• Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. STEGLUJAN 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, 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 STEGLUJAN and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:

• Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
  Before you start taking STEGLUJAN, tell your healthcare provider if you have ever had:

• 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

• Dehydration. STEGLUJAN can cause some people to become dehydrated (the 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.

• take medicines to lower your blood pressure, including water pills (diuretics)
• are on a low sodium (salt) diet
• have kidney problems
• are 65 years of age or older

• Vaginal yeast infection. Symptoms of a vaginal yeast infection include:

• Yeast infection of the penis (balanitis or balanoposthitis). Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:

• Heart failure. Heart failure means your heart does not pump blood well enough.
  Before you start taking STEGLUJAN, 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
  • unusual tiredness

These may be symptoms of heart failure.

• 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 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.
• 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 STEGLUJAN before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking STEGLUJAN 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 STEGLUJAN.
• are pregnant or plan to become pregnant. STEGLUJAN may harm your unborn baby. If you become pregnant while taking STEGLUJAN, your healthcare provider may switch you to a different medicine to control your blood sugar. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if STEGLUJAN passes into your breast milk. You should not breastfeed if you take STEGLUJAN.

• Kidney problems (sometimes requiring dialysis). Sudden kidney injury has happened to people treated with STEGLUJAN. Talk to your healthcare provider right away if you:
  • reduce the amount of food or liquid you drink, for example, if you are sick or cannot eat or
  • you start to lose liquids from your body, for example, from vomiting, diarrhea or being in the sun too long

• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking STEGLUJAN. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection 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). If you take STEGLUJAN 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 while you take STEGLUJAN. Signs and symptoms of low blood sugar may include:

• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take medicines that lower blood sugar in the same way as one of the medicines in STEGLUJAN. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever above 100.4°F or you 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:

• Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking STEGLUJAN and call your healthcare provider right away or go to the nearest hospital emergency room. See “Who should not take STEGLUJAN?”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
• Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in STEGLUJAN, may develop joint pain that can be severe. Call your healthcare provider 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 healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking STEGLUJAN.

• vaginal yeast infections and yeast infections of the penis (See "What is the most important information I should know about STEGLUJAN?")
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

• upper respiratory infection
• stuffy or runny nose and sore throat
• headache
• stomach upset and diarrhea

• Store STEGLUJAN at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep STEGLUJAN dry.