Bexagliflozin

What is Bexagliflozin?

• Bexagliflozin (Brenzavvy) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Bexagliflozin

What are the uses of this medicine?

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

limitations of use:

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

How does this medicine work?

• Bexagliflozin is an inhibitor of sodium-glucose co-transporter 2 (SGLT2), the transporter responsible for reabsorption of the majority of glucose from the renal glomerular filtrate in the renal proximal tubule. By inhibiting SGLT2, bexagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to bexagliflozin or any of the ingredients in Brenzavvy.
• are on kidney dialysis.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Be sure to mention any of the following:

• Insulin and Insulin Secretagogues
• Lithium
• UGT Enzyme Inducers

Is this medicine FDA approved?

• It was approved for medical use in the United States in December 2022.

How should this medicine be used?

• Assess renal function prior to initiation of Brenzavvy and periodically thereafter as clinically indicated.
• Correct volume depletion before initiating.
• Not recommended if eGFR less than 30 mL/min/1.73 m2.

Recommended dosage: The recommended dosage of Brenzavvy is 20 mg orally taken once daily in the morning, with or without food.

Administration:

• Take Brenzavvy by mouth 1 time in the morning, with or without food.
• Do not crush or chew Brenzavvy 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 of Brenzavvy 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.
• Check your blood sugar as your healthcare provider tells you to.
• Stay on your prescribed diet and exercise program while taking Brenzavvy.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 20 mg

This medicine is available in fallowing brand namesː

• Brenzavvy

What side effects can this medication cause?

The most common side effects of this medicine in Adult Patients include:

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

Less common, but serious side effects may include:

• Ketoacidosis
• Amputations
• Dehydration
• Vaginal yeast infection
• balanitis or balanoposthitis

What special precautions should I follow?

• Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have been identified. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, evaluate, and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
• An increased incidence of lower limb amputations occurred in Brenzavvy-treated patients. Consider factors that may increase the risk for amputations before initiating Brenzavvy. Monitor patients for signs and symptoms of infection, or ulcers of the lower limbs, and discontinue if these occur.
• Brenzavvy can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. Before initiating Brenzavvy, assess and correct volume status in patients with impaired renal function or low systolic blood pressure, elderly patients or patients on diuretics. Monitor for signs and symptoms during therapy.
• There have been reports of serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving SGLT2 inhibitors, including Brenzavvy. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
• Insulin and insulin secretagogues (e.g., sulfonylureas) are known to cause hypoglycemia. Brenzavvy may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination with Brenzavvy.
• Necrotizing fasciitis of the perineum (Fournier’s Gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Serious, life-threatening cases have occurred in both females and males treated with SGLT2 inhibitors. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
• Brenzavvy increases the risk of genital mycotic infections. Monitor and treat as appropriate.
• Advise pregnant patients and females of reproductive potential of the potential risk to a fetus with treatment with Brenzavvy. Instruct patients to inform their healthcare provider if pregnant or planning to become pregnant.
• Advise patients that breastfeeding is not recommended during treatment with Brenzavvy.
• Inform patients that their urine will test positive for glucose while taking Brenzavvy due to its mechanism of action.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Employ the usual supportive measures as dictated by the patient’s clinical status.
• Removal of bexagliflozin by hemodialysis has not been studied.

Can this medicine be used in pregnancy?

• Brenzavvy is not recommended during the second and third trimesters of pregnancy.
• 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.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

Distributed by:

• TheracosBio, LLC
• 225 Cedar Hill Street, Suite 200
• Marlborough, MA USA

• Brenzavvy is a trademark of TheracosBio, LLC

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Bexagliflozin
• FDA Bexagliflozin

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