Brenzavvy

Brenzavvy is used to improve blood sugar (glucose) control in adults with type 2 diabetes, alongside diet and exercise. Type 2 diabetes is a chronic disease characterized by high levels of sugar in the blood.

Brenzavvy (bexagliflozin) belongs to the class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works by helping the kidneys filter out excess glucose and pass it out of the body in the urine, rather than reabsorbing it back into the blood.

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

Brenzavvy (bexagliflozin) received FDA approval on January 20, 2023. There is no generic.

• 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.
• 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.
• If you miss a dose, take it as soon as you remember. If it is almost 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.
• If you take too much Brenzavvy, 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 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.
• Brenzavvy will cause your urine to test positive for glucose.
• Your healthcare provider may do certain blood tests before you start Brenzavvy and during treatment as needed. Your healthcare provider may change your dose of Brenzavvy based on the results of your blood tests.

Brenzavvy can cause serious side effects, including:

• Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. Brenzavvy can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition that 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 Brenzavvy and call your healthcare provider or get medical help right away if you get any of the following: nausea, tiredness, vomiting, trouble breathing, stomach-area (abdominal) pain, ketones in your urine or blood. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL

• Amputations. Brenzavvy 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, or 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. 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:

• 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 daily. 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.

• Genital and urinary tract infections. Brenzavvy 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: pain or tenderness swelling 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 (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 make it difficult to pull back the skin around the tip of your penis. Other symptoms include redness, itching, or swelling of the penis, rash on the penis, bad-smelling discharge from the penis, and pain in the skin around the penis.

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection. They may suggest you use an over-the-counter antifungal medicine. Contact your healthcare provider right away if your symptoms do not improve after using an over-the-counter antifungal medicine.

Do not take Brenzavvy if you are allergic to bexagliflozin or any of the other ingredients in Brenzavvy. See the end of this page for a list of ingredients. Symptoms of a serious allergic reaction may include a 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.

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

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 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 Brenzavvy before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking Brenzavvy and 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 Brenzavvy
• 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.

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. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Serious side effects

Brenzavvy may cause the following serious side effects. Also see "What is the most important information I should know about Brenzavvy?":

• 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, sweating, confusion, dizziness, irritability, hunger, fast heartbeat, shaking or feeling jittery, or weakness.
• Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking Brenzavvy and call your healthcare provider right away or go to the nearest hospital emergency room. See "Do not take Brenzavvy if you:". Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

Common side effects

The most common side effects of Brenzavvy are:

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

These are not all the possible side effects of Brenzavvy. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Brenzavvy for type 2 diabetes

• 20 mg orally once daily, taken in the morning, with or without food.
• Do not crush or chew the tablet.

Before starting and during treatment:

• Your healthcare provider will check your kidney function before you start Brenzavvy and from time to time during treatment.
• Brenzavvy is not recommended if your eGFR is less than 30 mL/min/1.73 m2.
• Your healthcare provider will check that you are not dehydrated (volume depleted) and will correct this before you start Brenzavvy.
• Brenzavvy should be stopped for at least 3 days, if possible, before surgery or any procedure that involves prolonged fasting, and restarted once you are stable and eating and drinking normally.

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.

Medicines that may interact with Brenzavvy include:

• insulin or an insulin secretagogue (such as a sulfonylurea), which can increase your risk of low blood sugar. Your healthcare provider may lower the dose of your insulin or sulfonylurea.
• lithium. Brenzavvy may lower the level of lithium in your blood, so your healthcare provider may check your lithium level more often when you start or stop Brenzavvy.
• certain medicines that speed up how the body clears Brenzavvy (UGT enzyme inducers), which may make Brenzavvy less effective. Your healthcare provider may add another diabetes medicine if you need more blood sugar control.

Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Store Brenzavvy at room temperature between 68°F and 77°F (20°C and 25°C).

Brief excursions are permitted between 59°F and 86°F (15°C and 30°C).

Keep out of the reach of children.

Active ingredient: bexagliflozin

Inactive ingredients: colloidal silicon dioxide, glyceryl dibehenate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene oxide, and poloxamer 188.

In addition, the film coating ingredient, Opadry II Blue 85F99153, contains the inactive ingredients FD&C Blue #1/Brilliant Blue FCF and FD&C Blue #2/Indigo Carmine, macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide.

Brenzavvy (bexagliflozin) is distributed by TheracosBio, LLC, 945 Concord Street, Framingham, MA 01701. Brenzavvy is a registered trademark of TheracosBio, LLC.