 yeast infections of the vagina or penis and changes in urination, including an urgent need to urinate more often, in larger amounts, or at night.
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.
You are encouraged to report side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the accompanying Medication Guide for STEGLUJAN and discuss it with your health care team. The physician Prescribing Information also is available.
