Bexagliflozin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Bexagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is FDA approved for the treatment of Type 2 Diabetes mellitus. Common adverse reactions include female genital mycotic infections, urinary tract infection and increased urination.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Bexagliflozin is indicated to improve the glycemic control in type 2 diabetes mellitus in adjunct to diet and exercise.
Recommended dosage in one tablet 20mg taken orally once daily with or without meal in the morning. Always assess the renal function prior to initiating the drug. Bexagliflozin is not recommended if eGFR less than 30 mL/min/1.73 m2.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Bexagliflozin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Hypersensitivity to bexagliflozin or any excipient in bexagliflozin tablets. Anaphylaxis and angioedema has been reported in patients taking SGLT2 inhibitors.
Warnings
1. Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: always assess the ketones even if the patient maintains normal blood glucose and discontinue Bexagliflozin if ketoacidosis is present. monitor the patients for ketone resolution prior to resuming Bexagliflozin
2.Lower limb amputation: Bexagliflozin increases the rsik of lower limb amputation. So monitor patients for signs and symptoms of infection, or ulcers of the lower limbs, and discontinue if these occur.
3.Volume depletion: It may cause Acute kidney injury, So always assess and correct volume status in patients with impaired renal function or low systolic blood pressure, elderly patients or patients on diuretics prior to starting Bexagliflozin.
4.Urosepsis and pyelonephritis
5.Hypoglycemia
6.Necrotizing fasciitis of the perineum Template:(Fournier’s Gangrene)
7.Gegintal mycotic infection
Adverse Reactions
Clinical Trials Experience
-Increased urination, Thirst, Hypoglycemia, Urinary tract infection ,Female genital mycotic infections, Vaginal pruritus, vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, Male genital mycotic infection
Postmarketing Experience
There is limited information regarding Bexagliflozin Postmarketing Experience in the drug label.
Drug Interactions
1. UGT enzyme inducer- It may significantly reduce exposure to Bexagliflozin and lead to a decreased efficacy. Therefore, consider adding another anti-hyperglycemic agent for additional glycemic control.
2. Concomitant Use with Insulin and Insulin Secretagogues- increases the risk of hypoglycemia.
3.Lithium : concomitant usage of lithium with Bexagliflozin may reduce the serum Lithium concentration. Thus, monitor serum Lithium concentration on initiation and discontinuation of lithium.
4.Positive urine glucose test: SGLT2 inhibitors causes glucosuria thus showing positive urine glucose test.
5.Monitoring glycemic control with 1,5-AG assay is not recommended while using Bexagliflozin.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C
Based on animal data showing adverse renal effects, bexagliflozin is not recommended during the second and third trimesters of pregnancy due to the adverse events of irreversible renal pelvic and tubule dilatations that were observed in rats.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bexagliflozin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bexagliflozin during labor and delivery.
Nursing Mothers
We advise patients that use of bexagliflozin tablets is not recommended while breastfeeding because of the potential for serious adverse reactions in a breastfed infant, including the potential for bexagliflozin to affect postnatal renal development,
Pediatric Use
There is no FDA guidance on the use of Bexagliflozin in pediatric settings.
Geriatic Use
No differences in the effectiveness of bexagliflozin tablets have been observed between patients 65 years of age and older and younger adult patients. However some events of volume depletion were observed in patients 65yrs and older.
Gender
There is no FDA guidance on the use of Bexagliflozin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bexagliflozin with respect to specific racial populations.
Renal Impairment
Bexagliflozin is avoided in patients with eGFR less that 30 mL/min/1.73 m2 due to the decline of the glucose lowering effect of bexagliflozin tablets and reduction in urine output in these patients.
Patients with renal impairment treated with Bexagliflozin are at increased risk of developing adverse effects of polyuria, polydipsia, genital infections , volume depletion and worsening of renal function.
Hepatic Impairment
There is no FDA guidance on the use of Bexagliflozin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Bexagliflozin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Bexagliflozin in patients who are immunocompromised.
Administration and Monitoring
Administration
Recommended dosage of bexagliflozin tablets is 20 mg orally taken once daily in the morning, with or without food . If a dose is missed, take the missed one as early as possible, never double the dose.
Monitoring
Always assess the renal function prior to start of Bezagliflozin and eGFR should be more than 30 mL/min/1.73 m2 prior to initiation.
Assess the volume status while the patient is on Bezagliflozin.
Withhold bexagliflozin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting and resumed when patient is clinically stable and has oral intake
IV Compatibility
There is limited information regarding the compatibility of Bexagliflozin and IV administrations.
Overdosage
There is limited information regarding Bexagliflozin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bexagliflozin Pharmacology in the drug label.
Mechanism of Action
Bexagliflozin is an inhibitor of sodium-glucose co-transporter 2 (SGLT2),which is a transporter responsible for reabsorption of the majority of glucose from the renal glomerular filtrate in the renal proximal tubule. Therefore bexagliflozin reduces renal reabsorption of filtered glucose by inhibiting SGLT2, and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Structure
There is limited information regarding Bexagliflozin Structure in the drug label.
Pharmacodynamics
There is a Dose-dependent increases in urinary glucose excretion (UGE) accompanied by increases in urine volume were observed in healthy subjects and in adults with type 2 diabetes mellitus following single- and multiple-dose administration of bexagliflozin.
Pharmacokinetics
Bexagliflozin does not exhibit time-dependent pharmacokinetics and accumulates in plasma up to ~20% following multiple dosing.
Nonclinical Toxicology
Bexagliflozin had no effects on mating, fertility or early embryonic development in male or female rats at any dose up to the highest dose of 200 mg/kg/day.
There were no drug-related neoplastic findings in mice or rats
Clinical Studies
There is limited information regarding Bexagliflozin Clinical Studies in the drug label.
How Supplied
Bexagliflozin 20 mg tablets are blue, caplet-shaped, biconvex, bevel-edged, film-coated debossed with “2” and inverted “2” on one side.
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)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Bexagliflozin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Bexagliflozin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Bexagliflozin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Bexagliflozin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.