Brenzavvy: Uses, Benefits, and Side Effects

For adults with type 2 diabetes in need of an affordable medication to lower blood sugar, Brenzavvy presents a promising option. Approved by the FDA in January 2023, Brenzavvy (bexagliflozin) has emerged as one of the most cost-effective SGLT-2 inhibitors available, priced at $50 or less per month. Initially accessible through online pharmacies like Cost Plus Drugs, Brenzavvy offers a more accessible treatment option. It is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

What is Brenzavvy?

Brenzavvy (bexagliflozin) is a prescription medicine taken once daily to help adults with type 2 diabetes improve glycemic (blood sugar) control in conjunction with diet and exercise. Brenzavvy functions as an SGLT2 inhibitor. This class of drugs works by causing excess sugar in the blood to be released from the body through the urine, thereby lowering the blood sugar level.

Understanding SGLT-2 Inhibitors

Brenzavvy belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works by helping the body remove excess glucose (sugar) through the urine. Brenzavvy was the fourth SGLT-2 inhibitor to gain approval, following Invokana (canagliflozin), Farxiga (dapagliflozin), Jardiance (empagliflozin), and Steglatro (ertugliflozin). Notably, it was also the first SGLT-2 inhibitor demonstrated to be effective in adults with type 2 diabetes and stage 3 chronic kidney disease.

Who Should Consider Brenzavvy?

The FDA approved Brenzavvy in conjunction with diet and exercise to lower blood sugar levels in adults with type 2 diabetes. The approval stemmed from 23 clinical trials involving over 5,000 adults with type 2 diabetes. These trials demonstrated the medication's effectiveness in lowering blood sugar levels and improving overall diabetes management. The medication can be used alone or in combination with other diabetes medications.

Limitations of Use

Brenzavvy is not indicated for use in people with type 1 diabetes. As with other SGLT-2 inhibitors, Brenzavvy is not indicated for use in people with type 1 due to the elevated risk of diabetic ketoacidosis (DKA).

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Health Benefits of Brenzavvy

Trials have demonstrated that Brenzavvy significantly lowers blood sugar levels and improves blood sugar management.

Impact on A1C Levels

The BEST trial, which examined Brenzavvy in adults with type 2 diabetes, found that, on average, participants' A1C levels decreased from 8.3% to 7.45%. A1C levels above 7% are associated with an increased risk of complications from diabetes, such as heart disease, kidney disease, and vision problems. A reduction of 0.85% in A1C levels can significantly reduce the risk of these complications.

Weight Loss

Researchers also found that participants taking Brenzavvy experienced roughly a 6-pound reduction in body weight after 48 weeks, and weight loss was sustained over time.

Cardiovascular Safety

Studies have also found that cardiovascular risks, such as stroke, heart attack, and heart-related death, are similar to those found in other approved SGLT-2 inhibitors.

Potential Side Effects of Brenzavvy

Brenzavvy (bexagliflozin) may cause some unwanted effects.

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Common Side Effects

Yeast infections are the most common side effect. Other common side effects of Brenzavvy are kidney or bladder infections and increased frequency or amount of pee.

Serious Side Effects

While less common, the most serious side effects of Brenzavvy are described below, along with what to do if they happen.

  • Severe Allergic Reactions: Brenzavvy may cause allergic reactions, which can be serious. Stop taking Brenzavvy and get help right away if you have any of the following symptoms of a serious allergic reaction: Breathing problems or wheezing, Racing heart, Fever or general ill feeling, Swollen lymph nodes, Swelling of the face, lips, mouth, tongue, or throat, Trouble swallowing or throat tightness, Itching, skin rash, or pale red bumps on the skin called hives, Nausea or vomiting, Dizziness, feeling lightheaded, or fainting, Stomach cramps, Joint pain.
  • Diabetic Ketoacidosis (DKA): Brenzavvy may cause diabetic ketoacidosis (a serious complication of diabetes). DKA can be life threatening. Stop taking Brenzavvy and get help right away if you have any of the following symptoms of diabetic ketoacidosis: Nausea/vomiting, Stomach pain, Feeling very tired, woozy, or confused, Difficulty breathing, Your breath smells fruity or sweet, Very high blood sugar levels (>300 mg/dL).
  • Dehydration: Brenzavvy may cause dehydration. Dehydration may lead to low blood pressure, especially when you stand up (orthostatic hypotension), or kidney damage. Call your healthcare provider right away if you have any of the following symptoms of dehydration, low blood pressure, or kidney damage: Dizziness or lightheadedness, Weakness or unusual tiredness, Confusion, Unsteadiness, Peeing less than normal, Swelling in your legs, ankles, and feet, Loss of appetite/nausea, Difficulty catching your breath or chest pain/pressure, Seizures, Extreme thirst.
  • Urosepsis and Pyelonephritis: Brenzavvy may cause pyelonephritis (a kidney infection) or urosepsis (an untreated urinary tract infection that spreads to your kidney). These are serious infections and may need to be treated in the hospital. Get help right away if you have any of the following symptoms of these serious infections: Dark, cloudy, or bloody pee or pee that smells bad, Fever and chills, Loss of appetite, Needing to pee a lot or feeling pain when you pee, Pain in your lower back, side, or groin, Upset stomach, nausea, and vomiting.
  • Low Blood Sugar (Hypoglycemia): Brenzavvy can cause low blood sugar, especially when combined with insulin or other medicines that increase your insulin levels. Low blood sugar can be serious and may lead to death. You may need a lower dose of your other diabetes medicine to reduce your risk of hypoglycemia. Do not take Brenzavvy and call your healthcare provider right away if you have any of the following symptoms of hypoglycemia: Headache, Crankiness or anxiety, Hunger, Dizziness or confusion, Blurry vision, Slurred speech, Sweating, Feeling jittery or shakiness, Fast heartbeat, Seizures.
  • Necrotizing Fasciitis (Fournier’s Gangrene): Brenzavvy can cause necrotizing fasciitis (an aggressive infection of the skin and the tissue underneath the skin that causes some of the tissue involved to die). Necrotizing fasciitis is rare, but very serious, can lead to death, and may require surgery to treat it. Get help right away if you have any of the following symptoms of this serious infection: Pain, redness, tenderness, or swelling of the perineum (of and around the anus and genitals), Fever, General feeling of illness or discomfort.
  • Amputations: People who take Brenzavvy may be more likely to have an amputation (limb or part of a limb cut off) than people who do not take Brenzavvy. The toe, part of the foot, or part of the leg were most often involved. Amputations seem more likely in people with diabetes, peripheral artery disease (narrowing of your blood vessels, often in your legs), diabetic foot infections, nerve damage in your legs, or who already had an amputation. Inspect your feet and legs regularly and contact your healthcare provider right away if you have sores, ulcers, or new pain or tenderness, as these may lead to the need for an amputation if not treated.

Other Side Effects to Monitor

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects. Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Drinking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination. Check with your doctor right away if you have bloody urine, decrease in how much or how often you urinate, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem. This medicine may increase your risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain. This medicine may increase your risk of having lower leg or toe amputation (leg removal surgery). Check with your doctor right away if you have pain, tenderness, sores or ulcers, or infections on your leg or foot. This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). Talk to your doctor about how to treat low blood sugar. Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions. This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. Check with your doctor right away if you have any of these symptoms. This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

Important Precautions

  • Pregnancy: Using this medicine during the second and later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
  • Surgery: Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine 3 days before you have surgery or other procedures that require fasting.
  • Other Medications: Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
  • Allergies: are allergic to bexagliflozin or any of the other ingredients.
  • Kidney Problems: Brenzavvy should not be used if your kidneys are not working as well as they should be.
  • Risk Factors for Diabetic Ketoacidosis: Tell your healthcare provider if you have any of the following risk factors for diabetic ketoacidosis: Type 1 diabetes or a history of diabetic ketoacidosis, Decrease in your insulin dose, Serious infection, Low-salt diet, Drink alcohol often or in large amounts, Pancreas problems, including a history of pancreatitis or surgery on your pancreas, Dehydration, Eating or drinking less than normal, Vomiting or diarrhea.
  • History of Genital Yeast Infections: Tell your healthcare provider if you have a history of genital (penis or vagina) yeast infections.
  • Risk Factors for an Amputation: Tell your healthcare provider if you have any of the following risk factors for an amputation: History of an amputation, Heart disease or are at high risk for heart disease, Blood flow problems, especially in your legs, Nerve problems in your legs, History of a diabetic foot ulcers or sores.
  • Other Current and Past Health Conditions: Tell your healthcare provider if you have any of the following: Kidney problems, Liver problems, History of kidney or bladder infections or difficulty peeing, Have surgery or a procedure scheduled.

Dosage and Administration

Brenzavvy (bexagliflozin) is a tablet that contains 20 mg of bexagliflozin and is recommended to be taken once daily, in the morning (or at the beginning of the day if that is not in the morning) with or without food. If you are scheduled for a major surgery or procedure that requires fasting, do not take Brenzavvy for at least 3 days prior to the surgery, if possible. Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Do not crush or chew the tablet. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Swallow whole.

Potential Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. Beta blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are not affected by these drugs. Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar.

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Brenzavvy may interact with other medicines and supplements. Before taking Brenzavvy, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using any of the following before taking Brenzavvy: Lithium, which is a medicine for certain mental health conditions, A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure, Other medicines for diabetes. Some other medicines may alter the blood levels of Brenzavvy.

Storage Information

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Brenzavvy oral tablets should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

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