BRENZAVVY

The pharmacokinetics of bexagliflozin are similar in healthy subjects and adults with type 2 diabetes mellitus. Following dosing in the fasted state, mean C max and AUC 0-∞ were 134 ng/mL and 1,162 ng·h/mL, respectively. Bexagliflozin does not exhibit time-dependent pharmacokinetics and accumulates in plasma up to ~20% following multiple dosing.

AbsorptionFollowing oral administration of BRENZAVVY, peak plasma concentrations of bexagliflozin were reached between 2 – 4 hours post-dose and can be...

14.1 Overview of Clinical Trials BRENZAVVY has been studied as monotherapy (Trial 1) and in combination with metformin in adults with type 2 diabetes mellitus (Trials 2, 3, and 4) [see Clinical Studies ( 14.2 and 14.3 )] . BRENZAVVY has also been studied in adults with type 2 diabetes mellitus with moderate renal impairment (Trial 5) [see Clinical Studies ( 14.4 )] , and in adults with type 2 diabetes mellitus with established CVD or at increased risk for CVD (Trial 6) [see Clinical Studies ( 14.5 )] . Treatment with BRENZAVVY reduced hemoglobin A1c (HbA1c) compared to placebo and efficacy was...

The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions ( 5.1 )] Lower Limb Amputation [see Warnings and Precautions ( 5.2 ) ] Volume Depletion [see Warnings and Precautions ( 5.3 )] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see War...

BRENZAVVY is contraindicated in patients: With hypersensitivity to bexagliflozin or any excipient in BRENZAVVY. Anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (SGLT2) inhibitors.

• Hypersensitivity to bexagliflozin or any excipient in BRENZAVVY

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue BRENZAVVY if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. ( 5.1 ) Lower limb amputation: Consider factors that may increase the risk for amputations before initiating BRENZAVVY. Monitor patients for...

7 DRUG INTERACTIONS See Table 4 for clinically significant interactions with BRENZAVVY. Table 4. Clinically Significant Interactions with BRENZAVVY UGT Enzyme Inducers Clinical Impact UGT Enzyme Inducers may significantly reduce exposure to BRENZAVVY and lead to a decreased efficacy [see Clinical Pharmacology ( 12.3 )]. Intervention Consider adding another antihyperglycemic agent in patients who ...