Brenzavvy

— THERAPEUTIC CATEGORIES —
  • Diabetes

Brenzavvy Generic Name & Formulations

General Description

Bexagliflozin 20mg; tabs.

Pharmacological Class

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

How Supplied

Tabs—30, 90

Manufacturer

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; may increase risk of diabetic ketoacidosis. 

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

Contraindications

Patients on dialysis.

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; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). 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

Plasma protein bound: ~93%.

Apparent volume of distribution: 262 L.

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

See Literature

Brenzavvy Note

Not Applicable

Brenzavvy Patient Counseling

See Literature

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