MEDGUIDE SECTION

• Diabetic Ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis.Bexagliflozin tablets 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 bexagliflozin tablets 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.

      ○ nausea                              ○ tiredness

      ○ vomiting                           ○ trouble breathing

      ○ stomach-area (abdominal) pain         ○ ketones in your urine or blood

• Amputations. Bexagliflozin tablets 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 healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot.Talk to your healthcare provider about proper foot care.
• Dehydration. Bexagliflozin tablets can cause some people to become dehydrated (the loss of body water and salt). Dehydration can make you feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking bexagliflozin tablets.
  You may be at higher risk of dehydration if you:
  • take medicines that lower your blood pressure, including diuretics (water pills)
  • are on a low sodium (salt) diet
  • have kidney problems
  • are 65 years of age or older
  Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.Call 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 start to lose liquids from your body, for example from vomiting or diarrhea.
  You may also have a fever, back pain, nausea, or vomiting.
  
• Genital and urinary tract infections. Bexagliflozin tablets can cause serious infections in your genital area or urinary tract that could require hospitalization. A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This infection may require hospitalization, multiple surgeries, and could lead to death. Seek medical attention immediately if you have a fever 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:
  

  o pain or tenderness              o swelling                   o redness of skin (erythema)

  
  Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections:
  • Urinary tract infection:
    • burning feeling when you urinate
    • need to urinate often or right away
    • pain in the lower part of your stomach (pelvis)
    • blood in your urine
    You may also have a fever, back pain, nausea, or vomiting.
  • Vaginal yeast infection.
    • vaginal odor
    • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
    • vaginal itching
• Yeast infection of the skin around the penis (balanitis or balanoposthitis):  If you are uncircumcised, swelling may makes it difficult to pull back the skin around the tip of the penis. Other symptoms include:
  

  o redness, itching, or swelling of the penis   o rash of the penis

      o bad smelling discharge from the penis       o pain in the skin around the penis

• Bexagliflozin is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.
• Bexagliflozin is not recommended to decrease blood sugar in people with type 1 diabetes.
• It is not known if bexagliflozinis safe and effective in children under 18 years of age.

• are allergic to bexagliflozin or any of the ingredients in bexagliflozin tablets. See the end of this Medication Guide for a list of ingredients in bexagliflozin tablets. Symptoms of a serious allergic reaction to bexagliflozin tablets may include:
  o skin rash
  o raised red patches on your skin (hives)
  o swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

• 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
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• 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 bexagliflozin tabletsbefore you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking bexagliflozin tabletsand when to start it again.
• are eating less or there is a change in your diet
• are dehydrated
• drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• have ever had an allergic reaction to bexagliflozin tablets
• are pregnant or planning to become pregnant. Bexagliflozin may harm your unborn baby. If you become pregnant while taking bexagliflozin tablets, tell your healthcare provider as soon as possible. Talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. Bexagliflozin may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take bexagliflozin tablets. Do not breastfeed while taking bexagliflozin tablets.

• Take bexagliflozin tabletsexactly as your healthcare provider tells you to take it.
• Take bexagliflozin tabletsby mouth 1 time in the morning, with or without food.
• Do not crush or chew bexagliflozin tablets.
• Your healthcare provider may tell you to take bexagliflozin tabletsalong with other diabetes medicines. Low blood sugar can happen more often when bexagliflozin tablets are taken with certain other diabetes medicines. See “What are the possible side effects of bexagliflozin tablets?”
• If you miss a dose, take it as soon as you remember. If it is time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of bexagliflozin tabletsat the same time. Talk with your healthcare provider if you have questions about a missed dose.
• If you take too many bexagliflozin tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, fasting, binge drinking or surgery, the amount of diabetes medicine that you need may change. Tell your healthcare provider as soon as possible if you have any of these conditions and follow your healthcare provider’s instructions.
• Bexagliflozin tablets will cause your urine to test positive for glucose.
• Your healthcare provider may do certain blood tests before you start bexagliflozin tabletsand during treatment as needed. Your healthcare provider may change your dose of bexagliflozin tabletsbased on the results of your blood tests.

• See “What is the most important information I should know about bexagliflozin?”
• low blood sugar (hypoglycemia). If you take bexagliflozin tabletswith 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 bexagliflozin tablets. Signs or symptoms of low blood sugar may include:
  

  o headache     o drowsines      o sweating
  

  o confusion    o dizziness        o irritability
  

  o hunger         o fast heartbeat
  

  o shaking or feeling jittery      o weakness

• Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking bexagliflozin tabletsand call your healthcare provider right away or go to the nearest hospital emergency room. See “Do not take bexagliflozin tabletsif you:”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

• vaginal yeast infections
• urinary tract infections
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night.