Brenzavvy is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

Brenzavvy belongs to the class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works by reducing renal reabsorption of filtered glucose and lowering the renal threshold for glucose, thereby increasing urinary glucose excretion.

What is Brenzavvy used to treat?

Brenzavvy is used to treat type 2 diabetes.

Type 2 diabetes is a chronic disease characterized by high levels of sugar in the blood. It occurs when the body's cells resist the normal effect of insulin (a hormone produced by the pancreas), which is to drive glucose in the blood into the inside of the cells.

In people with insulin resistance, the pancreas responds to rising blood glucose levels by making extra insulin to maintain normal blood sugar levels. As the pancreas makes more and more insulin over time, it eventually cannot meet the demand, and blood glucose levels become elevated.

Brenzavvy works treat type 2 diabetes by lowering blood glucose levels.

Brenzavvy is not for people with type 1 diabetes. It may increase the risk of diabetic ketoacidosis in these people.

It is not known if Brenzavvy is safe and effective in children under 18 years of age.

Brenzavvy can cause serious side effects, including:

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people with type 1 diabetes treated with medicines like Brenzavvy or in people with type 2 diabetes during treatment with Brenzavvy. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with medicines like Brenzavvy. Ketoacidosis is a serious condition, which needs to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with Brenzavvy even if your blood sugar is less than 250 mg/dL. Stop taking treatment and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following symptoms:
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing

If you get any of these symptoms during treatment, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.

• Amputations. Brenzavvy may increase your risk of lower limb amputations. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation.
  You may be at a higher risk of lower limb amputation if you:
  • have a history of amputation
  • have heart disease or are at risk for heart disease
  • 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. Your healthcare provider may decide to stop your treatment for a while if you have these signs or symptoms. Talk to your healthcare provider about proper foot care.

• Dehydration. Brenzavvy 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 Brenzavvy.
  You may be at higher risk of dehydration if you:
  • have low blood pressure
  • 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.
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 start to lose liquids from your body, for example from vomiting or diarrhea.

• Vaginal yeast infection. Women who take Brenzavvy may get vaginal yeast infections. Yeast infections can be a serious but common side effect of taking Brenzavvy. Symptoms of a vaginal yeast infection include:
  • vaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
• Yeast infection of the penis (balanitis or balanoposthitis). Men who take Brenzavvy may get a yeast infection of the skin around the 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 the penis. Other symptoms of yeast infection of the penis include:
  • redness, itching, or swelling of the penis
  • rash of the penis
  • foul smelling discharge from the penis
  • pain in the skin around penis

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis.
Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider as soon as possible if you use an over-the counter antifungal medication and your symptoms do not go away.

• Take Brenzavvy tablets exactly as your healthcare provider tells you.
• Take the tablets by mouth 1 time in the morning, with or without food.
• Do not crush or chew the tablets.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses at the same time. Talk with your healthcare provider if you have questions about a missed dose.
• Your healthcare provider may tell you to take Brenzavvy along with other diabetes medicines. Low blood sugar can happen more often when Brenzavvy is taken with certain other diabetes medicines. See Brenzavvy side effects.
• If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room as soon as possible.
• 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.
• Check your blood sugar as your healthcare provider tells you to.
• Stay on your prescribed diet and exercise program during treatment.
• Talk to your healthcare provider about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
• Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1c (HbA1c).
• When taking Brenzavvy, you will have sugar in your urine, which will show up on a urine test.

Usual Adult Dose for Type 2 Diabetes

20 mg once daily, taken in the morning.

Use: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

You should not take Brenzavvy if you:

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

Before you take Brenzavvy

Before you take Brenzavvy, tell your healthcare provider about all of your medical conditions, including if you:

• have type 1 diabetes or have had diabetic ketoacidosis
• have kidney problems.
• have liver problems.
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
• have had frequent urinary tract infections or problems with urination.
• are eating less or there is a change in your diet.
• are going to have surgery. Your healthcare provider may stop your Brenzavvy before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop treatment and when to start it again.
• drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• have had foot ulcers, reduction or loss of feeling in a foot, bad circulation in the legs or feet, or amputations.
• are pregnant or planning to become pregnant. Brenzavvy may harm your unborn baby. If you become pregnant while taking Brenzavvy, 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. Brenzavvy 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 Brenzavvy. Do not breastfeed while taking Brenzavvy.

Brenzavvy may cause serious side effects, including:

• See Important information.
• serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking Brenzavvy. Tell your healthcare provider if you have 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 also may have a fever, back pain, nausea or vomiting.
• low blood sugar (hypoglycemia). If you take Brenzavvy 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 Brenzavvy. Signs or symptoms of low blood sugar may include:
  • headache
  • drowsiness
  • hunger
  • irritability
  • dizziness
  • confusion
  • sweating
  • feeling jittery or shaky
  • weakness
  • fast heartbeat
• 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 people who take Brenzavvy. 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 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:
  • pain or tenderness
  • swelling
  • redness of the skin (erythema)

The most common side effects include:

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

These are not all the possible side effect. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Brenzavvy may affect the way other medicines work, and other medicines may affect how Brenzavvy works.