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FDA approves Brenzavvy for type 2 diabetes
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FDA approves Brenzavvy for type 2 diabetes

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New Drugs

Lauren Howell, PharmD

Close up photo of Brenzavvy pills.

In January of this year, FDA approved Brenzavvy (bexagliflozin—TheracosBio), a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). Brenzavvy is the fifth SGLT-2 inhibitor to become FDA approved.

Despite the efficacy of these medications, a study published in JAMA in 2021 found that 50% of patients taking SGLT-2 inhibitors stop therapy during the first year due to high cost and insurance barriers. The approval of new drugs in this promising class of medications brings hope that a more affordable option may be on the way for patients.

Recommended dosage and how it works

Brenzavvy reduces glucose levels in the blood by inhibiting the transporter that is mostly responsible for reabsorption of glucose in the renal proximal tubule.

When this transporter is inhibited, less glucose is reabsorbed into the bloodstream and more glucose is lost through urinary excretion. Brenzavvy is not indicated for use in patients with type 1 diabetes (T1D) as it may increase the risk of diabetic ketoacidosis in these patients.

The recommended dose is 20 mg once daily, taken in the morning with or without food. The tablet should not be crushed or chewed.

Renal function should be assessed prior to initiation of therapy. Volume depletion should be corrected before treatment begins.

In patients with an eGFR of <30 mL/min/1.73 m2, use of Brenzavvy is not recommended. A higher incidence of adverse reactions was seen in relation to reduced renal function.

Additionally, Brenzavvy is not recommended for patients with severe hepatic impairment. A higher incidence of adverse reactions specifically related to volume depletion is seen in older patients.

Patients of reproductive potential should be advised of the potential risk to a fetus, especially during the second and third trimesters, since Brenzavvy is not recommended during this time. Use of this therapy should also be avoided in breastfeeding patients.

Adverse effects

The most common adverse reactions seen in patients taking Brenzavvy are female genital mycotic infections, UTI, and increased urination. Patients who present with signs and symptoms of metabolic acidosis should be assessed for ketoacidosis, regardless of blood glucose level. If ketoacidosis is suspected, discontinue Brenzavvy, evaluate, and treat promptly. Patients should be monitored for signs and symptoms of infection or ulcers of the lower limbs, and Brenzavvy should be discontinued if these occur. Patients should be assessed for factors that may increase the risk of lower limb amputation before treatment with Brenzavvy begins. Monitor for signs and symptoms of volume depletion during therapy as this may result in acute kidney injury. Monitor for signs and symptoms of UTIs and treat promptly, if indicated, to avoid urosepsis and pyelonephritis.

When patients are being treated with insulin or an insulin secretagogue, a lower dose of these therapies should be considered to reduce the risk of hypoglycemia when used in combination with Brenzavvy. Serious, lifethreatening cases of necrotizing fasciitis of the perineum have occurred in both females and males treated with SGLT-2 inhibitors.

Assess patients presenting with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. Monitor and treat patients for genital mycotic infections as appropriate.

Clinical trials

Brenzavvy has been studied as a monotherapy and in combination with metformin in adults with T2D, in adults with T2D with moderate renal impairment, and in adults with T2D with established CVD or at increased risk for CVD. In these studies, treatment with Brenzavvy was found to reduce A1C compared to placebo and efficacy was noninferior to glimepiride 6 mg and sitagliptin 100 mg once daily. This A1C reduction was shown across subgroups of age, sex, race, and geographic region.

Patient counseling

Patients should be advised of the risk for ketoacidosis, lower limb amputation, volume depletion, serious UTIs, hypoglycemia with concomitant use of insulin and insulin secretagogues, necrotizing fasciitis of the perineum, and genital mycotic infections. Additionally, patients should be counseled on the signs and symptoms associated with each of the previously listed conditions.

Patients should be informed that their urine will test positive for glucose while taking Brenzavvy due to its mechanism of action.

Patients should be advised to take Brenzavvy exactly as prescribed. If a dose is missed, it should be taken as soon as possible but patients should not double their next dose. ■



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