Brenzavvy

— THERAPEUTIC CATEGORIES —
  • Diabetes
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Brenzavvy Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Bexagliflozin 20mg; tabs.

    Pharmacological Class

    Sodium-glucose co-transporter 2 (SGLT2) inhibitor.

    How Supplied

    Tabs—30, 90

    Storage

    Store from 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]

    Manufacturer

    TheracosBio, LLC

    Generic Availability

    NO

    Mechanism of Action

    Bexagliflozin is an inhibitor of sodium-glucose co-transporter 2 (SGLT2). By inhibiting SGLT2, bexagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. 

    Brenzavvy Indications

    Indications

    Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). 

    Limitations of Use

    Not recommended in patients with type 1 diabetes.

    Brenzavvy Dosage and Administration

    Adult

    eGFR <30mL/min/1.73m2: not recommended. Swallow whole. eGFR ≥30mL/min/1.73m2:  20mg once daily in the AM. 

    Children

    <18yrs: not established.

    Brenzavvy Contraindications

    Not Applicable

    Brenzavvy Boxed Warnings

    Not Applicable

    Brenzavvy Warnings/Precautions

    Warnings/Precautions

    Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected; evaluate and treat if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold (at least 3 days), if possible, prior to major surgery or procedures associated with prolonged fasting. Increased risk of lower limb amputations. Consider risk factors for amputation prior to initiation (eg, history of amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Monitor for infection, new pain or tenderness, sores or ulcers in lower limbs; discontinue if occur. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs; monitor and treat appropriately. Renal impairment. Severe hepatic impairment: not recommended. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

    Brenzavvy Pharmacokinetics

    Absorption

    Peak plasma concentrations were reached between 2–4 hours post-dose.

    Distribution

    Apparent volume of distribution: 262 L. Plasma protein bound: ~93%.

    Metabolism

    Hepatic (primarily UGT1A9). 

    Elimination

    Fecal (28.7%), renal (1.5%). Half-life: ~12 hours.

    Brenzavvy Interactions

    Interactions

    May be antagonized by UGT inducers: consider additional antihyperglycemic for glycemic control. Consider a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

    Brenzavvy Adverse Reactions

    Adverse Reactions

    Female genital mycotic infections, UTIs (may be serious), increased urination; hypotension, ketoacidosis (may be fatal), acute kidney injury, hypoglycemia, urosepsis, pyelonephritis; rare: Fournier's gangrene.

    Brenzavvy Clinical Trials

    Clinical Trials

    The efficacy and safety of bexagliflozin was evaluated as monotherapy (ClinicalTrials.gov Identifier: NCT02715258), in combination with metformin (ClinicalTrials.gov Identifier: NCT03259789), and vs glimepiride (ClinicalTrials.gov Identifier: NCT02769481) and sitagliptin (ClinicaTrials.gov Identifier: NCT03115112) as add-on therapy to metformin. Bexagliflozin was also studied in adults with type 2 diabetes mellitus with moderate renal impairment (ClinicalTrials.gov Identifier: NCT02836873), and in adults with type 2 diabetes mellitus with established cardiovascular disease (CVD) or at increased risk for CVD (ClinicalTrials.gov Identifier: NCT02558296).

    Findings from these studies showed that treatment with bexagliflozin significantly reduced hemoglobin A1c compared with placebo. The efficacy of bexagliflozin was observed to be noninferior to glimepiride (titrated to a maximum dose of 6mg) and sitagliptin 100mg once daily.

    Bexagliflozin was not found to be superior to placebo in reducing MACE (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina). In a trial that included patients with type 2 diabetes and either established CVD or multiple risk factors for CVD, 10.1% (57/567) of the placebo group experienced 1 MACE event vs 7.9% (89/1132) of the bexagliflozin group.

    Brenzavvy Note

    Not Applicable

    Brenzavvy Patient Counseling

    See Literature

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