BRENZAVVY 20 mg/1
Bexagliflozin · TABLET · TheracosBio, LLC
BRENZAVVY is a tablet containing bexagliflozin at 20 mg/1, taken oral. Manufactured by TheracosBio, LLC.
Key Facts
- Brand Name
- BRENZAVVY
- Generic Name
- Bexagliflozin
- NDC Code (Product)
82381-2174- Manufacturer
- TheracosBio, LLC
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA214373
- Drug Class
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Marketing Start
- 07/13/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see Warnings and Precautions ( 5.1 )] . BRENZAVVY is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitation of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended dose: 20 mg once daily, taken in the morning, with or without food. Do not crush or chew the tablet. ( 2.2 ) • Assess renal function before initiating BRENZAVVY and as clinically indicated. Correct volume depletion before initiating ( 2.1 ) • Not recommended if eGFR less than 30 mL/min/1.73 m 2 . ( 2.1 ) • Withhold BRENZAVVY for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting ( 2.3 ). 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 m 2 • 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. 2.3 Temporary Interrupti…
Contraindications
4 CONTRAINDICATIONS 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
Drug Interactions
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 require additional glycemic control. Concomitant Use with Insulin and Insulin Secretagogues Clinical Impact The risk of hypoglycemia is increased when BRENZAVVY is used in combination with insulin and/or an insulin secretagogue. Intervention A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with BRENZAVVY. Lithium Clinical Impact Concomitant use with SGLT2 inhibitors such as BRENZAVVY may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently upon BRENZAVVY initiation and discontinuation. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention Monitoring glycemic contr…
Adverse Reactions
6 ADVERSE REACTIONS 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 Warnings and Precautions ( 5.4 )] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence > 5%) are female genital mycotic infections, urinary tract infection and increased urination. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TheracosBio at 1-855-BRENZAVVY (1-855-273-6928) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and m…
Frequently Asked Questions
What is BRENZAVVY used for?
BRENZAVVY contains Bexagliflozin. It is a tablet taken oral. Consult your doctor for specific uses.
Is BRENZAVVY a controlled substance?
BRENZAVVY is not classified as a controlled substance by the DEA.
What is the generic name for BRENZAVVY?
The generic name for BRENZAVVY is Bexagliflozin. There are 2 other brand versions of Bexagliflozin.
What is the NDC code for BRENZAVVY 20 mg/1?
The NDC (National Drug Code) for BRENZAVVY 20 mg/1 is 82381-2174, listed by TheracosBio, LLC.