BRENZAVVY Tablet Ref.[107226] Active ingredients: Bexagliflozin

2.1 Testing Prior to Initiation and During Treatment with BRENZAVVY

• Assess renal function prior to initiation of BRENZAVVY and periodically thereafter as clinically indicated [see Warnings and Precautions (5.3)]. BRENZAVVY is not recommended in patients with an eGFR less than 30 mL/min/1.73 m²
• Assess volume status. In patients with volume depletion, correct this condition before initiating BRENZAVVY [see Warnings and Precautions (5.3), Use in Specific Populations (8.5, 8.6)].

2.2 Recommended Dosage

• The recommended dosage of BRENZAVVY is 20 mg orally taken once daily in the morning, with or without food [see Clinical Pharmacology (12.3)].
• Do not crush or chew the tablet.
• If a dose is missed, take the missed dose as soon as possible. Do not double the next dose.

2.3 Temporary Interruption for Surgery

• Withhold BRENZAVVY for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume BRENZAVVY when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)].

In the event of an overdose of BRENZAVVY, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Employ the usual supportive measures as dictated by the patient’s clinical status. Removal of bexagliflozin by hemodialysis has not been studied.

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].